NCT04453722

Prevention of Opioid-Induced Hypoxemia

Wearable Device for Prevention of Opioid-Induced Hypoxemia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-cardiac Surgery

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2020-06-26
• Primary completion: 2022-04-30
• Completion: 2023-06-15
• First posted: 2020-07-01
• Last updated: 2025-08-29
• Results posted: 2024-02-20

Locations

1 site across 1 country: United States