RecruitingPhase 4NCT07186634

PeRiOperative Medicine Platform Trial

Domain-Specific Appendix: OXYGEN


Sponsor

Monash University

Enrollment

7,800 participants

Start Date

Apr 6, 2026

Study Type

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

Min Age: 18 Years

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

DRUGLiberal inspired oxygen

The concentration of Oxygen will differ according to the randomisation

DRUGConservative inspired oxygen

Conservative inspired oxygen

DRUGIntermediate inspired oxygen

Intermediate inspired oxygen


Locations(2)

The Alfred

Melbourne, Victoria, Australia

Wellington Hospital

Wellington, NZ, New Zealand

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NCT07186634


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