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Completed

NCT Number: NCT06227208

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

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

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Key information

Conditions

Medical Complication Hypoventilation Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

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%.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Primary outcomes

  1. SpO2 <88% in the four hours following opioid administration

    Time frame: four hours following opioid administration

Secondary outcomes

  1. Respiratory deviations four hours after opioid administration

    Time frame: four hours following opioid administration

    SpO2 <92%, <88 %, <85%, <80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study 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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2024
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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