CLINICAL EVIDENCE GUIDE

AN EARLY INDICATOR OF DECLINE IN PATIENTS ON THE GENERAL CARE FLOOR (GCF)

This guide will help you review the clinical evidence that supports the utility of capnographic monitoring in optimizing the care of GCF patients.

Microstream™ etCO2 monitoring technology provides accurate respiratory rate derived from CO2 waveforms, CO2 values, and breath-by-breath CO2 waveforms in intubated and nonintubated patients. Microstream™ capnography may help you recognize respiratory compromise earlier — so you can intervene more quickly.

OVERVIEW

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TABLE OF CONTENTSTABLE OF CONTENTS

3 OVERVIEWOverview of the utilization of capnographic monitoring in optimizing the care of GCF patients

8 LEE 2015Summary of: Lee LA, Caplan RA, Stephens LS, et al. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015;122(3):659-665.

10 OVERDYK 2007Summary of: Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007;105(2):412-418.

12 HUTCHINSON 2008Summary of: Hutchinson R, Rodriguez L. Capnography and respiratory depression. Am J Nurs. 2008;108(2):35-39.

13 McCARTER 2008Summary of: McCarter T, Shaik Z, Scarfo K, Thompson LJ. Capnography monitoring enhances safety of postoperative patient-controlled analgesia. Am Health Drug Benefits. 2008;1(5):28-35.

15 REFERENCES List of works cited

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Respiratory compromise consists of respiratory failure, arrest, and insufficiency or depression.Respiratory compromise is common on the GCF.

∙ More than one-quarter of acute respiratory events occur on the GCF.1

∙ In postoperative patients, respiratory compromise requiring reintubation occurs in 2.2% of patients2 and is the primary cause of ICU recidivism.3

∙ Continuous monitoring with etCO2 reveals that up to 41% of patients receiving opioids on the GCF suffer respiratory compromise as defined as respiratory rate < 10 breaths per minute (BPM).4

Respiratory compromise on the GCF is associated with adverse events, poor outcomes, and excess charges.

∙ Inpatients with respiratory compromise originating on the GCF have higher mortality rates (34.6%) than nonrespiratory compromise cases (1.2%) and longer lengths of hospital stays (11.5 days) than nonrespiratory compromise cases (4.1 days).5

∙ The average cost per postoperative respiratory failure event is $53,500, which totaled $1.9 billion in excess charges in 40 million Medicare hospitalizations from 2007 to 2009.6

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OVERVIEW (cont’d.)The etiology of respiratory compromise leading to adverse events on the GCF is influenced by several patient-specific comorbidities and iatrogenic factors that place patients at additional risk for respiratory compromise.Iatrogenic factors include:

∙ Postoperative respiratory muscle dysfunction, in which patients are predisposed for airway obstruction and respiratory pump muscle fatigue7 due to the negative influence on the upper airway muscles and respiratory pump muscles by:

– Multiple medications (opioids, neuromuscular blocking agents, and sedatives)

– Perioperative interventions (mechanical ventilation)

– Patient comorbidities (OSA, obesity, chronic pulmonary disease)

∙ Opioid administration, which:

– Is associated with risk for respiratory depression, which can lead to respiratory failure or death8

– Has become ubiquitous in both surgical (98%)9 and nonsurgical (51%)10 patients, in the wake of Joint Commission Pain Management Standard (PC.01.02.07)

– May be a factor in respiratory opioid-related adverse drug events, which occur in 4% of postoperative patients receiving opioids9

∙ Other medications, with:

– Residual neuromuscular blockade demonstrated to be associated with postoperative respiratory complications11

– Coadministration of nonopioid sedatives implicated in 34% of postoperative opioid-related respiratory depression closed claims12

OVERVIEW

Iatrogenic risk factors for respiratory compromise

Iatrogenic Factors Odds Ratio Iatrogenic Factors Odds Ratio

Higher dose opioids13 1.3 Nonelective surgery14 1.82

High-risk surgery15 2.6 Open vs. laparascopic16 3.09

Intra-abdominal procedures17 1.6 Operative time > 240 min17 3

Medium-risk surgery15 2.2 Very high-risk surgery15 5.3

Neuromuscular blockade administration11 1.4

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OVERVIEW (cont’d.)

OVERVIEW

Patient-specific factors

Multiple patient-specific factors negatively influence respiratory function — placing patients at increased risk for respiratory compromise

Patient-specific risk factors for respiratory compromise

Risk Factor Odds Ratio Risk Factor Odds Ratio

Age 50–64 vs. <35 years16 3.95 Current smoker15 1.5

Age 65–79 vs. <35 years16 7.06 Diabetes, insulin treated15 1.3

Age 80+ vs. <35 years16 9.76 Dyspnea15 1.6

Alcohol use15 1.4 Hypertension15 1.4

ASA score > 317 2.68 Hypoalbuminemia17 2.75

BMI < 18.5 kg/m215 1.5 Male16 1.24

BMI > 40.0 kg/m215 1.3 Obesity14 1.18

Cancer15 1.5 Sleep apnea14 1.17

CHF15 1.6 Weight loss15 1.5

COPD15 1.6

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OVERVIEW (cont’d.)Additional monitoring of ventilatory status with capnography may provide an early indicator of decline in patients on the GCF.Because hypoventilation and apnea precede hypoxia, end-tidal carbon dioxide should be affected before oxygen saturation.18

∙ Continuous monitoring of respiratory rate via etCO2 provides greater fidelity to incidents of respiratory compromise than SpO2.24

∙ Studies investigating the incidence of bradypnea with continuous etCO2 monitoring reveal a significantly greater rate of bradypnea than those using retrospective chart reviews.4,19

As patients on the GCF are assessed only periodically, they’re at an increased risk for unrecognized events.20,21

∙ Delayed interventions occurs in 50% of patients with respiratory distress on the GCF, with a median duration of delay of 12 hours.22

∙ Delayed interventions are associated with an increase in mortality in patients with respiratory distress on the GCF.22

In-hospital adverse events are frequently preceded by deterioration of respiratory function.

∙ Thirty-eight percent of cardiopulmonary arrests are proceeded by acute respiratory compromise.23

∙ Unsurprisingly, continuously monitoring patients for extremes of etCO2 and respiratory rate may provide clinicians with an early indicator of patient decline, facilitating early intervention and enhancing patient safety.24,25

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Several societies have published guidelines promoting the utility of capnography for the detection or prevention of respiratory compromise in patients receiving opioids.

Society Guideline

Anesthesia Patient Safety Foundation (ASPF)26

Essential Monitoring Strategies to Detect Clinically Significant Drug Induced Respiratory Depression

American Society of Anesthesiologists (ASA)27

Practice Guidelines for the Prevention, Detection, and Management of Respiratory Depression Associated with Neuraxial Opioid Administration

Institute for Safe Medication Practices28 Reducing Patient Harm from Opiates

Institute for Healthcare Improvement (IHI)29 How-to Guide: Prevent Harm from High-Alert Medications

Joint Commission30 Safe Use of Opioids in Hospitals

OVERVIEW (cont’d.)

OVERVIEW

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LEE 2015

Lee LA, et al. Postoperative opioid-induced respiratory depression: a closed claims analysis.Anesthesiology. 2015;122(3):659-665.

LEE 2015

STUDY INFORMATION

PURPOSE Analyze postoperative opioid-induced respiratory depression closed claims in order to determine patterns in etiology and injury

STUDY DESIGN Investigators retrospectively examined the Anesthesia Closed Claim Project database (9,799 claims) for postoperative respiratory depression-related claims. Ninety-two definitive, probable, or possible respiratory depression claims were identified from 357 acute pain closed claims.

PARTICIPANTS 92 claims identified as possible, probable, or definite respiratory depression from the Anesthesia Closed Claims database of 9,799 claims

RESULTS Patient Characteristics Opioid Therapy Characteristics Severity of Injury

Obese 66% Continuous infusion 46% Death (%) 55%

ASA status 1–2 63% Interaction of opioid and nonopioid sedative medications

34% Permanent brain damage (%)

22%

OSA diagnosis 16% More than one physician prescribing

33% Temporary/minor 23%

High OSA risk 9% Excessive opioid dose 16%

≥50 years of age 44% PCA only (%) 18%

History of chronic opioid use

8% Neuraxial only (%) 17%

Lower extremity surgery 41% Non-PCA intravenous, oral only, or transdermal (%)

17%

Female 57% Multimodal (%) 47%

Experienced heavy snoring 15%

Experienced somnolence 62%

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LEE 2015 (cont’d.)RESULTS (cont’d.)

Patient Care Characteristics Timing of Event Influence of Monitoring

Monitoring: Pulse oximetry

33% Day of surgery 88 Would better monitoring have prevented the complication? Probably (%)

47%

Monitoring: No respiratory monitoring

58% 2 hours of arrival on floor

13 Would better monitoring have prevented the complication? Possibly (%)

50%

Inadequate nursing checks

31% Would better monitoring have prevented the complication? No (%)

3%

Supplemental oxygen 15%

CONCLUSION Many opioid-induced adverse events related to respiratory depression are potentially preventable with improved monitoring of oxygenation and ventilation.

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OVERDYK 2007

OVERDYK 2007Overdyk FJ, et al. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007;105(2):412-418.

STUDY INFORMATION

PURPOSE Determine the incidence of respiratory depression in postsurgical patients undergoing patient-controlled analgesia on the hospital ward as indicated by continuous monitoring of oximetry and capnography

METHODS Postoperative patients (n=178) receiving patient-controlled analgesia on the ward were assigned to receive morphine or meperdine by their surgeons. PCA settings were determined according to patients’ needs and physicians’ orders. Continuous monitoring data were analyzed for the following outcomes:

∙ Incidence of patients with bradypnea (RR <10 for ≥3 minutes)

∙ Incidence of patients with desaturation (SpO2 <90% for ≥3 minutes)

∙ Number of desaturation events preceded by bradypnea

PARTICIPANTS 178 postsurgical patients undergoing patient-controlled analgesia on the hospital ward

RESULTS Incidence of patients with bradypnea (RR <10 for ≥3 minutes) 41%

Incidence of patients with desaturation (SpO2 <90% for ≥3 minutes) 12%

Incidence of patients with bradypnea (RR <10 for ≥2 minutes) 58%

Incidence of patients with desaturation (SpO2 <90% for ≥2 minutes) 21%

Percentage of desaturation events preceded by bradypnea 28%

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RESULTS (cont’d.)

Risk Factors for Bradypnea*

Continuous Background Infusion

No Continuous Background Infusion

P Value

Percentage of patients with bradypnea (RR <10 for ≥3 minutes)

32% 53% <0.01

Aged 65 Years or Older Less Than 65 Years P Value

Percentage of patients with bradypnea (RR <10 for ≥3 minutes)

66.7 36.4 <0.01

Supplemental Oxygen No Supplemental Oxygen P Value

Percentage of patients with bradypnea (RR <10 for ≥3 minutes)

73 38 0.01

CONCLUSION Continuous monitoring of ventilation and oxygenation reveals a significantly higher incidence of respiratory depression than previous studies relying on retrospective chart reviews. Patients receiving supplemental oxygen were more likely to have prolonged episodes of bradypnea without desaturation, which may be indicative of pulse oximetry being a late indicator of hypoventilation. Desaturation and bradypnea tended to be more common in patients age 65 years or older and less common in patients receiving continuous background infusions.

*Nonsignificant outcomes included sleep apnea and obesity.

OVERDYK 2007 (cont’d.)

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HUTCHINSON 2008

Hutchinson R, et al. Capnography and respiratory depression. Am J Nurs. 2008;108(2):35-39.

HUTCHINSON 2008

STUDY INFORMATION

PURPOSE Assess the efficacy of continuous monitoring of ventilation via capnography to identify respiratory depression in high risk opioid-naive postoperative orthopedic patients on the GCF compared with spot check care monitoring

STUDY DESIGN

Patients were included if they met at least one of the following criteria for high risk for respiratory depression: BMI ≥30, history of snoring, PACU episode of RR <10 BPM, or continuous infusion of IV opioid or continuous release opioid. Participants were randomized to receive intermittent monitoring with pulse oximetry and respiration rate by observation or auscultation, or continuous monitoring of ventilation via capnography. The primary outcome was the detection of episodes of respiratory depression. Respiratory depression was defined as RR <6 BPM, apnea >20 seconds, etCO2 <60 mmHg, or SpO2 <88%.

PARTICIPANTS 54 postoperative orthopedic patients receiving analgesia (hydromorphone, fentanyl, hydrocodone, oxycodone, or meperidine) on the GCF

RESULTS Capnography Group Control Group P Value

Detected episodes of respiratory depression

140 6 0.03

Percentage of patients with detected pauses in breathing while sleeping

48 24 N/A

Enrollment criteria predictive of subsequent respiratory depression

Respiratory rate < 10 BPM in the PACU

CONCLUSION In postoperative patients receiving opioids on the GCF, continuous monitoring with capnography captures a significantly greater number of episodes of respiratory depression than spot check assessment of SpO2 and respiratory rate.

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McCARTER 2008

McCarter T, et al. Capnography monitoring enhances safety of postoperative patient-controlled analgesia. Am Health Drug Benefits. 2008;1(5):28-35.

McCARTER 2008

STUDY INFORMATION

PURPOSE Assess the utility of capnography monitoring, in addition to pulse oximetry, for early detection of respiratory abnormalities in postoperative patients undergoing patient controlled analgesia

METHODS Postoperative patients undergoing patient-controlled analgesia with hydromorphone, morphine, or fentanyl were continuously monitored for respiratory events with capnography in addition to standard monitoring (vital signs, nausea, sedation level, pain scale, and SpO2). Respiratory events were indicated by capnography values (RR, etCO2) crossing standard alarms thresholds (etCO <20 mmHg or >50 mmHg, respiratory rate <6 BPM or >38 BPM, apnea >20 seconds). Pulse oximetry did not alarm in any patients (SpO2 >92%).

The study outcomes included the number and characteristics of patients with respiratory events requiring an intervention to prevent further complications. All PCA pumps were equipped with an automatic feature that paused drug administration if specific capnographic thresholds were crossed.

PARTICIPANTS 634 postoperative patients undergoing patient-controlled analgesia with hydromorphone, morphine, or fentanyl

RESULTS Number of patients suffering PCA-related respiratory events 9 (1.4%)

Number of respiratory events alerted by capnography 9

Number of respiratory events alerted by pulse oximetry (SpO2 >92%) 0

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McCARTER 2008 (cont’d.)RESULTS (cont’d.)

Characteristics of Patients Suffering Respiratory Depression (N=9)

Mean age (years) 67.5

Receiving supplemental oxygen 9

Rapid response team called 4

Nurse successfully stimulated patient to breath 2

Naloxone administered 4

PCA basal rate administered 2

Received hydromorphone 6

Received morphine 3

CONCLUSION Capnography, but not pulse oximetry, alerted physicians to all cases of respiratory events requiring an intervention to prevent further complications. Pulse oximetry may be a late indicator of respiratory compromise in postoperative patients receiving patient-controlled analgesia with supplemental oxygen. PCA pumps equipped with an automatic feature that pauses drug administration if specific capnographic thresholds are crossed may improve patient safety.

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REFERENCES

1. Wang HE, Abella BS, Callaway CW. Risk of cardiopulmonary arrest after acute respiratory compromise in hospitalized patients. Resuscitation. 2008;79(2):234-240.

2. Hua M, Brady JE, Li G. A scoring system to predict unplanned intubation in patients having undergone major surgical procedures. Anesth Analg. 2012;115(1):88-94.

3. Vohra HA, Goldsmith IR, Rosin MD, Briffa NP, Patel RL. The predictors and outcome of recidivism in cardiac ICUs. Eur J Cardiothorac Surg. 2005;27(3):508-511.

4. Overdyk FJ, Carter R, Maddox RR, Callura J, Herrin AE, Henriquez C. Continuous oximetry/capnometry monitoring reveals frequent desaturation and bradypnea during patient-controlled analgesia. Anesth Analg. 2007;105(2):412-418.

5. Kelley S, Agarwal S, Parikh N, Erslon M, Morris P. Respiratory insufficiency, arrest and failure among medical patients on the general care floor. Crit Care Med. 2012;40(12 (Suppl)):764.

6. Reed K, May R. HealthGrades Patient Safety in American Hospitals Study. Healthgrades. https://www.hospitals.healthgrades.com/CPM/assets/File/HealthGradesPatientSafetyInAmericanHospitalsStudy2011.pdf. Published March 2011.

7. Sasaki N, Meyer MJ, Eikermann M. Postoperative respiratory muscle dysfunction: pathophysiology and preventive strategies. Anesthesiology. 2013;118(4):961-978.

8. Overdyk F, Dahan A, Roozekrans M, van der Schrier R, Aarts L, Niesters M. Opioid-induced respiratory depression in the acute care setting: a compendium of case reports. Pain Manag. 2014;4(4):317-325.

9. Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4):383-391.

10. Herzig SJ, Rothberg MB, Cheung M, Ngo LH, Marcantonio ER. Opioid utilization and opioid-related adverse events in nonsurgical patients in US hospitals. J Hosp Med. 2014;9(2):73-81.

11. Grosse-Sundrup M, Henneman JP, Sandberg WS, et al. Intermediate acting non-depolarizing neuromuscular blocking agents and risk of postoperative respiratory complications: prospective propensity score matched cohort study. BMJ. 2012;345:e6329.

12. Lee LA, Caplan RA, Stephens LS, et al. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015;122(3):659-665.

13. Oderda GM, Said Q, Evans RS, et al. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007;41(3):400-406.

14. Agarwal S, Erslon M, Seda J, Kelley S. Large national database highlights significant risk factors for respiratory complications and mortality after abdominal surgery. Crit Care Med. 2011;39(Suppl 12):588.

15. Ramachandran SK, Nafiu OO, Ghaferi A, Tremper KK, Shanks A, Kheterpal S. Independent predictors and outcomes of unanticipated early postoperative tracheal intubation after nonemergent, noncardiac surgery. Anesthesiology. 2011;115(1):44-53.

16. Kelley SD, Agarwal SJ, Erslon MG, Seda J, Lautz DB. Risk factors for respiratory insufficiency, arrest and failure among selected open and laparoscopic procedures - Analysis of 90,000+ procedures. Surg Endosc. 2012;26(Suppl 1):P565.

17. Fischer JP, Shang EK, Butler CE, et al. Validated model for predicting postoperative respiratory failure: analysis of 1706 abdominal wall reconstructions. Plast Reconstr Surg. 2013;132(5):826e-835e.

18. Langhan ML, Chen L, Marshall C, Santucci KA. Detection of hypoventilation by capnography and its association with hypoxia in children undergoing sedation with ketamine. Pediatr Emerg Care. 2011;27(5):394-397.

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OVERVIEW

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19. Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004;93(2):212-223.

20. Galhotra S, DeVita MA, Simmons RL, Schmid A. Impact of patient monitoring on the diurnal pattern of medical emergency team activation. Crit Care Med. 2006;34(6):1700-1706.

21. Hodgetts TJ, Kenward G, Vlackonikolis I, et al. Incidence, location and reasons for avoidable in-hospital cardiac arrest in a district general hospital. Resuscitation. 2002;54(2):115-123.

22. Quach JL, Downey AW, Haase M, Haase-Fielitz A, Jones D, Bellomo R. Characteristics and outcomes of patients receiving a medical emergency team review for respiratory distress or hypotension. J Crit Care. 2008;23(3):325-331.

23. Peberdy MA, Ornato JP, Larkin GL, et al. Survival from in-hospital cardiac arrest during nights and weekends. JAMA. 2008;299(7):785-792.

24. Cretikos M, Chen J, Hillman K, Bellomo R, Finfer S, Flabouris A. The objective medical emergency team activation criteria: a case-control study. Resuscitation. 2007;73(1):62-72.

25. Maddox R, Oglesby H, Williams CK, Fields M, Danello S. Continuous Respiratory Monitoring and a “Smart” Infusion System Improve Safety of Patient-Controlled Analgesia in the Postoperative Period. AHRQ. http://www.ahrq.gov/downloads/pub/advances2/vol4/Advances-Maddox_111.pdf. Published 2005.

26. Essential Monitoring Strategies to Detect Clinically Significant Drug-Induced Respiratory Depression in the Postoperative Period. Conclusions and Recommendations. APSF. http://www.apsf.org/announcements.php?id=7. Accessed September 28, 2011.

27. Horlocker TT, Burton AW, Connis RT, et al. Practice guidelines for the prevention, detection, and management of respiratory depression associated with neuraxial opioid administration. Anesthesiology. 2009;110(2):218-230.

28. HIGH ALERT Medication Feature: Reducing patient harm from opiates. https://www.ismp.org/newsletters/acutecare/articles/20070222.asp. Published February 22, 2007.

29. How-to Guide: Prevent Harm from High-Alert Medications. Institute for Healthcare Improvement. http://www.ihi.org/resources/Pages/Tools/HowtoGuidePreventHarmfromHighAlertMedications.aspx. Published 2012.

30. Safe use of opioids in hospitals. The Joint Commission. https://www.jointcommission.org/assets/1/18/SEA_49_opioids_8_2_12_final.pdf. Published August 8, 2012.

REFERENCES (cont’d.)

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REFERENCES

McCARTER 2008