SAVE-O2 AI Trial

No randomized trial of autonomous oxygen titration in non-ventilated patients has previously been conducted in the United States. Trial enrollment began May 6, 2024, and the trial is registered at ClinicalTrials.gov as NCT06374225. Although the trial is open-label for patients and clinicians, outcome assessments are performed by physicians and statisticians blinded to group allocation. Both the University of Colorado (Clinical Coordinating Centre) and Vanderbilt University Medical Center (Data Coordinating Centre) serve as coordinating centers for the trial. Eligible patients must be adults aged 18 or older who can be randomized within 36 hours of hospital arrival and are receiving supplemental oxygen at 1–10 L/min. SAVE-O2 AI is a multicentre, open-label, parallel-group RCT at four US level 1 trauma and tertiary care hospitals.