PeRiOperative Medicine Platform Trial

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.

www.promptssi.org.au

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