Incidence OIRD Medical and Trauma Patients

Sedation Clinical Trial

Official title:

Incidence of OIRD in Medical and Trauma Patients on the General Care Floor Receiving PCA or Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03948880
• Other study ID #: FresnoCHMC
• Status: Enrolling by invitation
• Start date: July 29, 2019
• Est. completion date: November 29, 2019

Study information

• Verified date: July 2019
• Source: Fresno Community Hospital and Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 101
• Est. completion date: November 29, 2019
• Est. primary completion date: October 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

1. Spontaneously breathing adults 18 to 89 years of age

2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain

3. Admitted to the general care floor from the emergency department

4. Able to provide written informed consent

Exclusion Criteria:

1. Age is less than 18 years or greater than 89 years

2. Transfer to the general care floor from the ICU

3. Provider order for respiratory monitoring using continuous capnography

4. Receiving intrathecal or epidural opioids

5. Trauma patient with a nerve block

6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor

7. History or diagnosis of a sleep disordered breathing syndrome

8. Use of CPAP or BIPAP non-invasive ventilation as home regime

9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)

10. Receiving non-invasive ventilation

11. Unable or unwilling to participate

12. Member of a vulnerable population such as pregnant women or prisoners

Related Conditions & MeSH terms

• Respiratory Depression
• Respiratory Insufficiency
• Sedation

Locations

Country	Name	City	State
United States	Community Regional Medical Center	Fresno	California

Sponsors (3)

Lead Sponsor	Collaborator
Fresno Community Hospital and Medical Center	Medtronic, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (26)

Andersen LW, Berg KM, Chase M, Cocchi MN, Massaro J, Donnino MW; American Heart Association's Get With The Guidelines(®)-Resuscitation Investigators. Acute respiratory compromise on inpatient wards in the United States: Incidence, outcomes, and factors associated with in-hospital mortality. Resuscitation. 2016 Aug;105:123-9. doi: 10.1016/j.resuscitation.2016.05.014. Epub 2016 May 30. — View Citation

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Belcher AW, Khanna AK, Leung S, Naylor AJ, Hutcherson MT, Nguyen BM, Makarova N, Sessler DI, Devereaux PJ, Saager L. Long-Acting Patient-Controlled Opioids Are Not Associated With More Postoperative Hypoxemia Than Short-Acting Patient-Controlled Opioids After Noncardiac Surgery: A Cohort Analysis. Anesth Analg. 2016 Dec;123(6):1471-1479. — View Citation

Canet J, Gallart L, Gomar C, Paluzie G, Vallès J, Castillo J, Sabaté S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a. — View Citation

Canet J, Sabaté S, Mazo V, Gallart L, de Abreu MG, Belda J, Langeron O, Hoeft A, Pelosi P; PERISCOPE group. Development and validation of a score to predict postoperative respiratory failure in a multicentre European cohort: A prospective, observational study. Eur J Anaesthesiol. 2015 Jul;32(7):458-70. doi: 10.1097/EJA.0000000000000223. — View Citation

Cashman JN, Dolin SJ. Respiratory and haemodynamic effects of acute postoperative pain management: evidence from published data. Br J Anaesth. 2004 Aug;93(2):212-23. Epub 2004 May 28. Review. — View Citation

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. — View Citation

Dahan A, Aarts L, Smith TW. Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25. Review. — View Citation

Dempsey, SF, Khanna, AK, Buhre, W, Saager, L, DiStefano, P, Weingarten, T., Dahan, A., Brazzi, L., Overdyk, F., McIntyre, R. Incidence of Respiratory Depression and Derivation of a Novel Opioid-Induced Respriatory Depression Risk Prediction Tool. Poster presentation. UCLA School of Nursing Research Day, May 14, 2019.

Gupta K, Prasad A, Nagappa M, Wong J, Abrahamyan L, Chung FF. Risk factors for opioid-induced respiratory depression and failure to rescue: a review. Curr Opin Anaesthesiol. 2018 Feb;31(1):110-119. doi: 10.1097/ACO.0000000000000541. Review. — View Citation

Izrailtyan I, Qiu J, Overdyk FJ, Erslon M, Gan TJ. Risk factors for cardiopulmonary and respiratory arrest in medical and surgical hospital patients on opioid analgesics and sedatives. PLoS One. 2018 Mar 22;13(3):e0194553. doi: 10.1371/journal.pone.0194553. eCollection 2018. — View Citation

Jarzyna D, Jungquist CR, Pasero C, Willens JS, Nisbet A, Oakes L, Dempsey SJ, Santangelo D, Polomano RC. American Society for Pain Management Nursing guidelines on monitoring for opioid-induced sedation and respiratory depression. Pain Manag Nurs. 2011 Sep;12(3):118-145.e10. doi: 10.1016/j.pmn.2011.06.008. — View Citation

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 Apr;33(4):383-91. doi: 10.1002/phar.1223. — View Citation

Khanna AK, Sessler DI, Sun Z, Naylor AJ, You J, Hesler BD, Kurz A, Devereaux PJ, Saager L. Using the STOP-BANG questionnaire to predict hypoxaemia in patients recovering from noncardiac surgery: a prospective cohort analysis. Br J Anaesth. 2016 May;116(5):632-40. doi: 10.1093/bja/aew029. — View Citation

Khanna, A, Buhre, W, Saager, L, DiStefano, P, Weingarten, R, Dahan, A, Brazzi, L, & Overdyk, R. Derivation and validation of a novel opioid-induced respiratory depression risk predication tool. Critical Care Medicine 47(1):36, 2019.

Lam T, Nagappa M, Wong J, Singh M, Wong D, Chung F. Continuous Pulse Oximetry and Capnography Monitoring for Postoperative Respiratory Depression and Adverse Events: A Systematic Review and Meta-analysis. Anesth Analg. 2017 Dec;125(6):2019-2029. doi: 10.1213/ANE.0000000000002557. Review. — View Citation

Lee LA, Caplan RA, Stephens LS, Posner KL, Terman GW, Voepel-Lewis T, Domino KB. Postoperative opioid-induced respiratory depression: a closed claims analysis. Anesthesiology. 2015 Mar;122(3):659-65. doi: 10.1097/ALN.0000000000000564. — View Citation

Morrison LJ, Neumar RW, Zimmerman JL, Link MS, Newby LK, McMullan PW Jr, Hoek TV, Halverson CC, Doering L, Peberdy MA, Edelson DP; American Heart Association Emergency Cardiovascular Care Committee, Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on P. Strategies for improving survival after in-hospital cardiac arrest in the United States: 2013 consensus recommendations: a consensus statement from the American Heart Association. Circulation. 2013 Apr 9;127(14):1538-63. doi: 10.1161/CIR.0b013e31828b2770. Epub 2013 Mar 11. — View Citation

Overdyk FJ, Dowling O, Marino J, Qiu J, Chien HL, Erslon M, Morrison N, Harrison B, Dahan A, Gan TJ. Association of Opioids and Sedatives with Increased Risk of In-Hospital Cardiopulmonary Arrest from an Administrative Database. PLoS One. 2016 Feb 25;11(2):e0150214. doi: 10.1371/journal.pone.0150214. eCollection 2016. — View Citation

Perman SM, Stanton E, Soar J, Berg RA, Donnino MW, Mikkelsen ME, Edelson DP, Churpek MM, Yang L, Merchant RM; American Heart Association's Get With the Guidelines®—Resuscitation (formerly the National Registry of Cardiopulmonary Resuscitation) Investigators. Location of In-Hospital Cardiac Arrest in the United States-Variability in Event Rate and Outcomes. J Am Heart Assoc. 2016 Sep 29;5(10). pii: e003638. — View Citation

Ronen M, Weissbrod R, Overdyk FJ, Ajizian S. Smart respiratory monitoring: clinical development and validation of the IPI™ (Integrated Pulmonary Index) algorithm. J Clin Monit Comput. 2017 Apr;31(2):435-442. doi: 10.1007/s10877-016-9851-7. Epub 2016 Mar 9. — View Citation

Safe use of opioids in hospitals. Sentinel Event Alert. 2012 Aug 8;(49):1-5. — View Citation

Stites M, Surprise J, McNiel J, Northrop D, De Ruyter M. Continuous Capnography Reduces the Incidence of Opioid-Induced Respiratory Rescue by Hospital Rapid Resuscitation Team. J Patient Saf. 2017 Jul 20. doi: 10.1097/PTS.0000000000000408. [Epub ahead of print] — View Citation

Sun Z, Sessler DI, Dalton JE, Devereaux PJ, Shahinyan A, Naylor AJ, Hutcherson MT, Finnegan PS, Tandon V, Darvish-Kazem S, Chugh S, Alzayer H, Kurz A. Postoperative Hypoxemia Is Common and Persistent: A Prospective Blinded Observational Study. Anesth Analg. 2015 Sep;121(3):709-15. doi: 10.1213/ANE.0000000000000836. — View Citation

Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010 Feb;112(2):282-7. doi: 10.1097/ALN.0b013e3181ca7a9b. — View Citation

Weingarten TN, Herasevich V, McGlinch MC, Beatty NC, Christensen ED, Hannifan SK, Koenig AE, Klanke J, Zhu X, Gali B, Schroeder DR, Sprung J. Predictors of Delayed Postoperative Respiratory Depression Assessed from Naloxone Administration. Anesth Analg. 2015 Aug;121(2):422-9. doi: 10.1213/ANE.0000000000000792. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sedation	The number of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration ]
Other	Sedation	The percentage of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration ]
Other	Sedation	The characteristics of subjects who experience unintended sedation using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep, increasing numbers represent increasing levels of sedation, and sedation levels 3 or 4 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration ]
Other	Sedation	The number of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Other	Sedation	The percentage of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Other	Sedation	The characteristics of subjects who experience unintended sedation using the Moline Roberts Pharmacologic Sedation Scale in which sedation levels of 1, 2, 3, 4, 5, 6 are assessed where increasing numbers represent increasing levels of sedation and sedation levels 3 or 4 or 5 or 6 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Other	Sedation	The number of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Other	Sedation	The percentage of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Other	Sedation	The characteristics of subjects who experience unintended sedation using the Richmond Agitation Sedation Scale in which sedation levels of +4, +3, +2, +1, 0, -1, -2, -3, -4, -6 are assessed where decreasing numbers represent increasing levels of sedation and sedation levels of -1 or -2 or -3 or -4 or -5 indicate unintended opioid-induced sedation for the purpose of this study	Change from baseline assessment observed within 60 minutes after opioid administration
Primary	Hypoventilation	The number of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration
Primary	Hypoventilation	The percentage of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration
Primary	Hypoventilation	The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration
Secondary	Hypoxemia	The number of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration ]
Secondary	Hypoxemia	The percentage of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration ]
Secondary	Hypoxemia	The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.	Change from baseline measurement observed within 60 minutes after opioid administration ]