Clinical trial NCT04453722: Prevention of Opioid-Induced Hypoxemia
Official title: Wearable Device for Prevention of Opioid-Induced Hypoxemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-cardiac Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-07-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators will enroll patients who are at increased risk for respiratory insufficiency. Specifically, the investigators will focus on patients scheduled for laparoscopic or open major abdominal or pelvic surgery whose analgesia is primarily opioid-based. The investigators will further restrict enrollment to obese patients (body mass index kg/m2) who are likely to have respiratory compromise. Both men and women will be recruited.

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 (no alerts), throughout hospitalization up to six days, and for 24 post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal mode which provides progressive audible and tactile alerts for hypoxemia.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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).

Primary outcomes:
measure: Time-weighted Average of SpO2 Below a Threshold of 90%
timeFrame: during hospitalization up to 6 days and post-discharge 24 hours
measure: Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min
timeFrame: during hospitalization up to 6 days and post-discharge 24 hours
measure: Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
timeFrame: during hospitalization up to 6 days and post-discharge 24 hours
measure: AUC of SpO2 Below a Threshold of 90%
timeFrame: during hospitalization up to 6 days and post-discharge 24 hours
measure: Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min
timeFrame: during hospitalization up to 6 days and post-discharge 24 hours
Secondary outcomes:
measure: Patients' Attitude Toward the Device
timeFrame: At the day of discharge and after 24 hours of discharge
measure: Nurses' Attitude Toward the Device
timeFrame: Post-operative day 1 (POD 1)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel Sessler, MD
role: PRINCIPAL_INVESTIGATOR
References: