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

NCT ID: NCT06227208

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 691 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-01-16

Brief Summary

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

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%.

Conditions

Medical Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

Continuous vital sign monitoring

Intervention Type: DEVICE

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.

Continuous vital sign monitoring

Intervention Type: DEVICE

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.

Continuous vital sign monitoring

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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%

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Eske Kvanner Aasvang

Professor, head of research, MD, DmSci

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eske Kvanner Aasvang, Professor

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

Rigshospitalet

Copenhagen, , Denmark

Bispebjerg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

WARD-postoperative-opioid

Identifier Type: -

Identifier Source: org_study_id