Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients

The Impact of Postoperative Opioids on Duration and Severity of Desaturation and Bradypnea in Opioid-naïve and Chronic Opioid Patients, Assessed by Continuous Vital Sign Monitoring.

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients. Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Outcome: Respiratory deviations four hours after opioid administration

Study Overview

• Status: Completed
• Conditions: Medical Complication
• Intervention / Treatment: Device: Continuous vital sign monitoring

Detailed Description

Aim: To describe the duration of desaturation and bradypnea in postoperative opioid-naïve and chronic opioid patients within the first four hours following opioid administration in addition to the chronic dose, using a continuously wireless monitoring system.

Patients: 691 patients included from two previous WARD (Wireless Assessment of Respiratory and circulatory Distress) projects. Continuous wireless monitoring data of peripheral tissue oxygenation (SpO2) and respiratory rate (RR) was conducted in postoperative patients. Data were stratified into opioid-naïve and chronic opioid patients, based on their preoperative opioid history. Patients who did not receive opioids postoperatively were served as the control group. Data was evaluated one hour before and four hours after opioid administration. The primary outcome was the cumulative duration of SpO2 <88%.

• Study Type: Observational
• Enrollment (Actual): 691

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients from studies WARD Surgery Observational [gov: NCT03491137] and the control group from a WARD Surgery Randomized Controlled Trial (RCT) [gov: NCT04640415 - submitted] were assessed for inclusion eligibility.

Description

Inclusion Criteria:

• Patients from studies WARD Surgery Observational [gov: NCT03491137]
• The control group from WARD Surgery Randomized Controlled Trial [gov: NCT04640415]

Exclusion Criteria:

• Less than 30 minutes of continuous monitoring data within the 60-minute window prior to opioid administration
• Less than 120 minutes (<50% of theoretical maximum) of monitoring data available during the four-hour observation period
• Patients who received transdermal fentanyl as postoperative opioid
• Patients with a baseline saturation or respiratory rate below the prespecified thresholds
• Patients with a BMI of ≥40 or diagnosed with COPD were excluded in the analysis of SpO2 <92%

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opioid-naive patients; Opioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively	Device: Continuous vital sign monitoring; Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter.
Chronic opioid patients; Chronic opioid patients were defined as current or previous use of the following medications, re-gardless of the duration of use: morphine, tramadol, tapentadol, fentanyl, oxycodone, ketobe-midone, methadone, or buprenorphine. This was verified through patients' preoperative medical records. All chronic opioid users received postoperative opioids.	Device: Continuous vital sign monitoring; Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter.
Control group; Patients who did not receive pre- or postoperative opioids were served as the overall control group.	Device: Continuous vital sign monitoring; Wireless monitoring system that provided continuous, non-invasive collection of their vital signs, including peripheral oxygen saturation (SpO2) and respiratory rate (RR), for up to 92 hours following surgery or until discharge. The respiratory rate was monitored via FDA-approved Isansys Lifetouch electrocardiogram (ECG) patch, which was placed on the left side of the chest. SpO2 levels were continuously recorded using the Nonin WristOx 3150, a wrist-mounted finger oximeter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
SpO2 <88% in the four hours following opioid administration	four hours following opioid administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory deviations four hours after opioid administration	SpO2 <92%, <88 %, <85%, <80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1	four hours following opioid administration

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Bispebjerg Hospital
• Investigators: Study Chair: Eske Kvanner Aasvang, Professor, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): January 16, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Estimated): January 26, 2024

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Patient safety; Desaturation; Continuous monitoring; Opioid-induced respiratory depression; Postoperative opioid; Opioid-naïve patients; Chronic opioid patients; Bradypnea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: WARD-postoperative-opioid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No