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Impact of Oxygen Levels During Surgery on Patient Outcomes

This study is looking at how different levels of oxygen given during general anesthesia (when you're asleep for surgery) affect patient outcomes. Researchers are comparing three oxygen strategies: lower (FiO₂ 0.21-0.40), intermediate (FiO₂ 0.40-0.80), and higher (FiO₂ > 0.80) oxygen. The goal is to find the best oxygen level to reduce organ injury or death within 30 days after surgery. You might be able to join if you are 18 or older, having surgery that requires a breathing tube, and are at a participating hospital. The study is currently unclear on its status and plans to enroll 54,000 people.

Study design
This is a large, multicenter study where hospitals are randomly assigned to use one of three oxygen strategies for a month at a time. It involves adult patients undergoing surgery with tracheal intubation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Patients will be followed for 30 days after surgery to check for organ injury or death.

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NCT07224243

Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Recruiting
NAAges 18+InterventionalTreatment
Frederic T Billings IV
~54,000 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:Lower FiO2Intermediate FiO2Higher FiO2

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite of organ injury or in-hospital death within 30 days of surgery
Measured over 30 days post-surgery

Conditions

Surgeries Undergoing General Anesthesia

Explore related trials

Surgical Procedure

Where it's being run

4 sites across 4 states
Michigan1
Nebraska1
Tennessee1
Utah1

Study leadership

  • Frederic T Billings, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Tracie Baker, CCRA
[email protected]
6158751852
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient located in a participating operating room
Planned surgery includes tracheal intubation

Exclusion

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.

What this trial measures

  • Composite of organ injury or in-hospital death within 30 days of surgery30 days post-surgery

    This composite outcome measures the number of participants experiencing at least one of the following organ injuries or death within the defined study period: * Acute Kidney Injury (AKI), defined according to creatinine based Kidney Disease Improving Global Outcomes criteria, specifically a 0.3 mg/dL or greater increase within 48 hours or a 50% or greater increase from baseline within seven days of surgery. * Myocardial injury, defined as \>99th percentile of normal based on site-specific troponin assay within 72 hours of surgery. * Lung injury, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes * Stroke, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes * Death within 30 days of surgery