Status:
COMPLETED
Prevention of Opioid-Induced Hypoxemia
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Non-cardiac Surgery
Eligibility:
All Genders
18-85 years
Brief Summary
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
Detailed Description
The investigators will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the monitoring only mode (...
Eligibility Criteria
Inclusion
- Adults having major laparoscopic and open abdominal or pelvic surgeries;
- Body Mass Index ≥25 kg/m2
- American Society of Anesthesiologists physical status 1-3;
- Age 18-85 years old;
- Able to understand and consent to the trial and fully participate;
- Anticipated primary opioid analgesia after surgery;
- Expected duration of hospitalization at least 24 hours after surgery;
- Consenting at least 24 hours before anticipated surgery.
Exclusion
- Epidural analgesia (field and fascial plane blocks permitted);
- Pre-operative SpO2 \<95%;
- No wrist available for the study;
- Severe hearing loss;
- Lack of English language fluency.
- Serious hearing deficit (unable to understand normal speech in a quite environment)
- Serious peripheral neuropathy (unable to feel pin prick at wrist).
Key Trial Info
Start Date :
June 26 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04453722
Start Date
June 26 2020
End Date
June 15 2023
Last Update
August 29 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195