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Clinical trial Recruiting at 4 sites Interventional Ages 18 and up

Intraoperative oxygen levels and postoperative outcomes in adults

Official title: Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Run by Vanderbilt University Medical Center · NCT07224243 · Data updated 2026-11-12

This project will try three different amounts of oxygen during general anesthesia to see which one leads to fewer organ injuries or deaths in adults having surgery with a breathing tube.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment54000 (estimated)
SponsorVanderbilt University Medical Center
Academic / other
Locations4 sites (Ann Arbor, Michigan and 3 other locations)
StatusRecruiting
StartedDecember 1, 2025
Main results expectedFebruary 2028
Study endsApril 2028
Registry record updatedSeptember 16, 2026
Trial IDNCT07224243 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) undergoing surgery with planned tracheal intubation at participating hospitals who do not meet exclusion criteria are the intended participants.

Probably not a fit

Patients who are under 18, pregnant, prisoners, ASA-6 organ donors, undergoing open-heart surgery or procedures requiring one-lung ventilation/ECMO/prolonged apnea/airway surgery, with prior bleomycin exposure, or recently enrolled are excluded and unlikely to directly benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, cluster-randomized, cluster-crossover trial assigns participating hospitals to one of three intraoperative FiO2 strategies (lower 0.21–0.40, intermediate 0.40–0.80, higher 0.80–1.00) for each study period. Adult patients intubated for surgery at those hospitals receive the assigned oxygen strategy during maintenance of anesthesia, and hospitals switch strategies by period. The primary outcome is a composite of postoperative organ injury (acute kidney injury, myocardial injury, lung injury, stroke) or death within 30 days, with secondary and exploratory outcomes including 30-day mortality, surgical site infection, length of stay, and hypoxemia. The trial is conducted under a waiver of informed consent because the interventions reflect routine intraoperative practice and individual consent is impracticable in the cluster-randomized design.

Why it matters

Potential benefit: If successful, the trial could identify an oxygenation approach that reduces postoperative organ injury and deaths after general anesthesia.

How similar studies have gone: Prior randomized and observational studies of higher intraoperative oxygen, particularly to prevent surgical site infection, have shown mixed or modest benefits and some signal for harm, so robust randomized data remain needed.

Who can join: the full rules

Show full inclusion / exclusion 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-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.

Where it's running

  • University of Michigan Hospital
    Ann Arbor, Michigan, United States     Recruiting
  • Nebraska Medical Center
    Omaha, Nebraska, United States     Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States     Recruiting
  • University of Utah Huntsman Cancer Institute
    Salt Lake City, Utah, United States     Recruiting

Study contacts

  • Principal investigator: Frederic T Billings, MD — Vanderbilt University Medical Center
  • Study coordinator: Tracie Baker, CCRA
  • Email: tracie.d.baker@vumc.org
  • Phone: 6158751852

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.