Impact of Intraoperative Oxygenation Practices on Patient Outcomes
Purpose
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.
Condition
- Surgeries Undergoing General Anesthesia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- Cluster randomized, cluster crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Outcomes are measured through routine clinical care. The primary statistician is masked to treatment assignments during analysis.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lower FiO2 |
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Experimental Intermediate FiO2 |
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Experimental Higher FiO2 |
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Recruiting Locations
Nashville 4644585, Tennessee 4662168 37212
More Details
- Status
- Recruiting
- Sponsor
- Frederic T Billings IV
Detailed Description
The Intraop Ox trial will enroll adult patients undergoing surgery with tracheal intubation. Participating hospitals will be randomly assigned (as a unit) to administer one of three oxygenation strategies during maintenance anesthesia (lower FiO₂ [0.21-0.40], intermediate FiO₂ [0.40-0.80], or higher [FiO₂ 0.80-1.00] each period (month). The primary outcome is a composite of organ injury (acute kidney injury, myocardial injury, lung injury, stroke) or death within 30 days. Secondary outcome is 30-day mortality. Exploratory outcomes are individual components of the composite primary endpoint, surgical site infection, length of stay, and hypoxemia. The study is conducted under a waiver of informed consent due to minimal incremental risk of participating and impracticability of obtaining consent in this cluster-randomized design.