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

NCT06227208 | Completed FDA Device

• 1 other identifier: WARD-postoperative-opioid
• Study Type: observational
• Target: 691
• Locations: 1 country
• Sites: 2

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

Conditions

Medical Complication

Keywords

Opioid-induced respiratory depression; Postoperative opioid; Opioid-naïve patients; Chronic opioid patients; Desaturation; Bradypnea; Continuous monitoring; Patient safety

Outcome Measures

Primary Outcomes (1)

• SpO2 <88% in the four hours following opioid administration

  four hours following opioid administration

Secondary Outcomes (1)

• Respiratory deviations four hours after opioid administration

  four hours following opioid administration

Study Arms (3)

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

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

Control group

Patients who did not receive pre- or postoperative opioids were served as the overall control group.

Device: Continuous vital sign monitoring

Interventions

Continuous vital sign monitoring 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; Control group; Opioid-naive patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Bispebjerg Hospital: collaborator

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Hypoventilation

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eske Kvanner Aasvang, Professor

  Rigshospitalet, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, head of research, MD, DmSci

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: October 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 16, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

DK (2)