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RECRUITING Not applicable ClinicalTrials.gov

Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Sponsor: Frederic T Billings IV • ClinicalTrials.gov ID: NCT07224243

Registry updated: 2026-09-16
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Description

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.

Interventions

  • Lower FiO2 (Other)
    FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
  • Intermediate FiO2 (Other)
    FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
  • Higher FiO2 (Other)
    FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia

Eligibility criteria

Inclusion Criteria: * Patient located in a participating operating room * Planned surgery includes tracheal intubation Exclusion Criteria: * 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.

Conditions

Surgeries Undergoing General Anesthesia

Locations

  • 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record