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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Conservative inspired oxygen, a drug called Intermediate inspired oxygen, and others for people with anaesthesia, major complications, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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