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Clinical Trials in Australia / NCT07186634
Recruiting Phase 4

PeRiOperative Medicine Platform Trial

NCT07186634 · tracked via the Priya Life Science Australia tracker
Sponsor
Monash University
Phase
Phase 4
Started
2026-04-06
Last updated
2026-04-17

Condition(s) studied

Surgical Site Infection After Major SurgeryAnaesthesiaMajor ComplicationsQuality of Recovery (QoR-15)Quality of Life

Investigational drug(s) / intervention(s)

Liberal inspired oxygenConservative inspired oxygenIntermediate inspired oxygen

Liberal inspired oxygen: The concentration of Oxygen will differ according to the randomisation

Conservative inspired oxygen: Conservative inspired oxygen

Intermediate inspired oxygen: Intermediate inspired oxygen

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
PROMPT - Inclusion Criteria: * 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). PROMPT - Exclusion Criteria: * 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. DSA 02 - PROMPT - Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
The Alfred Melbourne Victoria Recruiting
Wellington Hospital Wellington NZ Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07186634 on ClinicalTrials.gov ↗ ← All trials in Australia