Prevention of Opioid-Induced Hypoxemia

NCT04453722 | Completed Results DMC

• 2 other identifiers: 20-5051R43DA050336-01A1
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-cardiac Surgery

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Patients' Attitude Toward the Device

  At the day of discharge and after 24 hours of discharge

• Nurses' Attitude Toward the Device

  Post-operative day 1 (POD 1)

Study Arms (2)

Monitor only mode

Randomization will be to Oxalert in monitor-only mode

Device: Oxalert Monitor 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

Interventions

Oxalert Monitor Mode DEVICE

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.

Monitor only mode

Oxalert Normal mode DEVICE

The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode

Monitor in normal mode

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Li K, Saab R, Bravo M, Mascha EJ, Han Y, Nault R, Olson L, Sessler DI. Wearable device for prevention of postoperative and post-discharge hypoxemia: A randomized pilot trial. Acta Anaesthesiol Scand. 2023 Apr;67(4):440-447. doi: 10.1111/aas.14193. Epub 2023 Jan 13.

  PMID: 36583643 DERIVED

Results Point of Contact

• Title: Daniel I. Sessler, Professor & Chair
• Organization: Cleveland Clinic

DS@CCF.org

216-445-6500

Study Officials

• Daniel Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 1, 2020
• Study Start: June 26, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 15, 2023
• Last Updated: August 29, 2025
• Results First Posted: February 20, 2024

Record last verified: 2025-08

Locations

US (1)