NCT06227208

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 691 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-01-01
• Completion: 2024-01-16
• First posted: 2024-01-26
• Last updated: 2024-01-26

Locations

2 sites across 1 country: Denmark

Regulatory

• FDA-regulated device study