Prevention of Opioid-Induced Hypoxemia

Active, not recruiting

• Conditions: Non-cardiac Surgery
• Interventions: Device: Oxalert Monitor Mode; Device: Oxalert Normal mode

• Registration Number: NCT04453722
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study Start: 2020-06-26
• Study First Submitted QC: 2020-06-26
• Study First Posted: 2020-07-01
• Primary Completion: 2022-04-30
• Results First Submitted: 2023-08-02
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Results First Posted: 2024-02-20
• Last Update Posted: 2024-02-20
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Monitor only mode	Oxalert Monitor Mode	Randomization will be to Oxalert in monitor-only mode
Monitor in normal mode	Oxalert Normal mode	Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.

Primary Outcome Measures

Name	Time	Method
AUC of SpO2 Below a Threshold of 90%	during hospitalization up to 6 days and post-discharge 24 hours	AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%.
Time-weighted Average of SpO2 Below a Threshold of 90%	during hospitalization up to 6 days and post-discharge 24 hours	Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation \<90% is considered abnormal.
Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min	during hospitalization up to 6 days and post-discharge 24 hours	Duration of Desaturation Events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.
Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min	during hospitalization up to 6 days and post-discharge 24 hours	Number of Participants with Desaturation Events (Saturation \<90%) Lasting at Least 2 Min. All the patients were included.
Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min	during hospitalization up to 6 days and post-discharge 24 hours	Number of desaturation events (Saturation \<90%) Lasting at Least 2 Mi. All desaturation events were included.

Secondary Outcome Measures

Name	Time	Method
Nurses' Attitude Toward the Device	Post-operative day 1 (POD 1)	We used 0-to-10 (better- worst) numerical rating scale to measure the degree of disturbing: 0 = "Not disturbed" and 10 = "Severely disturbed"; others are measured with 5-point numerical rating scales:1="Strongly disagree", 5="Strongly agree" (1= better- 5=worst).
Patients' Attitude Toward the Device	At the day of discharge and after 24 hours of discharge	We used 0-to-10 (Better - Worst) numerical rating scale to measure the degree of disturbing: 0 = "Not disturbed" and 10 = "Severely disturbed"; others are measured with 5-point numerical rating scales:1="Strongly disagree", 5="Strongly agree" (1=Better - 5= Worst). No subscales combining to compute a total score.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States