Intraoperative oxygen levels and postoperative outcomes in adults

Impact of Intraoperative Oxygenation Practices on Patient Outcomes

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

• Phase: NA
• Study type: Interventional
• Enrollment: 54000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vanderbilt University Medical Center (other)
• Locations: 4 sites (Ann Arbor, Michigan and 3 other locations)
• Trial ID: NCT07224243 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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 performed: 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.

Eligibility 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 this trial is running

Ann Arbor, Michigan and 3 other locations

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

Study contacts

• Principal investigator: Frederic T Billings, MD — Vanderbilt University Medical Center
• Study coordinator: Tracie Baker, CCRA

Conditions: Surgeries Undergoing General Anesthesia, Intraoperative oxygenation, oxygen, surgery, anesthesia, mechanical ventilation, organ injury, acute kidney injury