Clinical Trial

PeRiOperative Medicine Platform Trial

Study acronym: PROMPT
Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-15; most recent amendment 2026-04-14.
Status change: Not Yet Recruiting → Recruiting 2026-04-14
Trial Details
NCT Number NCT07186634
Lead Sponsor Monash University
Collaborators: The Alfred, Wellington Hospital
Conditions Surgical Site Infection After Major Surgery, Anaesthesia, Major Complications, Quality of Recovery (QoR-15), Quality of Life
Enrollment 7,800 participants
Start Date 2026-04-06
Primary Completion 2035-12 (estimated)
Study Completion 2035-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-17