Impact of Intraoperative Oxygenation Practices on Patient Outcomes

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.

Description

The Intraop Ox trial will enroll adult patients undergoing surgery with tracheal intubation. Participating hospitals will be randomly assigned (as a unit) to administer one of three oxygenation strategies during maintenance anesthesia (lower FiO₂ \[0.21-0.40\], intermediate FiO₂ \[0.40-0.80\], or higher \[FiO₂ 0.80-1.00\] each period (month). The primary outcome is a composite of organ injury (acute kidney injury, myocardial injury, lung injury, stroke) or death within 30 days. Secondary outcome is 30-day mortality. Exploratory outcomes are individual components of the composite primary endpoi…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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-l…

Interventions

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

Locations (4)

University of Michigan Hospital
Ann Arbor, Michigan
repantis@med.umich.edu 734-834-8318
Nebraska Medical Center
Omaha, Nebraska
emsanchezrodriguez@unmc.edu 402-559-8299
Vanderbilt University Medical Center
Nashville, Tennessee
tracie.d.baker@vumc.org 6158751852
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah
Anne.mackey@utah.edu 801-580-6886