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PeRiOperative Medicine Platform Trial

RecruitingPhase 4Ages 18 Years - anyAllMonash University
NCT07186634 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 c

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📋 Eligibility rules (as published)
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
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What it tests

  • Liberal inspired oxygen
  • Conservative inspired oxygen
  • Intermediate inspired oxygen
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Where

2 sites
The Alfred
Melbourne, Australia
Wellington Hospital
Wellington, New Zealand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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