Prevention of Opioid-Induced Hypoxemia

Wearable Device for Prevention of Opioid-Induced Hypoxemia

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-cardiac Surgery
• Intervention / Treatment: Device: Oxalert Monitor Mode; Device: Oxalert Normal mode

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 Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Monitor only mode; Randomization will be to Oxalert in monitor-only mode	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.
Monitor in normal mode; Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Daniel Sessler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 26, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 20-505; 1R43DA050336-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes