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Abstract of dissertation entitled

“Evidence Based Guideline of Prone Positioning for Adult Patients

with Acute Respiratory Distress Syndrome in Intensive Care Unit”

Submitted by

Wong Sze Lok Rebecca

for the degree of Master of Nursing

at The University of Hong Kong

in August 2014

Acute respiratory distress syndrome (ARDS) is a life-threatening condition commonly

seen in critically ill patients. Direct treatment against ARDS which supports the respiratory

system and treats the underlying cause is limited. Furthermore, it may cause

ventilator-induced lung injury when given high doses of oxygen and continued breathing

pressure (Ricard, Dreyfuss & Saumon, 2003). Several researches have found a simple, safe

and inexpensive prone positioning, which improves oxygenation and effectively benefited on

the survival of ARDS patients.

The objectives of this dissertation are (1) to perform a systematic review for a critical

appraisal of the current evidence on prone positioning to improve respiratory status for the

patients with ARDS, (2) to develop an evidence-based guideline and assess the

implementation potential, and (3) to develop an implementation and evaluation plan for

translating the guideline to an adult ICU of a public hospital in Hong Kong.

In order to identify studies that compared prone positioning with the standard practice,

a systematic search was performed with the use of three electronic databases, namely

PubMed (1997-2013), Medline (ProQuest, 1991-2013) and CINAHL (EBSCO host,

1991-2013). 183 articles were identified, and nine randomized controlled trail studies met the

inclusion criteria. The quality of these selected studies was critiqued by using the Scottish

Intercollegiate Guidelines Network. Seven of the selected studies were graded as high quality.

An early, continuous and prolonged prone positioning was concluded beneficial to patient

outcomes with high statistical significance. There were oxygenation improvements, as well as

reduction in both incidences of pneumonia and mortality rate.

The implementation potential includes the transferability, feasibility and

cost-effectiveness of the innovation to the target setting and audience in the local ICU. An

evidence-based guideline of prone positioning for ARDS patients is developed and is

proposed to translate into practice. The implementation plan includes a communication plan

with stakeholders and a pilot test. The guideline will be revised after a six-month pilot trial.

The outcomes of patients, healthcare providers and system will be evaluated after

implementation. The primary outcome of the innovation is oxygenation. According to

previous studies, a 40mmHg increase in ventilation/perfusion ratio at Day 4 of the

intervention will be considered as clinically effective.

Evidence Based Guideline of Prone Positioning for Adult Patients

with Acute Respiratory Distress Syndrome in Intensive Care Unit

by


BSc (HONS) Nursing. H.K.P.U.; RN. H.K.

A dissertation submitted in partial fulfillment of the requirements for

the degree of Master of Nursing

at The University of Hong Kong

August 2014

i

Declaration

I declare that this dissertation and the research work represents my own work, except

where due acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a degree,

diploma or other qualifications.

Signed………………………………………..


ii

Acknowledgements

I would like to express my deepest gratitude to my supervisor, Dr. Athena Hong, for

her continuous kind guidance and support on my dissertation over the past two years. She has

inspired me with valuable ideas, suggestions and criticisms. I would not have finished my

dissertation without her inspiration and guidance.

I would also like to extend my gratitude to the hard working staff members of Master

of Nursing Studies, for their kindness and patience. Last but not the least, I would like to

thank my family and friends for their unconditional love and support throughout my studies.

Their words of encouragement helped me to keep on going even when times are low.

iii

Table of Contents

Declaration………………………………………………………………………………………… i

Acknowledgements………………………………………………………………………………… ii

Table of Contents………………………………………………………………………………….. iii

Lists of Appendices………………………………………………………………………………... vii

List of Abbreviations………………………………………………………………...................... viii

Chapter 1 Introduction

1.1 Background………………………………………........................................... 1

1.2 Affirming the Needs………………………..……………………...........……. 2

1.2.1 Incidence and prognosis of ARDS………………………………..…… 2

1.2.1 Statistics of ARDS in Hong Kong…………………………………....... 3

1.2.3 Current practice of prone positioning……………………………........ 4

1.3 Research Question, Objectives, Significance……………………………….. 4

1.3.1 Research question…………………………………..………………….. 4

1.3.2 Setting objectives………………………………………………….......... 5

1.3.3 Significance……………………………………..………………............. 5

Chapter 2 Critical Appraisal

2.1 Search Strategies……………………………………………………………... 7

2.1.1 Search methodology……………………………………….………….... 7

2.1.2 Keywords……………………………………………..……..……..…… 7

2.1.3 Selection criteria………………………………………………....….…. 8

2.1.3.1 The inclusion criteria……………………………………………..... 8

2.1.3.2 The exclusion criteria…………………………..………………...... 8

2.1.4 Data extraction……………………………………………..……….….. 8

2.2 Appraisal Strategies………………………………………………………….. 9

2.3 Appraisal Results………………………………………………......……….... 9

2.3.1 Searching results……………………………………………..……….... 9

2.3.2 Overview of the selected studies………………………………………. 10

2.3.3 Randomization and concealment allocation ……………….………… 10

2.3.4 Blinding…………………………………………………………….…… 11

2.3.5 Baseline characteristics………………………………………......….… 11

2.3.6 Data collection………………………………………..……………..….. 11

2.3.7 Power calculation……………………………………….……………… 12

iv

2.3.8 Application of the studies………………………………..………….…. 12

2.3.9 Summary of quality appraisal…………………………..…………...... 13

2.4 Summary and Synthesis of Findings…………………………………..……. 13

2.4.1 Study characteristics………………………………………………...…. 13

2.4.2 Subjects’ characteristics……………………………………..………… 14

2.4.3 Intervention……………………………………………….…………..... 16

2.4.4 Control/ comparison………………………………………………...…. 16

2.4.5 Outcome measures and effect size……………………………..……… 17

2.4.5.1 Participants’ ventilation…………………………………..………... 17

2.4.5.2 Incidence of pneumonia………………………………………........ 18

2.4.5.3 Rate of mortality………………………………………………...….. 18

2.4.5.4 Adverse events……………………………...………………………. 19

2.4.6 Data synthesis and implication...…………………………..………….. 20

2.4.6.1 Participants’ ventilation…………………………………….…...…. 20

2.4.6.2 Incidence of pneumonia………………………………………….... 21

2.4.6.3 Rate of mortality…………………………………………………..... 21

2.4.6.4 Adverse events…………………………………………...…………. 22

Chapter 3 Implementation Potential

3.1 Transferability of the Innovation……………….......................…………..... 24

3.1.1 Target setting/ audience ……………………………….....………….… 24

3.1.1.1 Fitness of the setting………………………………………….....…. 24

3.1.1.2 Characteristics of target population……………………………...... 25

3.1.2 Philosophy of care…………………………………………..………...... 25

3.1.3 Benefit sufficient patients…………………………….…....................... 26

3.1.4 Time frame for implementation and evaluation ……..………..…….. 26

3.2 Feasibility of Implementation …………….………………….……………... 27

3.2.1 Freedom to implement and terminate the innovation……….…….… 27

3.2.2 Interference with current staff practice…………………………..…... 27

3.2.3 Organization climate…………………………………..………...…….. 28

3.2.4 Collaboration among departments……………………….………….... 28

3.2.5 Skills training ……………….……………………………..……..…..... 29

3.2.6 Equipment for implementation and evaluation ……………....……... 29

3.3 Cost-Benefit Ratio of the Innovation………………………………….……. 31

3.3.1 Patient’s potential risks and benefits……………………………..…... 31

3.3.2 Potential risks and benefits towards staff and the setting……............ 31

3.3.3 Potential risks of maintaining current practice……............................ 32

3.3.4 Potential material and non-material costs for implementation…....... 32

v

Chapter 4 Developing an Evidence Based Practice Guideline

4.1 Title of the Evidence-Based Practice Guideline……………..……………... 33

4.2 Aim of the Guideline…………………………...…….…….……………….... 33

4.3 Objectives of the Guideline………………………………………………….. 33

4.4 Target Population……………………………………………………......…… 33

4.5 Target Users of the Guideline……………………………...………………... 34

4.6 Grading Scheme of the Guideline…………………………………………… 34

4.7 Practice Recommendations….……………………..……………...………… 34

4.7.1 Assessment……………………………………………………..……….. 34

4.7.2 Initiation and implementation of prone positioning…………………. 35

4.7.3 Monitoring and evaluation……………………………...………...…… 35

4.7.4 Termination …………………………………….……………....……… 36

Chapter 5 Implementation Plan

5.1 Communication Plan with Potential Stakeholders........................................ 37

5.1.1 Identification of the stakeholders………………………………..……. 37

5.1.2 The process of communication plan and implementation strategies.. 38

5.1.2.1 Initiating the proposed innovation………...………..…………....... 38

5.1.2.2 Guiding the proposed innovation………….……………………..... 39

5.1.2.3 Sustaining the proposed innovation………...……………............... 41

5.2 Pilot Study to Try Out the Guideline……..…………………………………. 41

5.2.1 The objectives of pilot study……………………………..……………. 41

5.2.2 Patient recruitment of pilot study….………….….………….…..…… 42

5.2.3 The new evidence based guideline of prone positioning…….….......... 42

5.2.4 Data collection for patient, staff and system outcomes……………… 42

5.2.5 Evaluation of pilot study……………………………..…….….............. 43

Chapter 6 Evaluation Plan

6.1 Identify Outcomes to be Achieved……………………...……………..…...... 44

6.1.1 Patient outcomes………………………….………..……………..….... 44

6.1.2 Healthcare provider outcomes………..…………...…….………….…. 45

6.1.3 System outcomes……………………...……………..…………………. 45

6.2 Nature and Number of Clients to be Involved………………..…………..... 45

6.3 Data Collection, Time and Frequency of Taking Measurements…............. 46

6.4 Data Analysis……………………………………………….……………..….. 48

6.5 Criteria of an Effective the Guideline…………………………………...….. 48

vi

Chapter 7 Conclusion 50

References……………………………………………………..…………….…………... 51

Appendices…………………………………………………………..………….……..… 57

vii

Lists of Appendices

Appendix 1

Search Strategies …...……………………………………………..……………..

57

Appendix 2

Table of Evidence…………………………………………………..…………….

58

Appendix 3

Critical Appraisal of Each Study by SIGN.………..……………………………..

67

Appendix 4

Summary of Critical Appraisal…………………………………………………...

76

Appendix 5

Grades of Recommendations……………………………………………...……..

77

Appendix 6

Cost-benefit Ratio for the Innovation…..……………..……………….…………

78

Appendix 7

Recommendations of the Innovation…...…..………...………………...……...…

79

Appendix 8

Flow of Communication………………………………………………………….

83

Appendix 9

Evaluation Questionnaire of Journal Club……………………………..…….…..

84

Appendix 10

Evaluation Questionnaire of Training Workshop…………………………...……

85

Appendix 11

Evaluation Questionnaire of Pilot Study…………...……………………….……

86

viii

List of Abbreviations

ABG

ACs

ALI

APNs

Arterial blood gas

Associated Consultants

Acute lung injury

Advanced Practice Nurses

ARDS Acute respiratory distress syndrome

ARF Acute respiratory failure

BAL Bronchoalveolar lavage

BMI Body mass index

CI

COS

DOM

EBP

Confidence interval

Chief of Service

Department Operation Manager

Evidence based practice

FiO2 Fraction of inspired oxygen

HR Hazard ratio

ICU Intensive care unit

ISS Injury severity score

LIS Lung injury score

LOS

MOs

Length of stay

Medical Officers

MV

NC

Mechanical ventilation

Nurse Consultant

NIV Noninvasive ventilation

ns Not significance

PaCO2 Partial pressure of arterial carbon dioxide

PaO2 Partial pressure of arterial oxygen

PaO2/FiO2 ratio

PCAs

Ventilation/perfusion ratio

Patient Care Assistants

PEEP Positive end-expiratory pressure

PP Prone position,

RCT Randomized controlled trial

RR Relative risk

SAPS II Simplified Acute Physiology Score II

SIGN Scottish Intercollegiate Guidelines Network

SOFA

Sequential Organ Failure Assessment

ix

SPSS

UP

The Statistical Package for Social Science

Upright position

VAP Ventilator-associated pneumonia

VC

WCC

WM

Volume control

White cell count

Ward Manager

1

Chapter 1

Introduction

1.1 Background

Acute respiratory distress syndrome (ARDS) is commonly developed in critically ill

patients. It is a serious and life-threatening condition. The lungs suffer from severe

widespread injury, which results in insufficient oxygen from getting to the lungs and into the

bloodstream (Matthay, Ware & Zimmerman, 2012). According to the Bernard et al. (1994),

the American-European Consensus Conference characterized three clinical features of ARDS:

1) bilateral lung infiltrates on the chest radiograph; 2) severe hypoxemia with

ventilation/perfusion (PaO2/FiO2) ratio less than 200mmHg, irresponsive of positive end

expiratory pressure (PEEP) level; 3) no sign of left arterial hypertension or pulmonary

capillary wedge pressure is less than 18mmHg. Besides, the Berlin definition (2012)

classified the severity of ARDS with the basis on the degree of hypoxemia: mild (200mmHg<

PaO2/FiO2≦300mmHg), moderate (100mmHg < PaO2/FiO2≦200mmHg), and severe

(PaO2/FiO2< 100mmHg).

The onset of ARDS is acute and sudden. It usually develops over 4 to 48 hours and

lasts for days, even weeks (Sharma, 2010). The occurrence of ARDS depends on several

factors. The common causes of ARDS are bacterial or viral pneumonia, such as H1N1

influenza, sepsis due to non-pulmonary infection, aspiration of gastric contents into lungs and

2

major trauma. Once people develop ARDS, they become severe dyspnea and cyanosis. At

worst, mechanical ventilation is required for respiratory failure. The function of other organ

deteriorates quickly due to insufficient oxygen supply. As a result, these patients are at high

risk of death if appropriate treatments are not carried out immediately.

Patients with ARDS in the intensive care unit (ICU) are very critical. Direct treatment

against ARDS that supports the respiratory system and treats the underlying cause is limited.

Respiratory support mainly focuses on mechanical ventilation which aims to give high doses

of oxygen and continued breathing pressure. It may cause ventilator-induced lung injury by

over-distention and eventually worsens the function of the lungs (Ricard, Dreyfuss &

Saumon, 2003). Other than mechanical ventilation, prone positioning is one of the most

effective and safe supportive treatment for ARDS patients. However, it is rarely used in the

ICU.

1.2 Affirming the Needs

1.2.1 Incidence and prognosis of ARDS

A few statistical reports have shown most episodes of ARDS are associated with

common causes or predisposing conditions. 10% to 15% of all ICU patients and up to 20% of

mechanically ventilated patients developed ARDS in the United States (Frutos-Vivar, Nin &

Esteban, 2004). Studies conducted by Rubenfeld et al. (2005) noted the incidence of acute

lung injury (ALI) was 79 people per 100,000 populations per year, whereas 59 people per

3

100,000 populations met the criteria of ARDS. However, the most common cause of death for

ARDS was closely related to the number of organ systems involved. About 15% to 30%

mortality resulted from respiratory failure alone, whereas up to 80 % mortality involved three

or more organ failures. The crude mortality rate of ARDS was high, ranging from 34% to

58%, which increased with advancing age as well (Sharma, 2010). In Iceland, the length of

ICU stay for ARDS patients was about 21 days and the hospital stay was 39 days

(Sigvaldason et al, 2006). With the high mortality rate and long recovery period of ARDS

patients, it created a major consequence to the health care system. Fortunately, recent

researches have shown that applying an early, continuous and prolonged prone positioning to

severe ARDS patients led to a 20% decrease in the mortality rate (Guerin et al., 2013).

Voggenreiter et al. (2005) also suggested that the prevalence rate of ARDS was decreased by

prone positioning.

1.2.2 Statistics of ARDS in Hong Kong

In Hong Kong, pneumonia and septicemia were the third and the eighth leading cause

of death in 2011 (The Department of Health, 2012). Roughly estimated by clinical experience,

about 70% of patients were diagnosed with bacterial or viral pneumonia or sepsis in the target

ICU. The ICU admission rate of patients with pneumonia increased sharply especially during

flu season. These patients were high at risk to develop ARDS. However, there was no

statistical record of ARDS incidences in the target setting.

4

1.2.3 Current practice of prone positioning

Although many researchers has proved that prone positioning is effective in improving

oxygenation for up to 70% of patients with ARDS (Albert et al., 1987; Blanch et al., 1997;

Chatte et al., 1997; Lamm et al., 1994; Pelosi, et la., 1998), it is not used as the primary

treatment strategy in the current clinical practice. It is usually considered as a final rescue

maneuver that acts as the last chance to the patients, when the mechanical ventilation setting

reaches the maximum level and fails to maintain good oxygenation. It is comparatively late to

start prone positioning. The initiation, duration and frequency of prone positioning are

prescribed based on clinical judgments of Medical Officers (MOs). The intermittent and short

duration of prone positioning is usually prescribed. However, there is a lack of standardized

guidelines and training of prone positioning for ARDS patients in existing practice. Nurses

are unfamiliar with the technique of prone positioning. With the proposed guideline, it

provides nurses with knowledge of when to start the procedure, recommended duration of

prone positioning, the proper technique of prone positioning and the following consistent

nursing care.

1.3 Research Question, Objectives, Significance

1.3.1 Research question

A clinical question was formulated: How does prone positioning affect the respiratory

status of adult ARDS patients in compared to supine positioning in terms of safety and

5

effectiveness.

1.3.2 Setting objectives

The objectives of this translation nursing research were:

1) To review the evidence on the effectiveness of prone positioning among ARDS

patients in improving oxygenation, secondary to the patients’ survival rate.

2) To appraise, summarize and synthesize the selected research findings.

3) To develop evidence based prone positioning guidelines for adult ARDS patients

in the ICU.

4) To establish an implementation and evaluation plan for the proposed guidelines.

1.3.3 Significance

As mentioned before, the proposed prone positioning is a simple, safe and inexpensive

treatment for ARDS patients. It leads to better oxygenation by enhancing the recruitment of

collapsed alveoli in the dorsal lung regions (Guerin et al., 1999; Lamm et al., 1994; Pappert et

al., 1994). Therefore, an improvement of gaseous exchange is resulted from minimized heart

compression force to the lungs (Albert & Hubmayr, 2000).

Prone positioning facilitates patients with ARDS in ventilating oxygen that is less toxic

and lower in concentration. The pressure of inflation is also reduced, which prevents

ventilator-induced lung injuries and delays multi-organ failure. Hence, the prognosis and

outcomes of patients are greatly improved.

6

In order to carrying out prone positioning, ICU health care professionals’ training is

required particularly in proper and safe positioning of patients, tubes and catheters during

position changes. The role of nurses is essential in performing and monitoring prone

positioning. Familiarization of the etiology of ARDS and recognition of the need for a prompt

and proper prone positioning not only improves the patients’ prognosis, it also helps to

maintain a good nursing standard.

For institution consideration, neither extra material nor manpower is needed to perform

the proposed intervention. Medical expenses would be reduced greatly due to less oxygen

used in prone positioning.

7

Chapter 2

Critical Appraisal

The searching strategies for relevant studies with regard to prone positioning among

ARDS patients in ICU were described in this chapter. The findings and data from the studies

were extracted and summarized in the table of evidence. Critical appraisal and quality

assessments were discussed together with summary and synthesis of available data.

2.1 Search Strategies

2.1.1 Search methodology

A systematic search was performed from 1st June 2013 to 15

th August 2013 with the use

of PubMed (1997-2013), Medline (ProQuest, 1991-2013) and CINAHL (EBSCO host,

1991-2013). Other electronic databases such as the British Nursing Index and Google scholar,

and reference lists of the selected studies were also used in the search. However, the studies

were all duplicated. Hence, only the search results in PubMed, Medline and CINAHL were

presented.

2.1.2Keywords

The keywords were categorized into three groups: population, intervention and

outcome. “ARDS patients”, “acute respiratory distress”, “acute respiratory distress

syndrome”, “acute respiratory failure” and “early acute respiratory distress syndrome” were

searched under population; “prone position”, “prone positioning”, and “prone position

8

ventilation” were searched under intervention; “oxygenation”, “oxygen saturation”, “oxygen

consumption” and “ventilation perfusion ratio” were searched under outcome. All selected

studies were in English language and there was no restriction on the year and types of

publication.

2.1.3 Selection criteria

In order to select the appropriate and relevant articles, a number of selection criteria

were established:

2.1.3.1 The inclusion criteria

Randomized controlled trial (RCT) studies focusing on prone positioning intervention

in compared to supine positioning in the ICU were included. Study participants should be 18

years old or above and diagnosed with ARDS. The participants should be intubated and

received mechanical ventilation. The outcome of the studies should be related to the patient’s

respiratory status.

2.1.3.2 The exclusion criteria

Studies conducted on infants or children were excluded. Outpatient population was

excluded in this searching strategy. Studies without a full text were also excluded.

The details of the searching strategies and results were presented in Appendix 1.

2.1.4 Data extraction

Studies were retrieved according to the inclusion criteria, and then excluded if within

9

the exclusion criteria. Nine studies were extracted from the results. The data from these

studies were summarized in the table of evidence, which was developed by the Scottish

Intercollegiate Guidelines Network (SIGN) (2012). The data were categorized into several

components: author(s) and year of publication, study type, level of evidence, participant

characteristics, intervention(s), comparison/control, outcome measures and effect size. The

table of evidence was presented in Appendix 2.

2.2 Appraisal Strategies

A number of methodologies were described in order to appraise the research evidence

critically and to grade the recommendation based on the level of evidence. With the use of

methodology checklist from the Scottish Intercollegiate Guidelines Network (SIGN, 2012),

the quality of nine selected studies was critiqued. The checklists for critical appraisal of the

nine selected studies were presented in Appendices 3 & 4. The details of grading system

developed by SIGN were shown in Appendix 5.

2.3 Appraisal Results

2.3.1 Searching results

A total of 952 articles were retrieved on 15th

August, 2013 from three databases. After

screening the titles and abstracts, there were 183 potential articles related to the topic. 32

articles were considered as eligible studies with RCT studies screening. Six articles were

excluded, as the studies populations were infants and children. Seven articles were excluded,

10

as the full texts were not available. Three articles were further excluded after the conduction

of observation prospective studies. Three articles were excluded, as the outcome measures of

the studies were not related to the respiratory status of the population. Two articles were

excluded, as prone position was not the only compared intervention in the study. One article

was excluded as it was written in German. Another article was excluded as it was a pilot

study. In the end, nine articles met the selection criteria and were included in this review.

2.3.2 Overview of the selected studies

As discussed above, nine RCT studies in total were selected after systematic search.

The critical appraisal table of the studies was presented in Appendices 3 & 4. In general, all

studies had set an appropriate and focused research question that clearly stated the target

population, the intervention and the outcome measures. The questions of all studies were

similar to research question proposed.

2.3.3 Randomization and concealment allocation

Seven studies carried out good randomization by computer generated system

(Fernandez et al., 2008; Guerin et al., 2004; Guerin et al., 2013; Mancebo et al., 2006) or

centralized telephone system operated on a 24-hours-a day, 7-days-a-week basis and were

based on a permuted-block algorithm (Gattinoni et al., 2001; Taccone et al., 2009;

Voggenreiter et al., 2005). Only two studies mentioned randomization was done without any

method descriptions (Papazian et al., 2005; Robak et al., 2011). All participants were well

11

allocated into certain groups by opaque, sealed envelopes or central allocation.

2.3.4 Blinding

For prone positioning ventilation studies, it was impossible to blind either participants

or health care professionals due to their active involvement in the intervention. Therefore, six

selected studies did not describe any blinding process. Guerin et al. (2004) claimed that

neither data collectors nor outcome assessors were not blinded in their study; only two studies

blinded the investigators (Taccone et al., 2009) and outcome assessors (Guerin et al., 2013).

2.3.5 Baseline characteristics

In terms of the baseline characteristics of the participants between groups, three studies

showed p-value with insignificant results (Fernandez et al., 2008; Mancebo et al., 2006;

Voggenreiter et al., 2005). Taccone et al.’s study (2009) showed the characteristics of the

participants without statistical description. The rest of the five studies described the details of

baseline characteristics without presenting the p-value and claimed no statistical difference

between intervention and control groups. In addition, the primary outcome measures used

were clearly stated in all studies, the only difference between the groups was prone

positioning.

2.3.6 Data collection

The data from the groups were collected in the same way at the same period of time, in

order to minimize performance bias. The outcomes among the selected studies were

12

measured by blood test, chest radiography, ventilator setting, bronchoalveolar lavage (BAL),

physiological variables and biochemical variables etc. They were all standard, valid and

reliable methods.

2.3.7 Power calculation

The method of statistical analysis was stated clearly in all studies. The dropout rate was

low with the range of 0 to 8.7% in most of the studies. Three studies did not describe any

dropouts (Gattinoni et al., 2001; Papazian et al., 2005; Robak et al., 2011). The intention to

treat analysis was eventually carried out in six studies (Gattinoni et al., 2001; Guerin et al.,

2004; Guerin et al., 2013; Mancebo et al., 2006; Taccone et al., 2009; Voggenreiter et al.,

2005). Other studies counted in all participants for intention to treat analysis because none of

them were lost from the follow-up. Four studies were limited by small sample size, the

findings resulted in a low statistical power (Fernandez et al., 2008; Gattinoni et al., 2001;

Mancebo et al., 2006; Voggenreiter et al., 2005).

2.3.8 Application of the studies

Seven studies carried out the research in multi-centres, the exceptions being studies of

Papazian et al. (2005) and Robak et al. (2011). The overall effects of the nine studies were

due to the prone positioning. Since all the selected studies were performed in the ICU, the

study population was similar to that in the target setting without racial consideration. Hence,

the findings of the selected studies were generalized and directly applicable to the targeted

13

patients.

2.3.9 Summary of quality appraisal

According to the SIGN appraisal checklist for RCT, the quality of the selected studies

rated from 1++ to 1- (SIGN, 2012). One was identified as high quality (Guerin et al., 2013),

six studies were identified as acceptable (Fernandez et al., 2008; Gattinoni et al., 2001;

Guerin et al., 2004; Mancebo et al., 2006; Taccone et al., 2009; Voggenreiter et al., 2005) and

two studies were identified as low quality (Papazian et al., 2005; Robak et al., 2011). The

parentage of criteria fulfilled ranged from 58% to 100%. Those studies identified as low

quality contained poor randomization description; no blinding was performed and poor

intention to treat analysis.

2.4 Summary and Synthesis of Findings

Data from the selected studies were categorized and summarized in the table of

evidence (Appendix 2). The synthesis of the findings was discussed below.

2.4.1 Study characteristics

The nine selected studies were all RCTs. The studies were published from 2001 to 2013.

Two studies were conducted in France (Guerin et al., 2004; Papazian et al., 2005). The others

were conducted in Germany, Italy, Switzerland, Spain, Mexico and Austria (Fernandez et al.,

2008; Gattinoni et al., 2001; Guerin et al., 2013; Mancebo et al., 2006; Robak et al.,

2011;Taccone et al., 2009; Voggenreiter et al., 2005). No local study was retrieved. Seven

14

studies were conducted in a multi-centre design with the range of 2 to 30 ICU centres.

(Fernandez et al., 2008; Gattinoni et al., 2001; Guerin et al., 2004; Guerin et al., 2013;

Mancebo et al., 2006; Taccone et al., 2009; Voggenreiter et al., 2005 ). The rest of the studies

were a single centre design conducted in a medical ICU.

2.4.2 Subjects’ characteristics

2184 participants in total enrolled in the nine studies. The number of participants in

each study ranged from 20 (Robak et al., 2011) to 791(Guerin et al., 2004). 1126 participants

in total were randomized to receive prone positioning. Participants in five studies were

diagnosed with ARDS by the definition of the American-European Consensus Conference

(Fernandez et al., 2008; Guerin et al., 2013; Mancebo et al., 2006; Papazian et al., 2005;

Taccone et al., 2009). The other three studies included participants with either ALI or ARDS

(Gattinoni et al., 2001; Voggenreiter et al., 2005; Robak et al., 2011), whereas Voggenreiter et

al.’s study (2005) mainly focused on trauma patients. Besides, the largest study enrolled

participants with acute hypoxemia respiratory failure including 51% ALI or ARDS and 7%

acute cardiogenic pulmonary edema (Guerin et al., 2004). Patients in all studies were

intubated and required mechanical ventilation.

About 40% to 83% were male ranging from 42 to 67 year olds. Simplified Acute

Physiology Score II (SAPS II) of participants was calculated in eight studies, the exception

being Voggenreiter et al. one (2005). The SAPS II mean ranged from 38.3 to 52, where higher

15

scores indicated greater severity of symptoms (SAPS II range: 0-164). Five studies carried

out a Sequential Organ Failure Assessment (SOFA) score to the participants with a mean

score of 6.8 to 12, where higher scores indicated more organ failure (SOFA score range: 0-24)

(Fernandez et al., 2008; Guerin et al., 2013; Papazian et al., 2005; Taccone et al., 2009;

Voggenreiter et al., 2005). In terms of the ARDS causes, 18% to 75% of the participants had

pneumonia, 3% to 23.5% of ARDS participants were associated with sepsis, whereas 3% to

36% participants were triggered by aspiration (Guerin et al., 2013; Gattinoni et al., 2001;

Mancebo et al., 2006; Papazian et al., 2005; Robak et al., 2011; Taccone et al., 2009;

Voggenreiter et al., 2005).

Arterial blood gas measurements were performed in all studies at the time of inclusion,

mean PaO2/ FiO2 ratio of participants ranged from 100 (Guerin et al., 2013) to 155.5

(Fernandez et al., 2008), mean partial pressure of arterial oxygen (PaO2) was 80 mmHg

(Guerin et al., 2013) to 116.5mmHg (Mancebo et al., 2006) and mean partial pressure of

arterial carbon dioxide (PaCO2) ranged from 37 mmHg (Voggenreiter et al., 2005) to 57

mmHg (Robak et al., 2011). When it comes to the initial ventilator settings, the fraction of

inspired oxygen (FiO2) mean ranged from 0.49 (Voggenreiter et al., 2005) to 0.82 (Mancebo

et al., 2006), while the PEEP mean ranged from 7.7 (Guerin et al., 2004) to 13.2 (Fernandez

et al., 2008).

16

2.4.3 Intervention

At the beginning of the intervention, participants in two studies received prone

positioning ventilation within an hour after randomization (Guerin et al., 2013; Mancebo et

al., 2006). Whereas the other studies, the intervention started within two to three days after

diagnosis (Fernandez et al., 2008; Guerin et al., 2004; Taccone et al., 2009). Mancebo et al.

(2006) concluded the time between diagnosis and randomization in prone positioning group

was 0.89 day. The mean time between trauma diagnosis and the beginning of intervention in

Voggenreiter et al.’s study (2005) was the longest. An average of five days were spent to

allocate participants into different group.

Participants received prone positioning ventilation for 7 to 20 hours per day. Two

studies continued prone positioning in a specific period (Papazian et al., 2005; Robak et al.,

2011), whereas the others continued the intervention until clinical improvement was reached.

The intervention period ranged from a day (Papazian et al., 2005; Robak et al., 2011) to ten

days (Gattinoni et al., 2001; Mancebo et al., 2006). One study combined upright and prone

positions to compare with supine position (Robak et al., 2011).

2.4.4 Control/ Comparison

In the comparison group, participants remained supine positioning ventilation in most

of the studies. Two studies assigned participants in comparison group to stay in semi

recumbent position (Guerin et al., 2004; Guerin et al., 2013). The use of high-frequency

17

oscillation was considered as an additional therapy that was applied to all participants

(Papazian et al., 2005). Lung protective ventilation was applied except in the studies of

Gattinoni et al. (2001) and Guerin et al. (2004). Crossover was strictly prohibited in two

studies (Robak et al., 2011; Voggenreiter et al., 2005), while two other studies allowed

crossover (Gattinoni et al., 2001; Mancebo et al., 2006), the rest allowed crossover only as a

rescue measure.

2.4.5 Outcome measures and effect size

2.4.5.1 Participants’ ventilation

Eight out of nine selected studies measured the PaO2/FiO2 ratio of the participants.

There was a significant increase in PaO2/FiO2 ratio in prone positioning among these eight

studies. These increased findings were +75 at Day 3(p=0.009) (Fernandez et al., 2008); +18.4

(p= 0.02) (Gattinoni et al., 2001); p<0.001 (Guerin et al., 2004); +15 at Day 3 (p<0.05) and

+22 at Day 5 (p< 0.001) (Guerin et al., 2013); +39 (p<0.005) (Mancebo et al., 2006); +79

(p<0.0001) and +101 (p<0.001) (Papazian et al., 2005); +56 (p<0.05) and +55 (p<0.001)

(Robak et al., 2011) and +44.1 at Day 4 (p=0.03) (Voggenreiter et al., 2005). Study of

Fernandez et al. (2008) showed the largest increase of the PaO2/FiO2 ratio, while Robak et

al.‘s study (2011) showed the shortest period (two hours after implementation) with a

significant increase. Besides, three studies have found a significant reduction of PEEP used

among the intervention group. This reduction showed statistical significance at Day 3 (Guerin

18

et al., 2013) and Day 4 (Mancebo et al., 2006; Voggenreiter et al., 2005) with p-value less

than 0.05, equal to 0.048 and 0.009 respectively. In addition, Mancebo et al. (2006) found

there was a drop with 2 cmH2O of PEEP in intervention group. When it comes to FiO2 used,

two studies showed a significant decrease in prone positioning (Guerin et al., 2013; Mancebo

et al., 2006). This reduction protected participants from oxygen toxicity. With the

improvement of PaO2/FiO2 ratio, reduction of PEEP and FiO2 used, the number of

participants in prone position who had extubated successfully at Day 90 was significantly

higher than those in supine position (p<0.001) (Guerin et al., 2013).

2.4.5.2 Incidence of pneumonia

Only two studies measured the incidence of pneumonia during the implementation.

Voggenreiter et al. (2005) found that the prevalence of pneumonia in prone position group

was significantly lower than those in supine position by 27% (p=0.048). Another study

showed a significant reduction of 3.5 % in ventilator-acquired pneumonia (VAP) in

intervention group (p= 0.045) (Guerin et al., 2004).

2.4.5.3 Rate of mortality

Seven studies measured mortality rate of the participants as one of the outcomes.

However, the measurement periods of mortality were different. Gattinoni et al. (2001)

concluded a 3.9% reduction at Day 10 in prone positioning group (p=0.65). There was a 15%

decrease (p=0.3) in 60-day mortality in prone position in Fernandez et al.’s study (2008). Two

19

studies measured 28-day and 90-day mortality. These findings in prone positioning were

-0.9% (p=0.77) and -1.1% (p=0.74) respectively (Guerin et al., 2004), while -16.8% (p<0.001)

and -17.4% (p<0.001) respectively in Guerin et al.’s study (2013). Mancebo et al.’s study in

2006 showed the ICU mortality of participants in prone positioning had a 15% absolute and

25% relative decrease compared with those ventilated supine (p=0.12), they also measured

the hospital mortality with 12% reduction in prone positioning (p= 0.27). The mortality

decreased 11 % in intervention group with p-value equal to 0.27 (Voggenreiter et al., 2005).

Taccone et al. (2009) noted 28-day and 180-day mortality of moderate ARDS participants in

intervention group were +3% (p=0.62) and -1.3% (p=0.85) respectively, while for severe

ARDS participants, the rates were -8.3% (p=0.631) and -10.5% (p=0.19) respectively. This

showed that the mortality of severe ARDS participants had a greater decrease than those

suffered from moderate ARDS. Although the mortality of ARDS in prone positioning reduced

in most of the studies, the statistical significance did not reach. Only the study of Guerin et al.

(2013) presented a significant reduction in 28-day and 90-day mortalities.

2.4.5.4 Adverse events

Main complications related to prone positioning included pressure sore formation,

device displacement such as endotracheal tube and venous access, hemodynamic instability,

arrhythmia and edema. Four studies concluded the occurrence of the adverse events resulted

from prone positioning was insignificant (Gattinoni et al., 2001; Guerin et al., 2013; Mancebo

20

et al., 2006; Voggenreiter et al., 2005). Gattinoni et al. (2001) found there was a statistical

insignificance in the complications except the occurrence of pressure sore in prone

positioning. It was a 0.8 increase in the number of new or worsening pressure sore with

p-value equal to 0.004. Taccone et al. (2009) claimed that the incidence of the adverse events

such as the increased of sedation and paralyzing drugs, hemodynamic instability and

displacement of devices were significantly higher in intervention group (+18.2%, p<0.001).

Finally, Guerin et al. (2004) found prone positioning significantly increased the incidence of

selective intubation, endotracheal tube obstruction and pressure sores with p=0.01, p=0.002

and p=0.005 respectively.

2.4.6 Data synthesis and implication

From the data mentioned above, prone positioning benefited ARDS participants in

oxygenation improvement, decreases in pneumonia rate and possibly mortality rate. It was

concluded that the disease severity of the participants varied in the early studies (Gattinoni et

al., 2001; Guerin et al., 2004; Voggenreiter et al., 2005). They recruited patients with acute

respiratory failure including both ALI and ARDS. The duration of prone positioning

performed was relatively shorter. Less than 12 hours/day were spent for the intervention

intermittently and did not use lung protective ventilation.

2.4.6.1 Participants’ ventilation

There was a trend to perform prone positioning at early stage that within 48 hours after

21

diagnosis in recent studies (Fernandez et al., 2008; Guerin et al., 2013; Mancebo et al., 2006).

The most recent studies only recruited patients with similar severity of ARDS. Prolonged

prone positioning was performed more than 17 hours/day. Patients were only turned to supine

position for a few hours to carry out daily nursing care or medical treatment. Prone

positioning was continued every day until significant improvement in oxygenation. A

significant clinical improvement was found within three days of implementation period

(Fernandez et al., 2008). Besides, patients ventilated with recent protective lung ventilation

prevented them from ventilator-induced lung injury.

2.4.6.2 Incidence of pneumonia

Since two studies concluded the incidence of pneumonia showed a significant drop

with prone position (Guerin et al., 2004; Voggenreiter et al., 2005), it might be related to the

drainage effect of secretions when patients remained at prone position, aspirations could be

prevented.

2.4.6.3 Rate of mortality

When it comes to the effect in mortality, the findings of the studies were inconclusive.

Although there was a decrease in mortality in prone position, the statistical significance did

not meet. It may be due to a small sample size in four studies (Fernandez et al., 2008;

Gattinoni et al., 2001; Mancebo et al., 2006; Voggenreiter et al., 2005), in which two studies

were stopped prematurely due to medical contraindications of prone positioning, shortened

22

period of enrollment (Fernandez et al., 2008) and unwillingness of caregivers (Mancebo et

al., 2006). The large spectrum of disease severity among the selected patients resulted in the

unclear influence of mortality (Gattinoni et al., 2001; Guerin et al., 2004; Voggenreiter et al.,

2005). Besides, the cause of ARDS mortality was mainly related to multi-organ failure rather

than respiratory failure alone. Taccone et al. (2009) allowed a 72-hour enrollment period that

might explain insignificant result. It violated the principle of early intervention, led to more

effective outcome (Mancebo et al., 2006). At last, Guerin et al. (2013) carried out the study

with sufficient sample of ARDS patients and early implemented prolonged prone positioning

with lung protective ventilation, led a significant decrease of mortality.

2.4.6.4 Adverse events

For the adverse events of the prone positioning, there were insignificant results among

most of the studies. Gattinoni et al. (2001) found incidence of pressure sore significantly

increased in prone positioning, it was explained by late enrollment of the ARDS patients that

nearly 25% of them had pressure sore at entry and a lack of protective measures done. The

use of cushions or protective pads in recent studies reduced the incidence of prevent pressure

sores effectively (Mancebo et al., 2006; Robak et al., 2011; Guerin et al., 2013). The increase

of selective intubation, endotracheal tube obstruction and devices displacement might relate

to the unfamiliar technique turning procedure (Guerin et al., 2004). In fact, the adverse events

of prone positioning were reversible and preventable; the use of appropriate tuning guidelines

23

and nursing care protocol could minimize the occurrence of the complications.

In conclusion, prone positioning is a simple, safe and cheap supportive treatment. A

number of benefits for ARDS patients showed in oxygenation improvement, pneumonia and

mortality reductions after the review of studies. It should be implemented early within 48

hours after diagnosis (Fernandez et al., 2008; Guerin et al., 2013; Mancebo et al., 2006). The

duration of prone positioning should be prolonged at least 17 hours per day (Fernandez et al.,

2008; Guerin et al., 2013; Mancebo et al., 2006; Taccone et al., 2009) and it should continue

the treatment every day until clinical improvement noted (Guerin et al., 2013). Besides, lung

protective ventilation should be performed. Appropriate turning guidelines and nursing care

protocol can prevent several complications of prone positioning.

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Chapter 3

Implementation Potential

In previous chapters, prone positioning has been proved as an effective measure of

oxygenation improvement for the patients with ARDS. With the consideration of the potential

benefits, the innovation will be transferred to ICU of a public hospital in Hong Kong. The

target audience and setting, transferability, feasibility and cost-benefit ratio of the innovation

will be considered before actual transfer.

3.1 Transferability of the Innovation

3.1.1 Target setting/ audience

The evidence-based guideline of prone positioning will be proposed in the ICU of a

public hospital. A total of eight beds are served and the average bed occupancy rate is about

80%. The target setting provides services to those adult patients with different types of

critically ill diagnosis including medical illness (30%), surgical illness (36%), orthopedic

illness (12%) or ear, nose and throat illness (22%) based on the statistics from the target

setting in 2012.

3.1.1.1 Fitness of the setting

None of the selected studies was conducted in Hong Kong, which may have racial

barrier when transferring the innovation to Hong Kong audience. However, all selected

studies were carried out in ICU and the patients in the studies suffered from ARDS. The

25

clinical settings in the selected studies are similar to the target setting. The transferability of

prone positioning is still high.

3.1.1.2 Characteristics of target population

The target audience will be the adult patients who receive mechanical ventilation and

develop ARDS after ICU admission. The eligible patients in the selected studies are similar

characteristics to the target audience in terms of diagnosis and treatment of the disease.

Patients in most of the selected studies mainly have pneumonia and sepsis, which are the

common diagnosis in the target setting (Gattinoni et al., 2001; Guerin et al., 2013; Mancebo

et al., 2006; Papazian et al., 2005; Robak et al., 2011; Taccone et al., 2009; Voggenreiter et al.,

2005). There is no geographic barrier in selecting appropriate clinical setting and audience.

Hence, the innovation is suitable for the target setting.

3.1.2 Philosophy of care

‘Helping people stay healthy’ is the mission of Hospital Authority (Hospital Authority,

2013). As health care professionals, we have an important responsibility of not only giving

life-saving treatment to our patients, but also assisting them to regain their health and stay

healthy. The service goal of target setting is to provide patients with the safe, high-quality and

evidence-based services for their best possible outcomes. The philosophy of innovation is to

improve ventilation when patients have life-threatening ARDS. It further reduces the

mortality rate by 17% regarding to Guerin et al.’s study (2013). Using the evidence-based

26

guideline of prone positioning in the target setting, the prognosis among patients will be

improved. Therefore, the philosophy of the innovation achieves the missions of both Hospital

Authority and the target setting.

3.1.3 Benefit sufficient patients

The innovation will benefit patients who have ARDS and require mechanical

ventilation. Based on the annual admission rate of the target setting in 2012, around 400

patients admitted to the target setting and about 40% of them were diagnosed with pneumonia

or sepsis. However, not all of these patients reached the criteria of the proposed innovation. It

is estimated that 100 of patients will benefit from the proposed innovation every year. The

number of target audience is increasing due to the increased severity of pneumonia that is

associated with Human Swine Influenza or Avian Influenza (H7N9) these years (WHO,

2013).

3.1.4 Time frame for implementation and evaluation

A pilot study of the innovation will be commenced in the target setting. The duration

will last for six months for implementation and evaluation. Prone positioning will be

implemented on the day of ARDS diagnosis and will be continued until patients’ ventilation

is improved. It will last at least 4 days for every eligible patient (Guerin et al., 2013) and the

evaluation will be conducted every day in order to find out any barrier of the innovation. The

mortality rate of the target audience will be evaluated one month after the implementation

27

(Guerin et al., 2004; Taccone et al., 2009; Guerin et al., 2013).

3.2 Feasibility of Implementation

3.2.1 Freedom to implement and terminate the innovation

Primary nursing practice has been promoted for more than six years in the target setting.

Each primary nurse is responsible for one to two patients. Hence, nurses have autonomy to

make decision by following the evidence-based guideline together with their clinical

judgment. They will have the freedom to implement the innovation after gaining the approval

from the Department Operation Manager (DOM). If the adverse events occur, nurses will

notice, report and terminate the innovation immediately.

3.2.2 Interference with current staff practice

As prone positioning is a new innovation, it requires more manpower to implement

comparing with the standard turning procedure especially for the patients who have different

central venous accesses, tracheal tube and monitoring instruments. During each turning, at

least five staffs are involved and it usually takes five to ten minutes for the process (De Jong

et al., 2013; Mancebo et al., 2006). Since the total bed number is small, there are about ten

health care providers including nurses and Patient Care Assistants (PCAs) are on duty during

day shift, nearly 50% of them will assist for prone positioning and it will create minor

interference to the current setting. As the procedure is not time-consuming, it should be

implemented in the morning duty in order to ensure sufficient manpower and minimize the

28

interference made.

3.2.3 Organization climate

Evidence-based practice (EBP) of nursing practice is positively supported within the

target setting. Under the leadership of a DOM, Nurse Consultant (NC) and Advanced Practice

Nurses (APNs) play an important role in project co-ordination and implementation. In order

to implement this innovation, monthly journal club and weekly nursing grand round are the

prefect communication channels between NC, APNs and nurses to share updated research

findings and nursing care. Knowledge of the new innovation will be reinforced during the

group sharing.

Besides, nurses can express their concerns and barriers that they encounter in ward

meeting. Their feedback enhances the evaluation and modification of the innovation.

3.2.4 Collaboration among departments

As the innovation is being implemented, the collaboration among the health care

providers within or outside the department is extremely crucial. The proposed innovation will

be introduced to MOs first who are responsible for making a precise diagnosis of ARDS,

holding patient’s head during the proning process and further weaning the ventilator setting.

If the patient does not coordinate with the mechanical ventilation after prone positioning,

nurses will discuss with MOs in order to seek for sedation or paralyzing agents to the

patients.

29

The innovation needs to gain collaboration with laboratory and x-ray department in

order to evaluate the outcomes. For example, regular blood taking, culture testing from

endotracheal aspirates and chest x-ray will show any oxygenation improvement or presence

of chest infection. The laboratory and x-ray department are unlikely oppose the innovation

since there is no extra investigation which interferes their daily function.

3.2.5 Skills training

Staff training will be conducted before the guideline implementation. After the research

findings sharing in journal club and nursing grand round, a one-hour workshop will be held to

reinforce the specific technique of prone positioning. PCAs will be instructed to be the

assistants in the proning process. Nurses will supervise and ensure PCAs to stand at correct

position. Nurses will also assist in proper positioning to ensure patient’s safety such as

securing all life-saving materials throughout the process.

Besides, nurses will be taught about the monitoring and adverse events of prone

positioning. Shift assessment of the patient’s skin integrity will be done to elevate any

formation of pressure sore. Poor nurses’ turning technique will be one of the barriers

concerned. Department audit team in order to review the nursing practice and maintain the

standard of care will conduct an audit of prone positioning.

3.2.6 Equipment for implementation and evaluation

Comparing with the standard turning position, there will be no extra pillow used in

30

prone positioning. Three pillows will be placed under the shoulders, the pelvis and shins in

order to reduce the restriction of the chest and abdominal movements (Guerin et al., 2004;

Guerin et al., 2013; Mancebo et al., 2006; Robak et al., 2011). Besides, a manufactured prone

headrest will be purchased in order to protect and support patient’s head and face. Since this

device is reusable, two prone headrests will be required in the target setting.

The clinical measuring tools for outcome evaluation are available. For the

measurement of oxygenation and chest infection, continuous patient’s pulse oximetry

monitoring, arterial blood gas analysis, patient’s clinical signs, ventilator setting and chest

radiography should be recorded routinely (Fernandez et al., 2008; Gattinoni et al., 2001;

Guerin et al., 2004; Guerin et al., 2013; Mancebo et al., 2006; Papazian et al., 2005; Robak et

al., 2011; Taccone et al., 2009; Voggenreiter et al., 2005). Daily blood test for clotting profile,

complete blood count, renal and liver function helps to monitor patient’s non-pulmonary

system failure (Gattinoni et al., 2001; Voggenreiter et al., 2005). Adverse events including

presence, site and severity of pressure sore, hemodynamic instability, unplanned extubation

or blockage of endotracheal tube should also be documented. Finally, the duration and

number of prone positioning and the mortality rate should be recorded for the efficacy of the

innovation.

31

3.3 Cost-Benefit Ratio of the Innovation

3.3.1 Patient’s potential risks and benefits

Although prone positioning is cost-effective, patients may encounter adverse events

such as facial edema and pressure sore formation. Also, devices such as central venous access

and tracheal tube may be displaced during the turning process. Since the selected studies

showed no significant results in adverse events, using protective pads and strengthening

nursing observation and their turning technique can solve them. Once patients develop

hemodynamic instability or arrhythmia, the innovation should be terminated.

Prone positioning improves patient’s oxygenation, so the ventilator setting can be

further weaned. The use of oxygen becomes less that prevents the occurrence of barotrauma

as well. The rate of VAP can be reduced by the drainage effect of secretions. Finally, the

mortality rate of ARDS patients can be decreased.

3.3.2 Potential risks and benefits towards staff and the setting

Prone positioning requires teamwork from different parties including MOs, nurses, and

PCAs. Team building will be encouraged through the cooperation. The workload of nurses

will not become heavier because the pressure sore observation and vital signs monitoring are

the same as current practice. Nurses will gain new knowledge and proning technique as well.

Staff development, morale and satisfaction will be enhanced if the innovation succeeds to

save patients’ lives.

32

3.3.3 Potential risks of maintaining current practices

The current treatment of ARDS only depends on the clinical judgment of MOs, patients

keep supine position and are turned laterally every two hours, and there is no formal

guideline of prone positioning for nurses and MOs. As a result, patients with ARDS will

ventilate difficultly, the ventilator setting and the chance of developing barotrauma will be

increased. The prognosis of the patients cannot be improved if the current practice is

maintained.

3.3.4 Potential material and non- material costs for implementation

As mentioned above, prone positioning is simple and the equipment needed is minimal.

Most equipment including pillows, routine laboratory tests and chest radiograph service are

available in the target setting. Only two extra manufactured prone headrests will be purchased

and no addition maintenance cost will be needed. Training workshop reduces nurses’ stress

related to unfamiliar tuning technique. However, extra time for nurse training is required. The

training handout will be uploaded to the department website. No extra printing cost will be

spent except a new guideline will be printed out and kept as reference in the target setting.

The cost in the long run prone positioning not only is minimal, it also saves much cost of the

outcome. The details of cost calculation are attached in Appendix 6.

In conclusion, prone positioning can be implemented in the target setting with limited

barriers after concerning the transferability, feasibility and cost-benefit ratio.

33

Chapter 4

Developing an Evidence Based Practice Guideline

An evidence-based guideline of prone positioning is established according to the

evidence from the selected studies in previous chapters.

4.1 Title of the Evidence-Based Practice Guideline

Evidence based guideline of prone positioning for adult patients with acute respiratory

distress syndrome in intensive care unit.

4.2 Aim of the Guideline

The aim of the innovation is to facilitate ventilation among ARDS patients by

increasing their oxygenation. It further decreases the prevalence of VAP and improves the

survival rate of patients.

4.3 Objectives of the Guideline

The objectives of this guideline are:

- To formulate clinical instructions for prone positioning based on the best evidence

based practice research,

- To strengthen nurses’ awareness and competence in performing prone positioning,

- To enhance nurses’ knowledge in prone positioning in evidence based approach.

4.4 Target Population

Patients who are 18 years old or above and suffer from ARDS.

34

4.5 Target Users of the Guideline

All nurses are working in Intensive Care Unit.

4.6 Grading Scheme of the Guideline

Regarding to “SIGN 50: a guideline developer’s handbook” (SIGN, 2012), the levels of

evidence are rated from 1++ to 4 and the grades of recommendation are presented as Grade A

to Grade D (Appendix 5).

4.7 Practice Recommendations

A number of recommendations for prone positioning are concluded based on the

evidences from nine selected studies. They are presented into four categories: (1) Assessment;

(2) Initiation and implementation of prone positioning; (3) Monitoring and evaluation and (4)

Termination (Appendix 7).

4.7.1 Assessment

Recommendation 1.1 (Grade A)

Patients who have severe hypoxemia with PaO2/FiO2 ratio < 150mmHg, FiO2 ≥ 0.6

and PEEP ≥ 5cm of water and require MV are benefit from prone positioning.


Patients are contraindicated for prone positioning if they have cerebral edema with

elevated intracranial pressure >30mmHg and cerebral perfusion pressure <60mmHg, unstable

fractures of pelvic, femur or spine, severe hemodynamic instability, pregnancy and elevated

35

intra-abdominal pressure.

4.7.2 Initiation and implementation of prone positioning


Prone positioning should be initiated within 36 hours upon ARDS diagnosis.


The duration of prone positioning should be at least 17hours/day.


Prone positioning should be continued at least 4 days.


Protective lung ventilation should be applied during prone positioning.


Protective pads should support patients’ forehead, chest, knees and iliac crests during

prone positioning.


Patients’ heads and necks should be turned laterally every two hours during prone

positioning.

4.7.3 Monitoring and evaluation


Physiological variables of patients should be continuously monitored and documented

36

just before prone positioning, 1 hour after prone positioning, just before turning back to

supine position and 4 hours later.


Nurse should monitor and record the presence of VAP.


Patients’ skin integrity should be observed every shift.

4.7.4 Termination


Prone positioning should be terminated if patients’ oxygenation improves or

deteriorates and major complication occurs.

37

Chapter 5

Implementation Plan

In previous chapters, an evidence-based guideline of prone positioning for adult

patients with ARDS is developed. A well-designed implementation schedule which includes a

clear communication plan with all stakeholders, staff training and a pilot study will be carried

out in the target ICU of a local public hospital in order to examine the effectiveness of

guideline.

5.1 Communication Plan with Potential Stakeholders

5.1.1 Identification of the stakeholders

A good communication among the stakeholders is crucial to the success of the

innovation implementation. For the prone positioning guideline, the potential stakeholders are

involved the administrators, managerial staffs, frontline staffs, supporting groups, patients

with ARDS and their relatives.

The administrators include Chief of Service (COS), DOM and Ward Manager (WM)

who are very important in approving the pilot study and the implementation of the proposed

guideline. They also provide financial support and other resources for the implementation.

The managerial staffs include Associated Consultants (ACs), NC and APNs who are

responsible for promoting evidence based practice in the target setting, monitoring and

managing the outcomes of the proposed guideline.

38

MOs, nurses and PCAs are the frontline staffs who are responsible for the patients in

prone position. MOs and nurses are responsible for the initiation and termination of the

innovation. Nurses also provide ongoing assessment and monitoring for the patients. PCAs

need to assist the nurses during proning procedure.

Supporting groups involve the staffs from laboratory and x-ray department. They are

required to provide efficient and precise laboratory tests and chest radiograph for the outcome

measurement.

5.1.2 The process of communication plan and implementation strategies

As mentioned above, a specific communication strategy will be developed to

appropriate stakeholders to gain their support. A core group of the proposed innovation will

be formed which consists of the proposer, one AC, one APN and two nurses from the target

setting. It will spend about two weeks to invite certain staffs to become core members. The

proposer will introduce the proposed guideline to the team via informal discussion.

Information regarding the affirming needs and significance of the change in current practice

and the evidence of prone positioning from the literature will be presented. When the core

group is formed, core members will approach different parties separately to promote the

innovation.

5.1.2.1 Initiating the proposed innovation

In order to obtain the approval and financial support in the target setting, a formal

39

meeting with the administrators will be held by core members. During the meeting, core

members will present the current practice, the changing needs and the significance of prone

positioning through PowerPoint and written proposal. The new prone positioning guideline

together with the current evidences will be introduced as well to provide a clear view of the

benefits for both patients and clinical setting. The details of the proposed innovation such as

the implementation potential, potential barriers, required resources and manpower will be

discussed. Several meetings will be held to receive their opinions, answer and further explain

their concerns. The estimated time of communication is about a month until the approval

gained.

5.1.2.2 Guiding the proposed innovation

After receiving the approval and resources, core members will promote the proposed

guideline to the other stakeholders in the next one and a half months.

The frontline staffs play an important role to implement the proposed guideline. For

instance, ACs and MOs are required to interpret the x-ray film, provide a precise diagnosis

for ARDS patient and treatments such as ventilator setting adjustment and medication

prescription. Information about the significance and benefits of prone positioning will be

promoted in a one-hour conference. Besides, the details of the guideline will be sent to their

internal e-mail accounts for reference.

For nurses’ training, a one-hour journal club will be held to explain the importance of

40

prone positioning by briefly sharing the research findings. Core members will introduce the

new evidence-based guideline and emphasize the nursing care such as continuous monitoring

and adverse events assessment of prone positioning. The PowerPoint presented in the journal

club will be posted on department website in the hospital intranet. A ‘read and sign’ approach

will be conducted to confirm all nurses recognize the new innovation before implementation

and the copy of the guideline will be kept in every bedside for reference.

As a special technique is required in proning procedure, a one-hour intensive workshop

will be organized every week to reinforce staffs’ skills. The workshop consists of hands-on

practice and return demonstration. Ten nurses will be trained each session and three sessions

will be needed to train up all nurses in the target department. During the training workshop,

the aims and evidence of proposed guideline will be emphasized again to facilitate their

compliance. Using ‘train-the-trainers’ method, all APNs and senior nurses will participate in

the workshop first and become the role models in the future. A guideline with photos about

the proning technique will be kept in the prone positioning folder.

PCAs and other supporting groups will bear comparatively less responsibilities in

implementation. PCAs will follow nurses’ instructions to perform proper proning preparation

and procedure. Since there will be no extra laboratory test nor x-ray for the innovation

evaluation, the guideline will be sent to the department heads via internal e-mail. Patients

recruited in the innovation are remained unconscious; a clear poster will be posted on the

41

notice board to promote the change to their relatives (Appendix 8).

5.2.1.3 Sustaining the proposed innovation

To ensure the success of the change, core members together with NC and all APNs will

provide with ongoing supports and knowledge, which can help to motivate the frontline staffs

to maintain the practice. APNs will monitor nurses’ compliance with the guideline and

patients’ outcomes through daily assessment. Audit team of the department will carry out

nursing audit every three months to evaluate nurses’ skills and care for patients in prone

position. Frontline staffs will give their feedbacks and express their difficulties in the

workshop, monthly ward meeting and weekly nursing grand round. After collecting their

feedbacks, core members will modify the guideline with updated evidence continuously.

5.2 Pilot Study to Try Out the Guideline

5.2.1 The objectives of pilot study

A six-month pilot study will be carried out in the target ICU before full implementation

for the following objectives: (1) to examine the feasibility of prone positioning for ARDS

patients in target ICU; (2) to collect data on outcome measures; (3) to monitor the

acceptability and the compliance with the proposed guideline among the frontline staffs and

patients; (4) to identify potential problems and difficulties during implementation; (5) to

revise the guideline including logistics and operational cost.

Besides, ethical approval is gained from the Hospital Research Ethic Committee before

42

its start. Nurses will explain the information regarding the pilot study to the patients and their

relatives, and obtain their informed consents at the same time.

5.2.2 Patient recruitment of pilot study

Patient recruitment criteria in the pilot study will be the same as the proposed guideline

mentioned and convenient sampling will be used. It is estimated that 15 eligible patients will

be recruited. APNs and core members will screen the eligible patients and seek ACs’ approval

to proceed to the innovation. They will also review the logistics of patient recruitment in

order to identify any difficulty and modify the strategies. With their experiences, nurses will

be trained to be competent in patient selection.

5.2.3 The new evidence based guideline of prone positioning

In the pilot study, nurses will provide prone positioning to the eligible patients. Nurses

with assistance of core members will do continuous assessment and monitoring of the

patients. Besides, they will document ventilator settings, laboratory results and any adverse

events, which show compliance of patients objectively.

5.2.4 Data collection for patient, staff and system outcomes

Oxygenation, which measures PaO2/FiO2 ratio, is considered as primary outcome.

Data including the laboratory results, ventilator settings and respiratory status of patients will

be recorded by nurses. Since patients are unconscious during prone positioning, their

compliance with the innovation will be reflected by objective adverse events such as

43

worsening ventilation. Patient progress review will be done by core members daily to

evaluate the outcomes.

To ensure sufficient knowledge and skills of nurses before the pilot study, those who

participated in the journal club and training workshops should complete the questionnaires at

the end of each session respectively (Appendices 9 & 10). Core members will receive their

comments and revise the training method in a short period. The compliance of nurses will be

assessed through their daily assessment and documentation. Besides, they will complete a

questionnaire, which evaluates their acceptance and job satisfaction at the end of the pilot

study (Appendix 11). Their concerns and difficulties encountered are very useful in revising

the guideline.

For the system outcome, the cost and material used in the pilot study will be estimated

for the budget plan of actual implementation.

5.2.5 Evaluation of pilot study

After collecting and analyzing the data from patients’ objective parameters,

questionnaires and feedbacks, the preliminary outcomes will be evaluated. The weakness and

limitations will be identified and discussed in the formal meeting among the core group. Core

members will review the proposed innovation and share the successful cases to the

stakeholders before the actual implementation.

44

Chapter 6

Evaluation Plan

The evaluation plan is established to assess the effectiveness and feasibility of

proposed guideline in the target ICU. Outcomes of the innovation will be identified and

evaluated after the full implementation. The results will be presented to the stakeholders in

order to determine whether the change is worthwhile to continue in the future.

6.1 Identify Outcomes to be Achieved

The outcomes of the proposed guideline consist of patient outcomes, healthcare

provider outcomes and system outcomes.

6.1.1 Patient outcomes

Clinical benefits of the innovation are primary focus of the patient outcomes. The

purpose of prone positioning is to enhance oxygenation for patients who suffered from ARDS.

Hence, the primary outcome is oxygenation. As previous chapter mentioned, PaO2/FiO2 ratio

was measured in the nine reviewed studies. When PaO2/FiO2 ratio increases significantly,

the guideline is considered as effective. PaO2/FiO2 ratio recorded during the implementation

will compare with the baseline information.

The secondary outcomes are the prevalence of VAP, the mortality rate and the presence

of adverse events.

45

6.1.2 Healthcare provider outcomes

In order to initiate and sustain the change successfully, the cooperation among the MOs,

nurses and PCAs is crucial. Since healthcare providers especially nurses are required certain

knowledge and specific technique to perform prone positioning, their implementation skills

and knowledge will be assessed. Besides, their job satisfaction, compliance with the guideline

and level of competence to implement the innovation will also be measured.

6.1.3 System outcomes

System outcome is an essential consideration for administrators whether approve for

the continuity of the innovation or not. For prone positioning guideline, cost-effectiveness

and manpower will be evaluated as well. The expenditures of the new materials, such as

manufactured prone headrests will be compared with the material used in usual practice.

Besides, the cost spent on holding the journal club or training workshop, paperwork such as

questionnaires and audit forms, and oxygen used in one patient will be counted. The

difference will be analyzed to show cost effectiveness.

6.2 Nature and Number of Clients to be Involved

The proposed innovation involves the ICU patients and frontline staffs. Patients who

are admitted to the ICU are under MV within 36 hours and suffer from ARDS with

PaO2/FiO2 ratio <150mmHg, FiO2 ≥ 0.6 and PEEP ≥5cm water. Those who have cerebral

edema, unstable fracture of pelvic, femur or spine, severe hemodynamic instability,

46

pregnancy or elevated intra-abdominal pressure are excluded due to patient safety and ethical

consideration.

Convenient sampling will be performed in patient recruitment. The sample size is

based on the primary outcome. Three reviewed studies were chosen for the calculation

(Fernandez et al., 2008; Robak et al., 2011; Voggenreiter et al., 2005). These studies showed

an increase of PiO2/FiO2 between 39mmHg and 75mmHg. Hence, an average 50mmHg

increase of PiO2/FiO2 is applied in the online sample size calculator (Lenth, 2006-9). Paired

t-test is performed. By taking a power of 80% at a significance level of 0.05, the estimated

patient number is 32.

For the frontline staffs, there are 23 registered nurses, seven APNs, three ACs, three

MOs and five PCAs in the target ICU are evaluated.

6.3 Data Collection, Time and Frequency of Taking Measurements

Patients’ demographic data, the cause of ARDS, ventilator settings, time from

intubation will be recorded when they are eligible to receive prone positioning. The results of

arterial blood gas (ABG), SOFA score (Vincent et al., 1996), SAPS II (Le Gall et al., 1993)

and time at first prone session started will be documented as baseline information. When the

innovation is started, patients’ physiological data including ABG, pulse oximetry and

ventilator setting are measured routinely before prone positioning, one hour after prone

positioning, before turning back to supine position and four hours later.

47

Chest radiography, blood for total white cell count (WCC) and tracheal aspirates for

microbiology test are taken routinely under MOs’ clinical judgment for diagnosis of VAP. The

positive findings are recorded. Whenever there is any adverse event, the reason of termination,

the duration and number of prone session should be documented as well. The mortality rate

will be monitored 28 days after prone positioning according to Guerin et al.’s study (2013).

These data are obtained from patient’s progress documentation.

Questionnaires using Five-Level Likert Scale design (Likert, 1932) are used to evaluate

healthcare provider outcomes. Healthcare staffs should complete the questionnaires before

and after the journal club and training workshops to evaluate their skills and knowledge

(Appendices 9 & 10). Besides, another set of questionnaire (Appendix 11) is completed every

three months so that the job satisfaction and the level of competence are assessed. The

department audit team evaluates the compliance of nurses to the proposed guideline every

three months. Healthcare staffs are allowed to express their concerns and difficulties directly

in weekly nursing grand round and monthly ward meeting.

At the end of the implementation period, core members can calculate the

cost-effectiveness and manpower. The cost will be reviewed annually, and a final report with

expenditures analysis will be submitted to the administrators.

48

6.4 Data Analysis

Data analysis of outcomes will be carried out by the Statistical Package for Social

Science (SPSS). Descriptive statistics will be used to summarize the characteristics of

patients, which include demographic data, the cause of ARDS, ventilator settings, time from

intubation, SOFA score and SAPS II.

A two-tailed paired t-test will be used to analyze the change of oxygenation and

adverse events at pre and post prone positioning. The results will be presented as mean±

standard deviation. Statistical significance will be set as p<0.05.The prevalence of VAP and

mortality rate will be analyzed by performing a two-tailed z-test for one proportion. The data

will be compared to the baseline statistics.

For healthcare provider outcomes analysis, quantitative data from the questionnaires

will be analyzed by paired t-test and presented as mean±standard deviation. The main idea of

qualitative data obtained from the questionnaires and the meetings will be grouped into key

theme. Different views and experiences will be identified in each key theme and their

structural meanings will be explored.

6.5 Criteria of an Effective the Guideline

The guideline of prone positioning is considered as effective if the primary outcome is

achieved. In the review studies, PaO2/FiO2 ratio was reported to significantly increase by

21mmHg to 75mmHg at Day 4 after prone positioning (Fernandez et al., 2008; Guerin et al.,

49

2004; Guerin et al., 2013; Mancebo et al., 2006; Voggenreiter et al., 2005). Hence, the clinical

effectiveness for this study is quantified as a 40mmHg increase in PaO2/FiO2 ratio at Day 4

of the intervention.

For other secondary outcomes, the expected clinical effectiveness is quantified based

on the reviewed studies. The prevalence of VAP was reduced by 3.5% to 27% (Guerin et al.,

2004; Voggenreiter et al., 2005) and so a 15% reduction is regarded as effective. The

mortality rate was dropped by 8.3% to 16.8% at Day 28 after prone positioning (Fernandez et

al., 2008; Guerin et al., 2013; Robak et al., 2011; Voggenreiter et al., 2005). Hence, a 12%

drop in mortality at Day 28 is regarded as effective. For adverse events, since insignificant

results showed in four reviewed studies (Gattinoni et al., 2001; Guerin et al., 2013; Mancebo

et al., 2006; Voggenreiter et al., 2005), no significant result in adverse events is regarded as

effective.

With regards to the healthcare provider outcomes, job satisfaction, level of competence,

knowledge and skills are expected more than 70% to be graded at least three or above out of

five after implementation. The attendance of the journal club or workshop should be more

than 80%.

For the system outcome, the actual expenditures are expected not exceed the funding

by the department. Manpower and materials are expected to be sufficient during

implementation.

50

Chapter 7

Conclusion

ARDS is common and life-threatening condition developed in critically ill patients. It

is found prone positioning is a simple, safe and inexpensive method to improve oxygenation

and benefit on survival among ARDS patients. A systematic search was done, nine

randomized controlled trials were selected and critical appraised. After summarizing and

synthesizing the evidence, an early, continuous and prolonged prone positioning was proved

effective and was translated to the practice.

Considering the implementation potential including the transferability, the feasibility

and cost-effectiveness of the innovation to the target setting and audience in local ICU, an

evidence-based guideline of prone positioning for ARDS patients is developed.

Implementation plan requires an effective communication strategy to different

stakeholders. Besides, staff training towards the guideline and a six-month pilot study will be

carried out to test the feasibility before full implementation.

The outcomes of patients, healthcare providers and system will be evaluated after

implementation. The primary outcome of the innovation is oxygenation. A 40mmHg increase

in PaO2/FiO2 at Day 4 of the intervention will be regarded as effective.

51

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57

Appendix 1 Search Strategies

PubMed (1997-2013), Medline (ProQuest, 1991-2013, CINAHL (EBSCO host, 1991-2013)

Database

# Keyword search Pubmed Medline

(ProQuest)

CINAHL

(EBSCO host)

1 ARDS patients OR acute respiratory distress

OR acute respiratory distress syndrome OR

acute respiratory failure OR early acute

respiratory distress syndrome

36,989 14,193 4,071

2 Prone position OR prone positioning OR

prone position ventilation

45,359 49,029 837

3 Oxygenation OR oxygen consumption OR

oxygen saturation OR ventilation perfusion

ratio OR breathing

372,093 101,362 1582

4 #1 AND #2 AND #3 510 282 160

5 Subtotal 952

6 #1 AND #2 AND #3 (RCT) 33 20 44

7 Articles remained after screening title,

abstract and full paper

10 5 5

8 Articles remained after removal of duplicated

with other databases

6 3 0

9

Articles from references of eligible studies 0

Studies met the selection criteria 9

Systematic searching was performed in August, 2013

58

Appendix 2 Table of Evidence

1 Gattinoni, L., Tognoni, G., Pesenti, A., Taccone, P., Mascheroni, D., Labarta, V. et al. (2001). Effect of prone positioning on the survival of

patients with acute respiratory failure. The New England Journal of Medicine, 345(8), 568-573. Citation Study

type

Evidence

level

Patient characteristics Intervention(s) Comparison

/ Control

Outcome measures Effect size

Gattinoni

et al.,

2001

RCT 1+ ARDS or ALI patients who were received MV

from December 1996 to October 1999 in Italy

and Switzerland.

Age: mean 58

Male: 70%

BMI: not mentioned

SAPS II: mean 40, SOFA: not mentioned

ALI: 6%, ARDS: 94%

Pneumonia:48 %, Aspiration: 3%,

Sepsis: 9.3% Trauma: 2.3 %, Other:12%

PaO2/ FiO2 ratio: mean 127

PEEP, cm H2O: mean 9.6

FiO2: mean 0.73

PaO2, mmHg: mean 87

PaCO2, mmHg: mean 45

Prone position for

a mean of 7 h/day

for a period of 10

days

(n=152)

Supine

position

(n=152)

Primary outcome:

1) Mortality at 10 days,

2) the time of discharge

from ICU, and 6 months

after randomization.

Secondary outcome:

3) Improvement of

respiratory failure

4) Improvement of organ

dysfunction at 10 days.

5) No. of new/ worsening

sore

6) Complication ( tracheal

tube displacement, loss of

venous access, accidental

extubation, facial edema)

1) -3.9% (21.1% vs.

25%, RR= 0.84,

95%CI= 0.56-1.27,

p=0.65)

2) ns

3) PaO2/ FiO2 ratio

+18.4 (63 vs. 44.6,

p=0.02)

4) ns

5) +0.8 (2.7vs. 1.9,

p=0.004)

6) ns

59

2 Guerin, C., Gailard, S., Lemasson, S., Ayzac, L., Girard, R., Beuret,. P. et al. (2004). Effects of systematic prone positioning in hypoxemic

acute respiratory failure. JAMA, 292(19), 2379-2387.

Citation Study

type

Evidence

level

Patient characteristics Intervention(s) Comparison/

Control


Guerin et

al., 2004

RCT 1+ Adult patients with hypoxemic

ARF who were intubated over

48 hours were receiving MV

from December 1998 to

December 2002 in France.

Age: mean 62

Male: 75%

BMI: 26.2

SAPS II : mean 46




Prone position for

median of 8h/day for a

median of 4 days

(n=413)

Mean time between

ICU admission and

randomization was 58h.

Mean time between

randomization and first

prone session was 4.3h.

Supine position with

30° angle

(n=378)

Allow cross over to

prone position with

PaO2/ FiO2 ratio

<100 for more than

12 hours or <60 for

more than 1 hour,

both receiving pure

oxygen.

Primary outcome:

1) Mortality at 28 days

Secondary outcome:

2) Mortality at 90 days

3) Incidence of VAP

4) Duration of MV

5) PaO2/FiO2 ratio

6) Complication

(selective

intubation,

endotracheal tube

obstruction,

pressure sore)

1) -0.9 % ( 31.5% vs. 32.4%,

RR= 0.97,

95% CI= 0.79-1.19,

p= 0.77)

2) – 1.1% (42.2%vs. 43.3%,

RR= 0.98,

95% CI: 0.84-1.13, p= 0.74)

3) -3.5% (20.6% vs. 24.1%,

p=0.045)

4) ns

5) p=<0.001

6) p=0.01, p=0.002, p=0.005

No protective lung ventilation

Crossover was allowed only in cases of

life-threatening hypoxemia.

60

3 Papazian, L., Gainnier, M., Marin, V., Donati, S., Arnal, J.M., Demory, D. et al. (2005). Comparison of prone positioning and

high-frequency oscillatory ventilation in patients with acute respiratory distress syndrome. Critical Care Medicine, 33(10), 2162-2171. Citation Study

type

Evidence

level


Control


Papazian

et al.,

2005

RCT 1- Adult patients with ARDS

received MV in France

Age: mean 51

Male :59%

BMI: not mentioned

SAPS II score: mean 41

SOFA: mean 9.5

ARDS due to pneumonia:40%

Sepsis: 13%, Aspiration: 36%

PaO2/FiO2 ratio: mean 103

PEEP, cm H2O: mean 11

FiO2: mean 0.72

PaO2, mmHg: not mentioned

PaCO2, mmHg: mean not

mentioned

After an optimizations period (supine-CV)

of 12 hours using conventional lung

protective mechanical ventilation, patients

were assigned to following groups:

1) PaO2/FiO2 ratio

2) Hemodynamic

variables and

gaseous

exchange

1) Group A vs. supine-CV(baseline)

+79 (217 vs. 138, p<0.0001)

Group B vs. supine-CV

+101 (227 vs. 126, p<0.0001 )

Group C vs. supine-CV : ns

2) Prone position group reduced the

venous admixture than supine group.

(p<0.05).

Group A:

Conventional

lung-protective

mechanical ventilation in

prone position

(prone-CV) for 12 hours

(n=13)

Group B:

HFOV in prone position

for 12 hours

(prone-HFOV) (n=13)

Group C:

HFOV in

supine position

for 12 hours

(supine-HFOV)

(n=13)

61

4 Voggenreiter, G., Aufmkolk, M., Stiletto, R.J., Baacke, M.G., Waydhas, C., Ose, C et al. (2005). Prone positioning improves oxygenation in

post-traumatic lung injury- a prospective randomized trial. The Journal of Trauma, 59(2), 333-343. Citation Study

type

Evidence

level

Patient characteristics Intervention(s) Comparison

/ Control

Outcome measures Length

of

study

Effect size

Voggenreiter

et al., 2005

RCT 1+ Multiple trauma adult patients

associated with ALI or ARDS

who received MV from

September 1999 to September

2001in Germany.

Age: mean 42

Male: 83%

BMI: not mentioned

ISS: mean 37, SOFA Score: 12

ALI: 55%, ARDS: 45%

Pneumonia:18 %, Sepsis: 3%



FiO2: mean 0.49

PaO2, mmHg: mean 104


Prone position during

nighttime until PaO2/

FiO2 ratio >300 in prone

and supine 48 hours.

Prone position was

applied for a mean of

11h/ day.

(n=21)

Supine

position

(n=19)

Primary outcome:

1) Duration of MV

Secondary outcome:

2) Days with ARDS

and ALI

3) Days with LIS >=2

4) PaO2/ FiO2 ratio

5) Sepsis,

6) Prevalence of

pneumonia

7) Prevalence of ARDS

8) Mortality

9) Complication

( pressure sore,

edema, tracheal tube

displacement,

arrhythmia)

10) PEEP Day 4

11) Packed cell

transfusion

12) Use of antibiotic and

paralyzing agent

90days 1) ns

2) ARDS: ns

ALI: -3 days (8 vs. 11,

p= 0.03)

3) ns

4) +44.1 (71.8 vs. 27.7,

p=0.03 in first 4 days )

5) ns

6) -27% (62% vs. 89%,

p=0.048)

7) -6 (6 vs. 12, p=0.03)

8) -11% (5% vs. 16%,

p=0.27), due to small

sample size.

9) ns

10) p<0.009

11) -18.7 (9.5 vs. 28.2 unit

p=0.05)

12) ns.

The mean time between trauma and

entrance into the study was 5 days.

No crossover was allowed.

Protective lung ventilation was applied.

No PEEP algorithm protocol.

62

5 Mancebo, J., Fernandez, R., Blanch, L., Rialp, G., Gordo, F., Ferrer, M. et al. (2006). A multicenter trial of prolonged prone ventilation in

severe acute respiratory distress syndrome. American Journal of Respiratory and Critical Care Medicine, 173, 1233-1239. Citation Study

type

Evidence

level


Control


Mancebo

et al.,

2006

RCT 1+ Severe ARDS patients as defined

by the American-European

Consensus Conference from

December 1998 to September 2002

in Spain and Mexico.

Age: mean 54

Male: 58%

BMI: not mentioned

SAPS II: mean 41

SOFA: not mentioned

ARDS due to pneumonia:50.7 %

Aspiration: 11%, Sepsis: 23.5%

Trauma: 2.2 %, Other: 12.5%

PaO2/ FiO2 ratio: mean 146.5


FiO2: mean 0.82

PaO2, mmHg: mean 116.5


Prone position within

1h after randomization

until weaning

oxygenation threshold

was reached, then

turned to supine for up

to 4 hours each

morning.

Prone position was

applied for a mean of

17h/ day with average

10 day.

(n=80)

Supine position

(n=62)

Primary outcome:

1) ICU mortality

Secondary outcome:

2) Hospital mortality

3) Associated

complications

( edema,

conjunctival

hemorrhage and

pressure sore)

4) Length of stay

5) PaO2/ FiO2 ratio

6) FiO2

Day 4

7) Plateau pressure,

8) PEEP

1) -15% absolute, -25% relative

(43% vs. 58%, p=0.12) (due

to higher severity score in

prone group)

2) -12 % (50 vs. 62, p=0.27)

3) ns

4) ns

5) Day 4

+39 (215 vs. 176, p<0.005)

6) Day 4

-10 % (52%vs.62%, p<0.001)

7) -3 (31 vs. 28 cm H2O,

p=0.01)

8) -2 (11vs. 9 cm H2O,

p= 0.048)

Time between ARDS diagnosis and

randomization was 1.04 day in supine group

and 0.89 day in prone group.

Crossover was allowed.


63

6 Fernandez, R., Trenchs, X., Klamburg, J., Castedo, J., Serrano, J.M., Besso, G. et al. (2008). Prone positioning in acute respiratory distress

syndrome: a multicenter randomized clinical trial. Intensive Care Medicine, 34, 1487-1491. Citation Study

type

Evidence

level


Control


Fernandez

et al.,

2008

RCT 1+ ARDS patients as defined by the

American- European Consensus

Conference in September 2003 in

Spain.

Age: mean 54.6

Male: 63%

BMI: not mentioned

SAPS II: mean 38.3

SOFA: mean 9.25

Lung Injury score: mean 3.1

PaO2/ FiO2 ratio: mean 155.5


FiO2: mean 0.75

PaO2, mmHg: mean 112.4

PaCO2, mmHg: mean 49.4

Prone position maintained

up to 20h/day within 48h

after diagnosis. Then,

turned supine when

oxygenation improved for

longer than 12h. (i.e.

PaO2/ FiO2 ratio higher

than 250 at PEEP of 8cm

H2O or lower.

(n=21)

Supine position

(n=19)

Primary outcome:

1) PaO2/ FiO2 ratio

2) 60-day mortality.

Secondary outcome:

3) Length of mechanical

ventilation

4) Length of ICU stay

5) Use of vasoactive

drug and sedation

1) + 75 on Day 3 (234±85 vs.

159±78, p=0.009).

2) -15% (38% vs. 53%), but no

significant difference due to

small sample size.

3) -3.8 day ( 11.9 vs. 15.7,

p=0.5)

4) -2.8day ( 14.7 vs. 17.5,

p=0.5)

5) ns Protective lung ventilation was applied

Crossover was allowed only in cases of

life-threatening hypoxemia after 6h in position

selected.

64

7 Taccone, P., Pesenti, A., Latini, R., Polli, F., Vagginelli, F., Mietto, C. et al. (2009). Prone positioning in patients with moderate and severe

acute respiratory distress syndrome. JAMA, 302(18), 1977-1984. Citation Study

type

Evidence

level


Control


Taccone

et al.,

2009

RCT 1+ ARDS patients as defined by

American-European Consensus

Conference criteria in Italy and Spain

from February 2004 to June 2008;

Age: mean 60

Male: 71.3%

BMI: 25.3

SAPS II: mean 41

SOFA: mean 6.8

ARDS due to pneumonia: 59.1 %

Aspiration: 6.4%, Sepsis: 4.7%

Trauma: 1.8 %, Other: 23.4%



FiO2: mean 0.72

PaO2, mmHg: not mentioned.

PaCO2, mmHg: mean 46.5

Prone position after

diagnosed ARDS within

72 hours until the

resolution of acute

respiratory failure or end

of the 28-day study

period.

average 8 sessions per

patient, mean duration per

session was 18 hours

(n= 168)

Supine position

(n= 174)

Primary outcome

1) Mortality at day 28

Secondary outcome


3) SOFA score at day 28

4) Ventilator free days

5) Complication (use of

sedation, muscle

paralysis,

hemodynamic

instability or device

displacement

Moderate ARDS:

1) +3% (25.5 vs. 22.5%,

RR=1.04, 95%CI=

0.89-1.22, p= 0.62)

2) -1.3% (42.6% vs. 43.9%,

RR= 0.98, 95%CI=

0.76-1.25, p= 0.85)

3) ns

4) ns

Severe ARDS:

1) -8.3% (37.8% vs. 46.1%,

RR=0.87, 95%CI=

0.66-1.14, p= 0.631)

2) -10.5% (52.7% vs. 63.2%,

RR=0.78, 95%CI=

0.53-1.14, p= 0.19)

3) ns

4) ns

5) 18.2% (94.6% vs. 76.4%,

p<0.001)


Crossover was allowed only as a rescue

measure.

65

8 Robak, O., Schellongowski, P., Bojic, A., Laczika, K., Locker, G.J. & Staudinger, T. (2011). Short-term effects of combining upright and

prone positions in patients with ARDS: a prospective randomized study. Critical Care, 15. Citation Study

type

Evidence

level


Control


Robak et

al., 2011

RCT 1- Patients ventilated for ALI or ARDS that

were defined by American-European

Consensus Conference from October 2008

to April 2010 in Austria. .

Age: mean 67

Male :35%

BMI: not mentioned

SAPS II: mean 52

LIS: mean 3

ARDS due to pneumonia:75%

Sepsis: 20%, Vasculitis: 5%



FiO2: mean 0.7

PaO2, mmHg: not mentioned


Group A

PP for 2 hours.

Then, PP+UP for 6

hours (total 8h)

(n=9)

Group B

PP+UP for 2 hours.

Then, PP for 6

hours. (total 8h)

(n=11)

Primary outcome:

1) PaO2/ FiO2 ratio.

Secondary outcome:

2) Changes in PaCO2

3) Compliance of lung,

chest wall and

respiratory system.

1)In group A,

PP+UP 2h vs. supine:+56,

p=<0.05

In group B,

PP+UP 2h vs. supine: +55,

p<0.001.

2) ns

3) ns


66

9 Guerin, C., Reignier, J., Richard, J.C., Beuret, P., Gacouin, A., Boulain, T. et al. (2013). Prone positioning in severe acute respiratory

distress syndrome. The New England Journal of Medicine, 368 (23), 2159-2168. Citation Study

type

Evidence

level


Control


Guerin

et al.,

2013

RCT 1++ ARDS patients as defined by

American-European

Consensus Conference criteria

in France and Spain from

January 2008 to July 2011;

MV for ARDS <36 hrs;

Severe ARDS

Age: mean 59

Male : 68.2%

BMI: mean 28.5

SAPS II: mean 46

SOFA: mean 10

ARDS due to

pneumonia:60.3%



FiO2: mean 0.79

PaO2, mmHg: mean 80


Prone position with guidelines within

first hour after randomization until

improvement in oxygenation.

.

(First prone within 55mins after

randomization, average 4 sessions per

patient, mean duration per session

was 17 hours.)

(n=237)

Supine group

remained in a

semi-recumbent

position.

(n=229)

Primary outcome


Secondary outcome


3) Successful extubation

rate at day 90

4) LOS in ICU at day 90

5) Complications

6) Use of NIV

7) Tracheotomy rate

8) PaO2/FiO2

9) PEEP

10) FiO2

1) -16.8% (16% vs.

32.8%, HR= 0.39,

p<0.001)

2) –17.4% (23.6% vs.

41%, HR= 0.44,

p<0.001)

3) +20.5% (80.5% vs.

65%, HR= 0.45,

p < 0.001)

4) p=0.05, ns

5) p=0.85, ns

6) p> 0.05, ns

7) p>0.05, ns

8) Day 3 +15

(172vs.157, p<0.05)

Day 5 +22

(179vs. 157, p<0.01)

9) Day 3 -0.7, p<0.05

Day5 -0.8, p<0.05

10) Day 3 -0.05, p<0.01

Day 5 -0.07, p<0.01

MV in VC mode with constant inspiratory flow, with

tidal volume targeted at 6ml/kg and PEEP level selected

from a PEEP-FiO2 table.


Crossover was allowed only as a rescue measure.

67

Appendix 3 Critical Appraisal of Each Study by SIGN

S I G N

Methodology Checklist : Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Gattinoni, L., Tognoni, G., Pesenti, A., Taccone, P., Mascheroni, D., Labarta, V. et al. (2001). Effect of prone positioning on the

survival of patients with acute respiratory failure. The New England Journal of Medicine, 345(8), 568-573.

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes.

The study determined the effect of prone

positioning on the survival of patients with

ARL or ARDS.

1.2 The assignment of subjects to treatment groups is randomised.

Yes.

Randomization was done centrally by

telephone on a 24-hour-a-day,

7-day-a-week basis and was based on a

permuted-block algorithm.

1.3 An adequate concealment method is used.

Yes.

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Can’t say. The study didn’t mention.

1.5 The treatment and control groups are similar at the start of the trial. Yes. No p-value shown, claimed

insignificance.

1.6 The only difference between groups is the treatment under investigation. Yes.

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes.

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was completed?

Not mentioned.

1.9 All the subjects are analysed in the groups to which they were randomly

allocated (often referred to as intention to treat analysis)

Yes.

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes.

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Acceptable (+)

2.2 Taking into account clinical considerations, your evaluation of the methodology used,

and the statistical power of the study, are you certain that the overall effect is due to the

study intervention?

Yes.

Small number of patients than

planned.

2.3 Are the results of this study directly applicable to the patient group targeted by this

guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to

which it answers your question and mention any areas of uncertainty raised above.

Prone position improves arterial oxygenation and has a limited complication. Prone position might useful for

patient with severe hypoxemia.

68

S I G N



Guerin, C., Gailard, S., Lemasson, S., Ayzac, L., Girard, R., Beuret,. P. et al. (2004). Effects of systematic prone positioning in

hypoxemic acute respiratory failure. JAMA, 292(19), 2379-2387.



1.1 The study addresses an appropriate and clearly focused

question.

Yes.

The study determined the effect of prone position in

patients with acute respiratory failure.

1.2 The assignment of subjects to treatment groups is

randomised.

Yes.

Computer-generated random sequence was used.


Yes.

Sealed opaque envelopes were used.

1.4 Subjects and investigators are kept ‘blind’ about

treatment allocation.

No.

Unblind. Data collected and outcomes assessors were not

blinded.

1.5 The treatment and control groups are similar at the start

of the trial.

Yes.

No p-value shown, claimed insignificance.

1.6 The only difference between groups is the treatment

under investigation.

Yes.

1.7 All relevant outcomes are measured in a standard, valid

and reliable way.

Yes.

1.8 What percentage of the individuals or clusters recruited

into each treatment arm of the study dropped out before

the study was completed?

Intervention group: 1%; Control group : 2.6%

1.9 All the subjects are analysed in the groups to which they

were randomly allocated (often referred to as intention to

treat analysis).

Yes.

1.10 Where the study is carried out at more than one site,

results are comparable for all sites.

Yes.



2.2 Taking into account clinical considerations, your evaluation of the methodology used, and

the statistical power of the study, are you certain that the overall effect is due to the study

intervention?

Yes.


guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which

it answers your question and mention any areas of uncertainty raised above.

Prone positioning in patients with hypoxemia acute respiratory failure demonstrated improved oxygenation and a

lower incidence of ventilator acquired pneumonia but significant harmful effect and no mortality benefit.

69

S I G N



Papazian, L., Gainnier, M., Marin, V., Donati, S., Arnal, J.M., Demory, D. et al. (2005). Comparison of prone positioning and

high-frequency oscillatory ventilation in patients with acute respiratory distress syndrome. Critical Care Medicine, 33(10), 2162-2171.




question.

Yes.

The study was to compare the effects of prone position, HROV,

and their combination on gas exchange in severe ARDS

patients.


randomised.

Can’t say.

Randomization mentioned without method specified


Yes.

Opaque, sealed envelopes were used.



Can’t say. Not mentioned.


of the trial.

Yes. No p-value shown, claimed insignificance.



Yes.


and reliable way.

Yes.




Not mentioned.

1.9 All the subjects are analysed in the groups to which

they were randomly allocated (often referred to as

intention to treat analysis).

Does not apply.

All the subjects were analyzed as no drop out was mentioned.



Does not apply.

This is a single-centered study carried out in a medical ICU.


2.1 How well was the study done to minimise bias? Low quality (-)

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the

statistical power of the study, are you certain that the overall effect is due to the study

intervention?

Yes

Not clear randomization.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes



In ARDS patients, HFOV in the supine position does not improve oxygenation and reduces lung inflammation,

prone-HFOV produced improvement in oxygenation in oxygenation that was similar to that of prone-CV but was

higher BALF indexes of inflammation.

70

S I G N



Voggenreiter, G., Aufmkolk, M., Stiletto, R.J., Baacke, M.G., Waydhas, C., Ose, C et al. (2005). Prone positioning improves

oxygenation in post-traumatic lung injury- a prospective randomized trial. The Journal of Trauma, 59(2), 333-343.




question.

Yes.

The study determined the effect of prone positioning

on the duration of mechanical ventilation in multiple

trauma patients with ALI or ARDS.


Yes.

Randomization was done centrally by telephone on a

24-hour-a-day, 7-day-a-week basis and was based on

a permuted-block algorithm.


Yes.

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Can’t say. The study didn’t mention.

1.5 The treatment and control groups are similar at the start of the

trial.

Yes. p-value > 0.05

1.6 The only difference between groups is the treatment under

investigation.

Yes.

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes.

1.8 What percentage of the individuals or clusters recruited into

each treatment arm of the study dropped out before the study

was completed?

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat

analysis).

Yes.

1.10 Where the study is carried out at more than one site, results

are comparable for all sites.

Yes.





intervention?

Yes.

Small sample size.

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline? Yes.



Intermittent prone positioning did not reduce the duration of mechanical ventilation with limited number of

patients. Oxygenation improved significantly over first 4 days of treatment, the prevalence of ARDS and

pneumonia was reduced.

71

S I G N



Mancebo, J., Fernandez, R., Blanch, L., Rialp, G., Gordo, F., Ferrer, M. et al. (2006). A multicenter trial of prolonged prone ventilation

in severe acute respiratory distress syndrome. American Journal of Respiratory and Critical Care Medicine, 173, 1233-1239.




Yes.

The study determined whether prone ventilation

can decrease mortality in the course of ARDS.

1.2 The assignment of subjects to treatment groups is randomised. Yes.



Yes.

Sealed opaque envelopes were used.

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Can’t say.

The study didn’t mention.

1.5 The treatment and control groups are similar at the start of the trial. Yes.

p-value > 0.05


investigation.

Yes.

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes.


treatment arm of the study dropped out before the study was

completed?

Intervention group: 2.5%; control group: 3.2%


randomly allocated (often referred to as intention to treat analysis).

Yes.



Yes.



2.2 Taking into account clinical considerations, your evaluation of the methodology

used, and the statistical power of the study, are you certain that the overall effect

is due to the study intervention?

Yes.

The study was stopped due to decreased

patient accrual and was underpowered.

2.3 Are the results of this study directly applicable to the patient group targeted by

this guideline?

Yes.



Prone ventilation is feasible and safe, and may reduce mortality in patient with severe ARDS when it is initiated early

and applied for most of the day. The study conducted a good randomization. Blinding to patient is difficult to proceed.

72

S I G N



Fernandez, R., Trenchs, X., Klamburg, J., Castedo, J., Serrano, J.M., Besso, G. et al. (2008). Prone positioning in acute respiratory

distress syndrome: a multicenter randomized clinical trial. Intensive Care Medicine, 34, 1487-1491.




question.

Yes.

The objective of the study was to examine the effect

on survival of prone positioning in ARDS patients.


Yes.



Yes.

Centralized call centre

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Can’t say. The study didn’t mention.

1.5 The treatment and control groups are similar at the start of the

trial.

Yes.

p-value > 0.05


investigation.

Yes.

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes.

1.8 What percentage of the individuals or clusters recruited into

each treatment arm of the study dropped out before the study

was completed?

Intervention group: 8.7% ; Control group: 0%


randomly allocated (often referred to as intention to treat

analysis).

No. The study didn’t mention.



Yes.



2.2 Taking into account clinical considerations, your evaluation of the

methodology used, and the statistical power of the study, are you

certain that the overall effect is due to the study intervention?

Yes.

The study conducted with low recruitment of

patient. Low statistic power due to small sample

size.

2.3 Are the results of this study directly applicable to the patient group

targeted by this guideline?

Yes.



Early continuous prone positioning benefit on survival in ARDS patients. The study conducted a good

randomization. Blinding to patient is difficult to proceed.

73

S I G N



Taccone, P., Pesenti, A., Latini, R., Polli, F., Vagginelli, F., Mietto, C. et al. (2009). Prone positioning in patients with moderate

and severe acute respiratory distress syndrome. JAMA, 302(18), 1977-1984.




Yes.

The study assessed the benefits of prone

positioning in patients with moderate and

severe hypoxemia who are affected by ARDS.


Yes.

Computer-generated random sequence was

used.


Yes.

Allocation was done centrally by telephone on

a 24-hour-a-day, 7-day-a-week basis and was

based on a permuted-block algorithm.

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Yes.

Only investigators were blinded.

1.5 The treatment and control groups are similar at the start of the trial. Yes. No p-value shown.


investigation.

Yes

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes


treatment arm of the study dropped out before the study was

completed?

Intervention group: 1.2%, Control group: 1.1%.


randomly allocated (often referred to as intention to treat analysis).

Yes.



Yes.



2.2 Taking into account clinical considerations, your evaluation of the methodology used,

and the statistical power of the study, are you certain that the overall effect is due to the

study intervention?

Yes.


guideline?

Yes.



Prone positioning doesn’t provide significant survival benefit in patients with ARDS or in subgroups with moderate

and severe hypoxemia.

74

S I G N



Robak, O., Schellongowski, P., Bojic, A., Laczika, K., Locker, G.J. & Staudinger, T. (2011). Short-term effects of combining

upright and prone positions in patients with ARDS: a prospective randomized study. Critical Care, 15.




Yes.

The study evaluated the effect of

combining upright and prone position on

gas exchange in patients with ALI or

ARDS.


Can’t say.

Randomization mentioned without method

specified.


Yes.

Sealed envelopes were used.

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation. Can’t say. Not mentioned.

1.5 The treatment and control groups are similar at the start of the trial. Yes. No p-value shown, claimed

insignificance.

1.6 The only difference between groups is the treatment under investigation. Yes.

1.7 All relevant outcomes are measured in a standard, valid and reliable way. Yes.


treatment arm of the study dropped out before the study was completed?

Not mentioned.

1.9 All the subjects are analysed in the groups to which they were randomly

allocated (often referred to as intention to treat analysis).

Does not apply.

All the subjects were analyzed as no drop

out was mentioned.



Does not apply.

This is a single-centered study carried out

in a medical ICU.


2.1 How well was the study done to minimise bias? Low quality (-)



intervention?

Yes.

Not clear

randomization.




Combining the prone position with the upright position with ALI or ARDS patients leads to further improvement

of oxygenation.

75

S I G N



Guerin, C., Reignier, J., Richard, J.C., Beuret, P., Gacouin, A., Boulain, T. et al. (2013). Prone positioning in severe acute

respiratory distress syndrome. The New England Journal of Medicine, 368 (23), 2159-2168.




question.

Yes.

They study evaluated the effect of prone position on

outcomes in patients with severe ARDS.


randomised.

Yes.


1.3 An adequate concealment method is used. Yes.

Centralized web based management system.



Yes.

Outcome assessor blinded.


of the trial.

Yes. No p-value shown, claimed insignificance.



Yes


and reliable way.

Yes.




0%

1.9 All the subjects are analysed in the groups to which they

were randomly allocated (often referred to as intention to

treat analysis).

Yes.



Yes.


2.1 How well was the study done to minimise bias? High quality (++)



intervention?

Yes.




Patients with ARDS and severe hypoxemia can benefit from prone treatment when it is used early and in relatively

long sessions.

76

Appendix 4 Summary of Critical Appraisal

Y=Yes , N=No, CS= Can’t say, NA= Does not apply, NM= Not mentioned

1 Gattinoni

et al 2001

2 Guerin et

al. 2004

3 Papazian

et al, 2005

4

Voggenieter

et al. 2005

5 Mancebo

et al. 2006

6 Fernandez

et al. 2008

7 Taccone et

al 2009

8 Robak et

al. 2011

9 Guerin et

al. 2013

1.1 Y Y Y Y Y Y Y Y Y

1.2 Y Y CS Y Y Y Y CS Y


1.4 NM N NM NM NM NM Y NM Y




1.8 NM 1%; 2.6% NM 0% 2.5%; 3.2% 8.7%; 0% 1.2%; 1% NM 0%

1.9 Y Y NA Y Y NM Y NA Y

1.10 Y Y NA Y Y Y Y NA Y

2.1 + + - + + + + - ++



77

Appendix 5 Grades of Recommendations

Grade of Recommendations (Scottish Intercollegiate Guideline Network, 2012)

LEVELS OF EVIDENCE

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low

risk of bias

1+ Well-conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias

1- Meta-analyses, systematic reviews, or RCTs with a high risk of bias

2++ High quality systematic reviews of case control or cohort or studies

High quality case control or cohort studies with a very low risk of confounding or

bias and a high probability that the relationship is causal

2+ Well-conducted case control or cohort studies with a low risk of confounding or

bias and a moderate probability that the relationship is causal

2- Case control or cohort studies with a high risk of confounding or bias and a

significant risk that the relationship is not causal

3 Non-analytic studies, e.g. case reports, case series

4 Expert opinion

GRADES OF RECOMMENDATIONS

At least one meta-analysis, systematic review, or RCT rated as 1++, and directly

applicable to the target population; or

A body of evidence consisting principally of studies rated as 1+, directly applicable to the

target population, and demonstrating overall consistency of results

A body of evidence including studies rated as 2++, directly applicable to the target

population, and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 1++ or 1+

A body of evidence including studies rated as 2+, directly applicable to the target

population and demonstrating overall consistency of results; or

Extrapolated evidence from studies rated as 2++

Evidence level 3 or 4; or

Extrapolated evidence from studies rated as 2+

78

Appendix 6 Cost-Benefit Ratio for the Innovation

Material and non-material cost for the innovation

Items Estimated unit Unit price

(HKD)

Total price

(HKD)

1. Manufactured prone head rest 2 1,304 2,608

2. Color printing and photocopying

(Guideline)

20 pages 3 60

3. Extra training time for one- hour

workshop *

(use Point 20 as reference)

31 nurses 177/hour * 5,487

4. Trainer time (Counted as working

hours)

1-2 experienced

nurses

0

Total cost 8,155

* Nursing salary (per hour) = 31,200 / (44x4) = HKD 177.

Estimated savings from prone positioning

Items Item description Estimated price

(HKD)

Estimated

benefit

Total price saved

(HKD)

Oxygen

consumption

(per case)

-- 2,713/day * 10%

reduction **

271.3/day

Prevalence of

pneumonia

(per case)

It further saves the

cost of advanced

antibiotics used and

shortens length of

ICU stay.

Antibiotics: 500/day

ICU bed: 13,900/day

27%

reduction ***

Antibiotics: 135/day

ICU bed: 3,753/day

Mortality -- 17%

reduction

****

Not estimated

Total cost 4,159.3/day

1,518,144/year

* 1L O2 cost HKD 26/hour, the price used 100% O2 in calculation.

(26/23%) x 100% x 24= 2,713

** Estimated based on Guerin et al. (2013) and Mancebo et al. (2006) studies.

*** Estimated based on Voggenreiter et al. (2005) study.

**** Estimated based on Guerin et al. (2013) study.

79

Appendix 7 Recommendations of the Innovation


Patients who have severe hypoxemia with PaO2/FiO2 ratio < 150mmHg, FiO2 ≥ 0.6 and

PEEP ≥ 5cm of water and require MV are benefit from prone positioning.

Evidence:

- Patients recruited in the studies met the American-European Consensus Conference

criteria for ARDS that PaO2/FiO2 ratio was equal to or less than 200mmHg. The mean of

PaO2/FiO2 ratio among the patients was below 150mmHg showed a significantly increase in

oxygenation (Fernandez et al., 2008 (1+); Gattinoni et al., 2001 (1+); Mancebo et al., 2006

(1+); Taccone et al., 2009 (1+); Robak et al., 2011 (1-)) and decrease in mortality after prone

positioning (Guerin et al., 2013 (1++)).


Patients are contraindicated for prone positioning if they have cerebral edema with

elevated intracranial pressure >30mmHg and cerebral perfusion pressure <60mmHg, unstable

fractures of pelvic, femur or spine, severe hemodynamic instability, pregnancy and elevated

intra-abdominal pressure.

Evidence:

- Patients were excluded in the studies if their clinical condition were contraindicated for

prone positioning. (Fernandez et al., 2008 (1+); Gattinoni et al., 2001 (1+); Guerin et al.,

2004 (1+); Guerin et al., 2013 (1++); Mancebo et al., 2006 (1+); Papazian et al., 2005 (1-);

Robak et al., 2011 (1-); Taccone et al., 2009 (1+); Voggenreiter et al., 2005 (1+)).


Prone positioning should be initiated within 36 hours upon ARDS diagnosis.

Evidence:

- Earlier prone positioning could be more effective in reducing incidence of VAP (Guerin

et al., 2004 (1+)), decreasing mortality (Guerin et al., 2013 (1++)), decreasing FiO2

consumption (Mancebo et al., 2006 (1+)) and increasing PaO2/FiO2 ratio (Fernandez et al.,

2008 (1+); Guerin et al., 2004 (1+); Guerin et al., 2013 (1++); Mancebo et al., 2006 (1+);

Papazian et al., 2005 (1-)).

80


The duration of prone positioning should be at least 17hours/day.

Evidence:

- Patients experienced a mean prone positioning time was 17 hours/day (Guerin et al., 2013

(1++); Mancebo et al., 2006 (1+)), 18 hours/day (Taccone et al., 2009 (1+)) and 20 hours/day

(Fernandez et al., 2008 (1+)).

- Guerin et al. (2013, 1++) showed 17 hours/day for prone positioning significantly

decreased the mortality rate, increased PaO2/ FiO2 ratio without significant complications.


Prone positioning should be continued at least 4 days.

Evidence:

- Prone positioning significantly increased more in PaO2/FiO2 ratio in the first 4 days

(Voggenreiter et al., 2005 (1+)).

- Studies performed prone positioning continuously until oxygenation improvement

(Fernandez et al., 2008 (1+); Gattinoni et al., 2001 (1+); Guerin et al., 2013 (1++); Papazian

et al., 2005 (1-)).

- Guerin et al. (2013, 1++) study continued prone positioning for average 4 ± 4 days per

patient. It improved patients’ oxygenation with PaO2/FiO2 ratio ≥ 150mmHg, PEEP ≤ 10cm

of water and FiO2 ≤ 0.6.


Protective lung ventilation should be applied during prone positioning.

Evidence:

- Protective lung ventilation avoided alveolar overdistention and further reduced lung

injury. It also prevented alveolar collapse by maintaining open recruited alveoli (Papazian et

al., 2005 (1-)).

- Tidal volume was kept 6ml/kg of patients’ body weight, the end-inspiratory plateau

pressure ≤ 30cm of water and the respiratory rate of patient should not exceed 35breath/min.

PEEP setting was based on FiO2 requirements (Fernandez et al., 2008 (1+); Guerin et al.,

2013 (1++); Taccone et al., 2009 (1+); Voggenreiter et al., 2005 (1+)).

81


Protective pads should support patients’ forehead, chest, knees and iliac crests during prone

positioning.

Evidence:

- With the use of protective pads, the abdominal movement was free and the presence of

pressure sore in prone positioning was statistically insignificant comparing with supine

position. (Guerin et al., 2013 (1++); Mancebo et al., 2006 (1+)).


Patients’ heads and necks should be turned laterally every two hours during prone

positioning.

Evidence:

- Guerin et al. (2013, 1++) and Mancebo et al. (2006, 1+) turned patients’ heads and necks

alternatively to right or left in order to minimize the localized pressure successfully.


Physiological variables of patients should be continuously monitored and documented just

before prone positioning, 1 hour after prone positioning, just before turning back to supine

position and 4 hours later.

Evidence:

- Blood gas analysis, pulse oximetry and ventilator variables were recorded to measure

oxygenation improvement (Fernandez et al., 2008 (1+); Gattinoni et al., 2001 (1+); Guerin et

al., 2004 (1+); Guerin et al., 2013 (1++); Mancebo et al., 2006 (1+); Papazian et al., 2005 (1-);

Robak et al., 2011 (1-); Taccone et al., 2009 (1+); Voggenreiter et al., 2005 (1+)).

- Continuous monitoring was preferred (Robak et al., 2011 (1-)).

- Biomedical variables used to monitor patients for non-pulmonary system failure such as

hepatic, renal, circulatory and coagulation failure (Gattinoni et al., 2001 (1+); Voggenreiter et

al., 2005 (1+)).


Nurse should monitor and record the presence of VAP.

Evidence:

- VAP was detected by the presence of a new radiographic infiltrate, body temperature

greater than 38℃or lower than 36℃, purulent tracheal aspirates and total white cell count

lower than 4,000 × 10³µL or greater than 12,000 × 10³µL (Guerin et al., 2004 (1+);

Voggenreiter et al., 2005 (1+)).

82


Patients’ skin integrity should be observed every shift.

Evidence:

- The presence, site and severity of pressure sores were recorded at baseline and daily

during morning assessment (Gattinoni et al., 2001 (1+); Guerin et al., 2004 (1+); Guerin et al.,

2013 (1++); Mancebo et al., 2006 (1+); Voggenreiter et al., 2005 (1+)).

- Pressure sores were classified according to the four stage system of the National Pressure

Ulcers Advisory Panel (Gattinoni et al., 2001 (1+)).


Prone positioning should be terminated if patients’ oxygenation improves or deteriorates

and major complication occurs.

Evidence:

- Oxygenation improvement defined as PaO2/FiO2 ratio ≥ 150mmHg with PEEP ≤ 10cm

of water and FiO2 ≤ 0.6. It should be achieved at least 4 hours after turning back to supine

position (Fernandez et al., 2008 (1+); Guerin et al., 2004 (1+); Guerin et al., 2013 (1++);

Mancebo et al., 2006 (1+)).

- PaO2/FiO2 ratio deterioration noted when more than 20% reduction compared with

supine before two consecutive prone days (Guerin et al., 2013 (1++)).

- Major complications included non-scheduled extubation, endotracheal tube obstruction,

major desaturation with SpO2 <85% or PaO2 < 55mmHg for 5 minutes under FiO2=1.0,

hemodynamic instability with heart rate < 30 beats/min for 1 minute, systolic blood pressure

<60 mmHg for more than 5 minutes, cardiac arrest or any other life-threatening reason for

termination (Guerin et al., 2004 (1+); Guerin et al., 2013 (1++); Taccone et al., 2009 (1+)

Voggenreiter et al., 2005 (1+)). This complications directly affected the mortality rate of

patients (Mancebo et al., 2006 (1+)).

83

Appendix 8 Flow of Communication

2 weeks for forming group

1 month for approval

1.5 months for promotion

Journal Club

MO conference Training workshop Internal emails Posters

Internal e-mails Nursing grand round

Ward meeting

Follow nurses’ instructions

Proposer

Core Group Members

(1 AC, 1 APN, 2 nurses and proposer)

Administrators

(COS, DOM, WM and NC)

ICU

ACs and

MOs

ICU

APNs

ICU

nurses

Supporting groups

(X-ray department,

Laboratory)

ICU PCAs

Patients with

ARDS and their

relatives

84

Appendix 9 Evaluation Questionnaire of Journal Club

Evaluation questionnaire for healthcare providers (Self-developed)

Name: __________________

Date: ___________________

Please circle an appropriate number in the following questions.

9. Strengths of the presentation:

10. Weakness of the presentation:

11. Suggestions for improvement:

Strongly

Disagree

Disagree Neutral Agree Strongly

Agree

1. The objectives of presentation are clear. 1 2 3 4 5

2. The content of presentation is understandable. 1 2 3 4 5

3. I understand the benefit of prone positioning for

patients with ARDS.

1 2 3 4 5

4. I am clear about the selection criteria for target

patients.

1 2 3 4 5

5. Information of assessment and evaluation skills

for prone positioning is useful.

1 2 3 4 5

6. The highlights of new prone positioning

guideline are relevant.

1 2 3 4 5

7. The time schedule for training is clear. 1 2 3 4 5

8. Overall, I am satisfied with the presentation. 1 2 3 4 5

85

Appendix 10 Evaluation Questionnaire of Training Workshop


Name: __________________

Date: ___________________


9. Strengths of the workshop:

10. Weakness of the workshop:


Strongly

Disagree


Agree

1. The objectives of workshop are clear. 1 2 3 4 5

2. The content of workshop is relevant. 1 2 3 4 5

3. Instructions are clear during practice. 1 2 3 4 5

4. Instructors are expertise in the related field. 1 2 3 4 5

5. I understand the technique of prone positioning

after this workshop.

1 2 3 4 5

6. I have acquired adequate skills in carrying out

prone positioning.

1 2 3 4 5

7. The duration of the workshop is adequate. 1 2 3 4 5

8. Overall, I am satisfied with the workshop. 1 2 3 4 5

86

Appendix 11 Evaluation Questionnaire of Pilot Study


Name: __________________

Date: ___________________


10. Strengths of the pilot study:

11. Difficulties encountered during the pilot study:


Strongly

Disagree


Agree

1. The guideline is easy to carry out. 1 2 3 4 5

2. Time to carry out prone positioning is adequate. 1 2 3 4 5

3. Resources are adequate to implement the

guideline.

1 2 3 4 5

4. Supports are adequate to implement the

guideline.

1 2 3 4 5

5. Patients benefit from prone positioning. 1 2 3 4 5

6. The guideline is feasible to implement for long

term.

1 2 3 4 5

7. I am competent in conducting the guideline. 1 2 3 4 5

8. I am stressful in conducting the guideline. 1 2 3 4 5

9. My job satisfaction is increased by taking part

in the guideline.

1 2 3 4 5

10. I recommend the guideline to other staff. 1 2 3 4 5

11. Overall, the guideline is worth conducting. 1 2 3 4 5

Documents

“Evidence B uideline of Prone Positioning for Adult ...nursing.hku.hk/dissert/uploads/Wong Sze Lok Rebecca.pdf · cute Respiratory Distress Syndrome in Intensive Care Unit ... to