Domain-Specific Appendix: OXYGEN in Perioperative Medicine Platform Trial Evaluating Oxygen Concentrations During Major Surgery

What this Trial Is About

Researchers are evaluating different levels of oxygen concentration given during and immediately after major surgery to see how they affect surgical site infections and other healthcare-associated infections like pneumonia and sepsis. The study also looks at whether these oxygen levels impact serious postoperative complications and the speed and completeness of recovery, measured by days alive and at home within 30 days after surgery. The main focus is whether a higher oxygen concentration (80%) reduces wound infections compared to lower concentrations (30% or 50%). Participants will be randomly assigned to receive one of three oxygen levels during anesthesia: liberal (80%), intermediate (50%), or conservative (30%). These oxygen concentrations are delivered throughout the surgery and immediately afterward. The study involves adult patients undergoing elective or semi-elective surgeries expected to last at least 2 hours and requiring at least one overnight hospital stay. The trial is designed with triple masking to reduce bias. During the study, participants will be monitored for surgical site infections within 30 days after surgery, as well as other infections, recovery quality, major postoperative complications, mortality, and quality of life measures. Researchers will assess outcomes such as days alive and at home up to 30 days after surgery. The trial includes follow-up assessments at 3 and 30 days post-surgery to evaluate recovery and health status. Participation may last through the surgery and the 30-day post-surgery observation period.

PeRiOperative Medicine Platform Trial