Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients

NCT03647696 | Withdrawn

• 1 other identifier: PoudreVHS
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 (IV) 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.

Conditions

Respiratory Depression; Sedation

Keywords

respiratory depression, opioid-induced sedation

Outcome Measures

Primary Outcomes (1)

• Hypoventilation

  Continuous respiratory monitoring using capnography will be performed for collecting data of end-tidal carbon dioxide (etCO2)

  Change from baseline measurement observed within 60 minutes after opioid administration

Secondary Outcomes (1)

• Hypoxemia

  Change from baseline measurement observed within 60 minutes after opioid administration

Other Outcomes (2)

• Sedation

  Change from baseline assessment observed within 60 minutes after opioid administration

• Sedation

  Change from baseline assessment observed with 60 minutes after opioid administration

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target study population will be hospitalized, adult medical or trauma patients on the general care floor receiving PCA or nurse administered IV opioids for acute pain.

You may qualify if:

• Spontaneously breathing adults 18 to 89 years of age
• English speaking
• Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
• Admitted to the general care floor from the emergency department

You may not qualify if:

• Less than 18 or greater than 89 years of age
• Transfer to the general care floor from the Intensive Care Unit
• Receiving intrathecal or epidural opioids
• Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
• History or diagnosis of a sleep disordered breathing syndrome
• Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
• Receiving non-invasive ventilation
• Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
• Unwilling or unable to participate
• Member of a vulnerable population such as pregnant women or prisoners.

Sponsors & Collaborators

• Poudre Valley Health System: lead
• University of Colorado Health: collaborator
• University of California, Los Angeles: collaborator
• Medtronic: collaborator

Related Publications (14)

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  PMID: 26287299 BACKGROUND

• 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. 2021 Sep 1;17(6):e557-e561. doi: 10.1097/PTS.0000000000000408.

  PMID: 28731933 BACKGROUND

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  PMID: 27688235 BACKGROUND

• Churpek MM, Yuen TC, Huber MT, Park SY, Hall JB, Edelson DP. Predicting cardiac arrest on the wards: a nested case-control study. Chest. 2012 May;141(5):1170-1176. doi: 10.1378/chest.11-1301. Epub 2011 Nov 3.

  PMID: 22052772 BACKGROUND

• Andersen LW, Berg KM, Chase M, Cocchi MN, Massaro J, Donnino MW; American Heart Association's Get With The Guidelines((R))-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.

  PMID: 27255952 BACKGROUND

• 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.

  PMID: 25536092 BACKGROUND

• 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.

  PMID: 21893302 BACKGROUND

• 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.

  PMID: 20098128 BACKGROUND

• Taenzer AH, Pyke J, Herrick MD, Dodds TM, McGrath SP. A comparison of oxygen saturation data in inpatients with low oxygen saturation using automated continuous monitoring and intermittent manual data charting. Anesth Analg. 2014 Feb;118(2):326-331. doi: 10.1213/ANE.0000000000000049.

  PMID: 24361847 BACKGROUND

• Davis C, Geik C, Arthur K, Fuller J, Johnston E, Levitt F, Leung E, McCart G, McMichael D, Painter J, Staublin T, Walroth T. A Multisite Retrospective Study Evaluating the Implementation of the Pasero Opioid-Induced Sedation Scale (POSS) and Its Effect on Patient Safety Outcomes. Pain Manag Nurs. 2017 Aug;18(4):193-201. doi: 10.1016/j.pmn.2017.03.006. Epub 2017 Jun 9.

  PMID: 28606595 BACKGROUND

• Morris TA, Gay PC, MacIntyre NR, Hess DR, Hanneman SK, Lamberti JP, Doherty DE, Chang L, Seckel MA. Respiratory Compromise as a New Paradigm for the Care of Vulnerable Hospitalized Patients. Respir Care. 2017 Apr;62(4):497-512. doi: 10.4187/respcare.05021.

  PMID: 28341777 BACKGROUND

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  PMID: 22504472 BACKGROUND

• 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 Aug;105(2):412-8. doi: 10.1213/01.ane.0000269489.26048.63.

  PMID: 17646499 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Susan J Dempsey, PhD(c)

  UCLA and UCHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 27, 2018
• Study Start: August 30, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: June 11, 2021

Record last verified: 2021-06