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Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Sponsor: Frederic T Billings IV
Summary
This multicenter, cluster-randomized, cluster-crossover clinical trial evaluates the impact of three intraoperative FiO2 (Fraction of Inspired Oxygen) oxygenation strategies-lower (FiO₂ 0.21-0.40), intermediate (FiO₂ 0.40-0.80), and higher (FiO₂ 0.80-1.00)-on postoperative organ injury and mortality in adult surgical patients. The trial aims to determine the optimal oxygenation strategy to improve perioperative outcomes.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54000
Start Date
2025-12-01
Completion Date
2028-04
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Lower FiO2
FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
Intermediate FiO2
FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
Higher FiO2
FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia
Locations (4)
University of Michigan Hospital
Ann Arbor, Michigan, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States