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October 2013 RESPIRATORY CARE Journal Webcast

Moderator

Shawna Strickland, PhD, RRT-NPS, AE-C, FAARC AARC Associate Executive Director-Education

Program Objectives

Identify the research question of the study.

Identify the study design.

Discuss the main results of the study.

Discuss the implication of the study on patient care.

The Impact of Hospital-Wide Use of a Tapered Cuff Endotracheal Tube on the Incidence of Ventilator Associated Pneumonia

RESPIRATORY CARE • OCTOBER 2013 VOL 58 NO 10

Steven Holets BS RRTAssistant Professor of Anesthesiology

Mayo Clinic College of Medicine

• Researchers: – David L. Bowton, MD, FCCP, R. Duncan Hite, MD, R.

Shayn Martin, MD, Robert Sherertz, MD

• Facility:– Wake Forest Baptist Hospital, Winston Salem NC

• Nationally ranked academic medical center• 1000+ beds• >100 ICU beds

Conflict of Interest

• Investigator initiated study.– Drs Bowton and Hite partly supported by NIH grants– Drs. Martin and Sherertz reported no COI

• Industry support (Covidien):– Provided discounted study device (tapered ETT) – Money for personnel costs (data collection).– No involvement in:

• Study design• Data collection or analysis• Study conclusions

– Reviewed manuscript prior to submission.

What is the research question?• Hypothesis:

– Hospital use of a tapered cuff endotracheal tube would result in a significant reduction in the rate of Ventilator Acquired Pneumonia (VAP).

• “A research question is essentially a hypothesis asked in the form of a question.”

• Research question:– Does the use of a tapered cuff endotracheal tube

reduce the incidence of VAP compared to a standard cuffed endotracheal tube?

Is the question relevant?

Ventilator Associated Pneumonia VAP Background

• VAP rate is defined as the number of ventilator-associated pneumonias per 1,000 ventilator days.

• VAP Incidence 0.0 – 8.5/1000 vent days.• Attributed mortality 10- 30%• VAP adds up to $40,000 additional cost to admission.

– Longer ventilator days– Longer ICU stay– More antibiotic usage

• Institute for Healthcare Improvement 100,000 lives campaign– VAP Bundle: HOB elevation, peptic ulcer and deep vein thrombosis prophylaxis, oral care

with chlorhexadine, sedation vacation for weaning readiness.

• Consideration for non-reimbursement by the Centers for Medicare and Medicaid.

National Hospital Safety NetworkVentilator Associated Event (VAE)

Surveillance Algorithm 2013

Ventilator Associated Events

• Tier 1– VAC

• Tier 2– IVAC

• Tier 3– VAP

Respir Care 2013;58(6):990 –1003

What is known about this subject?

• Increased VAP risk factors associated with ETT – Impairment of the mucocilliary transport system– Pooling of secretions above cuff– Biofilm formation on ETT surface

• Bacterial reservoir

– Tracheal contamination due to microaspiration• Folds in cuff along trachea wall• Low cuff pressure• Zero PEEP• Patient movement

ETT innovations for the prevention of VAP

• Biofilm prevention– Silver coated

• Reduction in VAP incidence 4.8% vs. 7.5%, (P .03)• Delayed VAP occurrence (P 0.05)• No significance in Mortality, ICU, or hospital stay

JAMA 2008 Aug 20;300(7):805-13

– Biofilm removal• Mucus Shaver®• Rescue Cath ®

• Secretion pooling– Subglottic secretion drainage (SSD)

• Suction port above cuff• Level I evidence

ETT innovations for the prevention of VAP

• Cuff development– Material

• Polyvinyl chloride (PVC)• Polyurethane (PU)

– Cuff Shape• Cylindrical/barrel• Tapered

Methods• Study design:

– Two period observational study

• Inclusion criteria:– All adult intubated patients in all ICUs– VAP bundle and data collection standardized– PNEU2 VAP definition

• Groups:– Control: Mallickrodt Hi-Lo ® (barrel cuff PVC)– Intervention: Mallickrodt TaperGuard ® (tapered cuff PVC)

• Power analysis:– Estimated 6 month trial period to attain adequate number of patients– Pre study VAP rate 5.8 + 1.47/ 1000 vent days

• Statistical analysis:– Chi-square tests for proportions, unpaired Students T tests for continuous variables, 2

tailed P value of <0.05 was considered significant

Audience question

1. Do you think the study design is appropriate?

What are the threats to validity of the design?

• Nonrandomized study– Quasi-experimental

• Internal validity– History

• Cannot guarantee that something won’t change between groups during the course of the study.

• External validity– Multiple treatment interference

• As multiple treatments are given to the same subjects, it is difficult to control for the effects of prior treatments.

Results

Results

Results

Results

Discussion

• What do the findings mean?– In this study, tapered cuff endotracheal tubes were not

significantly better than standard cuffed tubes in VAP prevention.

– Adherence to VAP bundle may have influenced results.• Hawthorne effect

– Did it cause an increase in VAP bundle compliance during the control period that wore off during the intervention period?

• Confounding variables– Was there some unknown change between groups?

Audience question

2. Do you think the lower VAP Bundle adherence influenced the study results?

What are the study limitations?

• Two period observational study.• Single centered.• Reduced compliance to VAP bundle between groups.• Decrease in baseline group VAP 3.29/1000 vent days vs.

5.8/1000 in historically group rendered the study under powered to answer question.

• Inclusion of transferred patients with standard ETT in intervention group.

How should these findings influence practice?

• Adherence to VAP prevention bundle clearly decreases VAP rate.

• Insufficient evidence to justify expenditure for special tubes?

How do these findings related to previous findings from other studies?

• Laboratory studies– Effect of tracheal tube cuff shape on fluid leakage across the

cuff: an in vitro study British Journal of Anaesthesia 105 (4): 538–43 (2010)

• Results: Greater leakage in conventional cuff PVC vs. conventional PU vs. tapered PU (P 0.01)

– Benchtop study comparing leakages across cuffs of three endotracheal tubes Critical Care 2013, 17(Suppl 2):P152 (abstract)

• Results:• Tapered PU cuff and micro PU cuff outperformed conventional PVC

cuff under all scenarios (P < 0.01)• Maintaining Pcuff > 20cmH20 decreases leakage• Loss of PEEP increases leakage in conventional cuff PVC regardless of

cuff pressure.

How do these findings relate to previous findings from other studies?

• Animal studies– Do tracheal tubes prevent microaspiration? Brit J Anaesthesia 2011;107(5):821-822

• 14 anesthetized pigs intubated with Hi Lo standard cuff or SG tapered cuff ETT

• Dyed saline instilled above cuff• Autopsy examination of airways for leakage• Results: Less dye leak with tapered cuff 1/6 vs. standard cuff 7/7 (P

0.005) (reduced micro-aspiration)

How do these findings related to previous findings from other studies?

• Human studies:– Effect of positive expiratory pressure and type of tracheal cuff on the

incidence of aspiration in mechanically ventilated patients in an intensive care unit Crit Care Med 2008; 36(2):409-413.

• 40 Intubated patients: 20 HiLo PVC tube, 20 Sealguard PU tube had dye instilled above cuff and bronchscopy to examine for leakage at different timepoints

• Results: All HL cuffs leaked sooner than SG, PEEP improves sealing – Endotracheal tube with tapered-type cuff for preventing VAP: a

randomized clinical trail Critical Care March 2013, 17(Suppl 2):P153 (abstract)

• 289 patients receiving mechanical ventilation > 48 hours• Compared conventional cuff PVC with SSD vs. Tapered cuff PVC with SSD• Results: No difference in VAP rate 21.7% (P 1.0)

What additional work is needed in this area?

• Large multi-center randomized controlled trial (RCT).– Prospective design– Sufficient power to answer the question– Allow subgroup analysis

• Challenges:• Change in practice over time• Strict adherence to study protocol

– VAP bundles, Ventilator management

• Cost– Equipment, personnel

Editorial

Too Passive to Prevent Ventilator-Associated PneumoniaJuan Felipe Fernandez MD Marcos I Restrepo MD MSc

• Preventing cuff leakage may not be enough to reduce VAP.• Newer model of tapered tube with subglottic suction may work

better.• Higher adherence to VAP bundle (96% control group) may have

decreased VAP rate influencing results. • Patients with contraindications to VAP bundle adherence may

have bias results.• Monitoring VAP rate and adherence to VAP bundles should be

priority before considering ETT technologies.

Audience question

• Do you use special ETTs in your VAP prevention strategy?

Conclusions

• What are the authors’ conclusions?– In the setting of high adherence to a VAP prevention bundle, the use

of a tapered cuff ETT was not associated with a significant reduction in VAP rate.

• How do you think this should affect practice?– Concentrate on proven interventions, VAP bundle.

• What is the take-home message?– Laboratory findings do not necessarily transfer to improved clinical

outcomes.– Negative studies provide important information.– Highlights some of the difficulties of conducting a clinical trial.– Further research is needed before the question can be answered.

Documents

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