Impact of Intraoperative Oxygenation Practices on Patient Outcomes (NCT07224243) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Intraoperative Oxygenation Practices on Patient Outcomes
United States54,000 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether the amount of oxygen given during surgery under general anesthesia affects the risk of organ injury or death within 30 days — how might the oxygen level used during my specific procedure affect my personal risk of complications?
2Since this is listed as Phase NA, meaning it may be observational or a pragmatic study rather than a traditional drug trial, can you explain whether participating would actually change how my surgery is managed, or whether my care would proceed as it normally would?
3The trial is measuring a composite outcome that includes organ injury and in-hospital death within 30 days — what organs are most at risk during the type of surgery I'm having, and how does current oxygen practice during my procedure compare to what this trial is investigating?
4Are there specific types of patients or surgeries where the oxygen approach being studied in this trial might carry more benefit or more risk, and does my health situation put me in one of those groups?
5If I choose not to participate in this trial, would my surgical team still follow evidence-based oxygen practices during my operation, or is standard care at this point still genuinely uncertain in a way that makes joining this study worth discussing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of organ injury or in-hospital death within 30 days of surgery