Perioperative oxygen comparison for adults having major surgery
Official title: Domain-Specific Appendix: OXYGEN
Run by Monash University · NCT07186634 · Data updated 2026-11-12
This will test whether giving higher (80%), medium (50%), or lower (≤30%) oxygen during and right after major surgery changes wound infection rates and recovery for adults having longer operations.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 7800 (estimated) |
| Sponsor | Monash University Academic / other |
| Locations | 2 sites (Melbourne, Victoria and 1 other locations) |
| Status | Recruiting |
| Started | April 6, 2026 |
| Main results expected | December 2035 |
| Study ends | December 2035 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07186634 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) scheduled for a surgical procedure with a skin incision lasting at least two hours and a planned overnight hospital stay who can give consent and do not meet exclusion criteria such as ASA 5, active infection, advanced home oxygen–dependent lung disease, recent bleomycin therapy, pregnancy, or certain cardiac/thoracic procedures.
✕Probably not a fit
People having short or day-case operations, those unable to consent, those with active infection or severe lung disease, or patients undergoing excluded procedures (for example some cardiac or one-lung ventilation thoracic surgeries) are unlikely to be eligible or to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults undergoing major surgery with a skin incision and an expected duration of at least two hours are assigned to receive one of three inspired oxygen levels during and immediately after their operation: conservative (≤30%), intermediate (50%), or liberal (80%). The trial tracks surgical site infections as the primary outcome and a pooled composite of serious postoperative complications, pulmonary events, and 'days alive and at home up to 30 days after surgery' (DAH30) as secondary outcomes. The platform design allows multiple oxygen strategies to be compared concurrently across participating hospitals. Safety monitoring focuses on pulmonary complications and other harms potentially related to higher oxygen concentrations.
Why it matters
Potential benefit: If successful, the right oxygen approach could reduce wound infections and speed a safer, more complete recovery after major surgery.
How similar studies have gone: Previous trials of higher inspired oxygen to prevent surgical wound infections have produced mixed results, with some early benefits reported but ongoing controversy and concern about possible pulmonary harms.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
The Alfred
Melbourne, Victoria, Australia Recruiting -
Wellington Hospital
Wellington, Nz, New Zealand Recruiting
Study contacts
- Principal investigator: Paul s Myles, DSc — Monash University
- Study coordinator: Paul S Myles, DSc
- Email: p.myles@alfred.org.au
- Phone: +6190762000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.