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Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention
Sponsor: University of Colorado, Denver
Summary
This study is a multicenter randomized controlled trial to determine the effectiveness of a closed loop/autonomous oxygen titration system (O2matic PRO100) to maintain normoxemia (goal range SpO2 90-96%, target 93%) during the first 72 hours of acute injury or illness, compared to standard provider-driven methods (manual titration with SpO2 target of 90-96%).
Official title: Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-04-29
Completion Date
2026-05-01
Last Updated
2025-12-15
Healthy Volunteers
No
Interventions
Automated Titration (O2matic)
The patient will receive supplemental oxygen titrated using an autonomous oxygen titration device. The patient will be monitored and vital signs documented by the site's usual SpO2 assessments, but oxygen titration will occur automatically through the O2matic PRO100 device during the intervention period, unless there is a safety concern. The SpO2 range programmed into the PRO100 is 92-94%. The acceptable SpO2 range for the protocol is 90-96%. If a patient requires \>15lpm or other signs of advancing respiratory failure, they will be taken off the autonomous oxygen and transitioned to higher flow oxygen devices or mechanical ventilation per usual clinical care. If the patient is not receiving any supplemental oxygen per the autonomous titration, the clinical team may remove the oxygen delivery device from the patient, but the patient should remain connected to the PRO100 for the duration of the intervention period for data collection and to monitor for new supplemental oxygen needs.
Locations (4)
University of Colorado
Aurora, Colorado, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Oregon Health and Sciences University
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States