PeRiOperative Medicine Platform Trial
Domain-Specific Appendix: OXYGEN
Monash University
7,800 participants
Apr 6, 2026
INTERVENTIONAL
Conditions
Summary
Our specific aims are to investigate whether conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen during and immediately after surgery: Aim 1: Reduces surgical site infections (SSIs or "wound infections") and other healthcare-associated infections (pneumonia and sepsis). Aim 2: Reduces a pooled composite of serious postoperative complications, leading to a faster and more complete recovery after surgery, and thus increases "days alive and at home up to 30 days after surgery" (DAH30). Primary hypothesis: Liberal (80%) oxygen concentration delivered with anesthesia in patients undergoing major surgery reduces the incidence of SSIs after surgery compared to conservative (≤30%) or intermediate (50%) oxygen concentration. Secondary hypothesis: Hyperoxia (50-80%) delivered with anesthesia in patients undergoing major surgery increases the incidence of pulmonary and other complications after surgery compared to conservative (≤30%) oxygen concentration, resulting in fewer Days At Home (DAH). PROMPT enrolls patients undergoing elective or semi-elective surgery.
Eligibility
Inclusion Criteria2
- Adult patient (≥18 years of age at time of admission)
- Scheduled to undergo a surgical procedure involving a skin incision, with an expected duration of at least 2 hours, and a planned overnight hospital stay of at least 1 night (including, but not limited to, cardiac surgery, orthopedic surgery, obstetric, or gynecological surgery).
Exclusion Criteria10
- ASA physical status 5 (moribund, not expected to survive with or without an operation)
- Inability to provide informed consent
- Previous participation in PROMPT within the prior 30 days.
- ASA physical status 1 or 2
- Undergoing cardiac surgery
- Undergoing thoracic surgery if one-lung ventilation is required
- Currently suspected or proven infection
- Advanced lung disease requiring home oxygen therapy
- Previous bleomycin therapy
- Known or suspected pregnancy
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Interventions
The concentration of Oxygen will differ according to the randomisation
Conservative inspired oxygen
Intermediate inspired oxygen
Locations(2)
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NCT07186634