NCT07224243

Impact of Intraoperative Oxygenation Practices on Patient Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 54,000 (estimated)
• Sponsor: Frederic T Billings IV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 endpoint, surgical site infection, length of stay, and hypoxemia. The study is conducted under a waiver of informed consent due to minimal incremental risk of participating and impracticability of obtaining consent in this cluster-randomized design.

Conditions

• Surgeries Undergoing General Anesthesia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-02-01
• Completion: 2028-04-01
• First posted: 2025-11-04
• Last updated: 2026-04-07

Locations

4 sites across 1 country: United States