Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Conditions

• Surgeries Undergoing General Anesthesia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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 Dates

Start date

Dec 1, 2025

Status verified

Jun 2026

Primary completion

Feb 29, 2028

Completion

Apr 30, 2028

Study Design

Enrollment

54,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Lower FiO2
• Experimental: Intermediate FiO2
• Experimental: Higher FiO2

Primary Outcome Measure

Composite of organ injury or in-hospital death within 30 days of surgery [ Time Frame: 30 days post-surgery ]

Central Contacts

• Tracie Baker, CCRA
  6158751852
  [email protected]

Locations (4)

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