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Impact of Intraoperative Oxygenation Practices on Patient Outcomes

NCT07224243 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54000

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Surgeries Undergoing General Anesthesia

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

Sponsors & Collaborators

  • Multicenter Perioperative Outcomes Group

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • The Association of University Anesthesiologists

    collaborator UNKNOWN

  • Frederic T Billings IV

    lead OTHER

Principal Investigators

  • Frederic T Billings, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-02-29
Completion
2028-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224243 on ClinicalTrials.gov