Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Recruiting now · Not applicable

Conditions studied: Surgeries Undergoing General Anesthesia

In brief

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 facts

Study ID

NCT07224243

Run by

Frederic T Billings IV

People needed

54000

Starts

2025-12-01

Expected to finish

2028-04-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient located in a participating operating room
• Planned surgery includes tracheal intubation

You may not qualify if…

• 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.

Where it is running

• Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• University of Michigan Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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