Medical ComplicationNCT06227208
Postoperative Opioid and Respiratory Depression in Opioid Naive and Chronic Opioid Patients
An observational study of Medical Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Medical Complication
- What is being tested?
- Continuous vital sign monitoring
- Type of treatment
- Medical device
- How many people
- 691 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Oct 2023to 16 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients from studies WARD Surgery Observational [gov: NCT03491137]
- The control group from WARD Surgery Randomized Controlled Trial [gov: NCT04640415]
Who cannot join
- 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%
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Rigshospitalet
Copenhagen, 2100
Bispebjerg Hospital
Copenhagen, 2400
About this study
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.
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
Read the 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
- Being tested
- Continuous vital sign monitoring
- Keywords
- Opioid-induced respiratory depression, Postoperative opioid, Opioid-naïve patients, Chronic opioid patients, Desaturation, Bradypnea, Continuous monitoring, Patient safety
- Medical subject headings
- Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous vital sign monitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Continuous vital sign monitoring | |
| Control group | Patients who did not receive pre- or postoperative opioids were served as the overall control group. Receives: Device: Continuous vital sign monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 <88% in the four hours following opioid administration
Measured: four hours following opioid administration
Secondary outcomes (1)
Respiratory deviations four hours after opioid administration
SpO2 <92%, <88 %, <85%, <80% and respiratory rate ≤11 min-1, ≤8 min-1, ≤5 min-1
Measured: four hours following opioid administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical ComplicationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 691 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Eske Kvanner Aasvang, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Eske Kvanner Aasvang, Professor, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227208
- Sponsor's protocol ID
- WARD-postoperative-opioid
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06227208
- Acronym / sponsor ID
- WARD-postoperative-opioid
- Conditions
- Medical Complication
- Keywords
- Opioid-induced respiratory depression, Postoperative opioid, Opioid-naïve patients, Chronic opioid patients, Desaturation, Bradypnea, Continuous monitoring, Patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 691 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opioid-naive patients | – | Device: Continuous vital sign monitoringOpioid-naive patients are defined as the absence of any documented opioid use in the available preoperatively medical records, and are receiving opioids postoperatively |
| Chronic opioid patients | – | Device: Continuous vital sign monitoringChronic 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. |
| Control group | – | Device: Continuous vital sign monitoringPatients who did not receive pre- or postoperative opioids were served as the overall control group. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients from studies WARD Surgery Observational [gov: NCT03491137]
- The control group from WARD Surgery Randomized Controlled Trial [gov: NCT04640415]
Key exclusion criteria (5 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous vital sign monitoringWireless 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. | Device | Chronic opioid patients, Control group, Opioid-naive patients |
Primary outcome
SpO2 <88% in the four hours following opioid administration
Time frame: four hours following opioid administration
1 secondary outcome
Respiratory deviations four hours after opioid administration
Time frame: four hours following opioid administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eske Kvanner Aasvang, Professor study chair
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Complication, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 <88% in the four hours following opioid administration (time frame: four hours following opioid administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2024.