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

Medical Complication Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06227208
• Other study ID #: WARD-postoperative-opioid
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: January 16, 2024

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 691
• Est. completion date: January 16, 2024
• Est. primary completion date: January 1, 2024
• Gender: All
• Age group: 50 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Medical Complication
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SpO2 <88% in the four hours following opioid administration		four hours following opioid administration
Secondary	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