Incidence of Opioid-Induced Respiratory Depression in Medical and Trauma Patients
NCT ID: NCT03647696
Last Updated: 2021-06-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Study Classification
OBSERVATIONAL
Study Start Date
2018-08-30
Study Completion Date
2018-08-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Respiratory Depression
Sedation
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
1. Spontaneously breathing adults 18 to 89 years of age
2. English speaking
3. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
4. Admitted to the general care floor from the emergency department
2. English speaking
3. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
4. Admitted to the general care floor from the emergency department
Exclusion Criteria
1. Less than 18 or greater than 89 years of age
2. Transfer to the general care floor from the Intensive Care Unit
3. Receiving intrathecal or epidural opioids
4. Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
5. History or diagnosis of a sleep disordered breathing syndrome
6. Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
7. Receiving non-invasive ventilation
8. Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
9. Unwilling or unable to participate
10. Member of a vulnerable population such as pregnant women or prisoners.
2. Transfer to the general care floor from the Intensive Care Unit
3. Receiving intrathecal or epidural opioids
4. Inability or unwillingness to wear the etCO2 sampling line nasal cannula or pulse oximetry sensor
5. History or diagnosis of a sleep disordered breathing syndrome
6. Use of Continuous Positive Airway Pressure or (CPAP) or Bilevel Positive Airway Pressure (BIPAP) non-invasive ventilation as home regime
7. Receiving non-invasive ventilation
8. Presence of a co-morbidity that impacts respiration or ventilation (e.g Chronic Obstructive Pulmonary Disease or Pulmonary Fibrosis)
9. Unwilling or unable to participate
10. Member of a vulnerable population such as pregnant women or prisoners.
Minimum Eligible Age
18 Years
Maximum Eligible Age
89 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Colorado Health
OTHER
Sponsor Role
collaborator
University of California, Los Angeles
OTHER
Sponsor Role
collaborator
Medtronic
INDUSTRY
Sponsor Role
collaborator
Poudre Valley Health System
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Susan J Dempsey, PhD(c)
Role: PRINCIPAL_INVESTIGATOR
UCLA and UCHealth
References
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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):709-715. doi: 10.1213/ANE.0000000000000836.
Reference Type
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.
Reference Type
BACKGROUND
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(R)-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):e003638. doi: 10.1161/JAHA.116.003638.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Henneman EA, Gawlinski A, Giuliano KK. Surveillance: A strategy for improving patient safety in acute and critical care units. Crit Care Nurse. 2012 Apr;32(2):e9-18. doi: 10.4037/ccn2012166.
Reference Type
BACKGROUND
Moline B, Roberts M, Houser J. Validity and interrater reliability of the Moline-Roberts Pharmacologic Sedation Scale. Clin Nurse Spec. 2012 May-Jun;26(3):140-8. doi: 10.1097/NUR.0b013e3182503fd6.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
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PoudreVHS
Identifier Type: -
Identifier Source: org_study_id
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