Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention

Study acronym: SAVE-O2 AI
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Results posted: Oct 14, 2026 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (4)
    • Publications: details revised at 2 of 2 entries
    • Study description shortened, about 4 words
  2. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of May 1, 2026 to Jan 9, 2026
    v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 31, 2025 to Dec 7, 2025
    • Site details revised at 4 of 4 sites
    v5
  4. Study sites: 3 to 4
    • Eligibility criteria revised
    v4
  5. Site details revised at 1 of 3 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2024 to Apr 29, 2024
    • Site details revised at 3 of 3 sites
    • Study description expanded, about 5 words
    v2
  7. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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%).
Trial Details
NCT Number NCT06374225
Lead Sponsor University of Colorado, Denver
Collaborators: United States Department of Defense, O2matic ApS, IDTS Medical, Inc.
Conditions
(from sponsor)		 Critical Illness, Wounds and Injury, Disease Attributes, Pathologic Processes
Related terms Burns, Critical Illness, Disease Attributes, Hyperoxia, Hypoxia, Pathologic Processes, Wounds and Injuries
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov