Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Frederic T Billings IV
54,000 participants
Dec 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Patient located in a participating operating room
- Planned surgery includes tracheal intubation
Exclusion Criteria9
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner.
- Patient is American Society of Anesthesiologists (ASA) classification-6 (i.e., organ donor)
- Patient's planned surgical case includes open heart surgery, defined as surgery on the heart or ascending aorta requiring sternotomy or thoracotomy.
- Patient's planned procedure requires prolonged apnea, bronchoscopy, airway surgery, or one-lung ventilation.
- Patient's planned surgical case includes use of extracorporeal membrane oxygenation (ECMO).
- Patient is known to have a history of bleomycin treatment.
- Patient was enrolled in the trial in the prior 30 days.
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Interventions
FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07224243