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

June 9, 2021 updated by: Poudre Valley Health System

Incidence of Opioid-induced Respiratory Depression in Medical and Trauma Patients on the General Care Floor Receiving Patient-controlled Analgesia and Nurse Administered Intravenous Opioids Monitored by Capnography and Pulse Oximetry: A Prospective, Blinded Observational Study

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoventilation
Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoxemia
Time Frame: Change from baseline measurement observed within 60 minutes after opioid administration
Continuous respiratory monitoring using pulse oximetry will be performed for collecting data of oxygen saturation (SpO2)
Change from baseline measurement observed within 60 minutes after opioid administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation
Time Frame: Change from baseline assessment observed within 60 minutes after opioid administration
Sedation assessment will be preformed 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
Sedation
Time Frame: Change from baseline assessment observed with 60 minutes after opioid administration
Sedation assessment will be preformed using the Pasero Opioid-Induced Sedation Scale in which sedation levels of S, 1, 2, 3, 4 are assessed where "S" represents normal sleep and 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 with 60 minutes after opioid administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poudre Valley Health System

Collaborators

University of California, Los Angeles
Medtronic
University of Colorado Health

Investigators

  • Principal Investigator: Susan J Dempsey, PhD(c), UCLA and UCHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2018

Primary Completion (Actual)

August 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 23, 2018

First Posted (Actual)

August 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PoudreVHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not decided whether the data will be available for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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