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

Withdrawn

• Conditions: Respiratory Depression; Sedation

• Registration Number: NCT03647696
• Lead Sponsor: Poudre Valley Health System

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2018-08-30
• Primary Completion: 2018-08-30
• Study Completion: 2018-08-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoventilation	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)

Secondary Outcome Measures

Name	Time	Method
Hypoxemia	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)