Prevention of Opioid-Induced Hypoxemia

Non-cardiac Surgery Clinical Trial

Official title:

Wearable Device for Prevention of Opioid-Induced Hypoxemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04453722
• Other study ID #: 20-505
• Secondary ID: 1R43DA050336-01A
• Status: Active, not recruiting
• Start date: June 26, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 49
• Est. completion date: December 30, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypoxia
• Non-cardiac Surgery

Intervention

Device:
• Oxalert Monitor Mode
The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
• Oxalert Normal mode
The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Average of SpO2 Below a Threshold of 90%	Time-weighted average of SpO2 below a threshold of 90%. Oxygen Saturation measured between 0% - 100%. Oxygen Saturation <90% is considered abnormal.	during hospitalization up to 6 days and post-discharge 24 hours
Primary	Number of Participants With Desaturation Events (Saturation <90%) Lasting at Least 2 Min	Number of Participants with Desaturation Events (Saturation <90%) Lasting at Least 2 Min. All the patients were included.	during hospitalization up to 6 days and post-discharge 24 hours
Primary	Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Min	Duration of Desaturation Events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included.	during hospitalization up to 6 days and post-discharge 24 hours
Primary	AUC of SpO2 Below a Threshold of 90%	AUC of SpO2 Below a Threshold of 90%. SpO2 from 0% -100%.	during hospitalization up to 6 days and post-discharge 24 hours
Primary	Number of Desaturation Events (Saturation <90%) Lasting at Least 2 Min	Number of desaturation events (Saturation <90%) Lasting at Least 2 Mi. All desaturation events were included.	during hospitalization up to 6 days and post-discharge 24 hours
Secondary	Patients' Attitude Toward the Device	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.	At the day of discharge and after 24 hours of discharge
Secondary	Nurses' Attitude Toward the Device	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).	Post-operative day 1 (POD 1)