Actively Recruiting
PeRiOperative Medicine Platform Trial
Led by Monash University · Updated on 2026-04-17
7800
Participants Needed
2
Research Sites
503 weeks
Total Duration
On this page
Sponsors
M
Monash University
Lead Sponsor
T
The Alfred
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PeRiOperative Medicine Platform Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (18 years of age or older at time of admission)
- Scheduled to undergo a surgical procedure involving a skin incision
- Expected surgery duration of at least 2 hours
- Planned overnight hospital stay of at least 1 night
- Surgery may include cardiac, orthopedic, obstetric, or gynecological procedures
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
2
Wellington Hospital
Wellington, NZ, New Zealand, 6012
Actively Recruiting
Research Team
P
Paul S Myles, DSc
CONTACT
T
Trisha Peel, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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