PeRiOperative Medicine Platform Trial

Not Applicable

Not yet recruiting

• Conditions: Anaesthesia; Major Complications; Quality of Life; Quality of Recovery (QoR-15); Surgical Site Infection After Major Surgery
• Interventions: Drug: Liberal inspired oxygen; Drug: Conservative inspired oxygen; Drug: Intermediate inspired oxygen

• Registration Number: NCT07186634
• Lead Sponsor: Monash University

Brief 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.

Detailed Description

www.promptssi.org.au

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-25
• Study Start: 2025-12-01
• Primary Completion: 2035-12
• Study Completion: 2035-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 7800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal inspired oxygen	Liberal inspired oxygen	FiO2 0.8; i.e. 80%
Conservative inspired oxygen	Conservative inspired oxygen	FiO2 ≤0.3 \[30%\]
Intermediate inspired oxygen	Intermediate inspired oxygen	FiO2 0.5 \[50%\]

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	30 days	A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision

Secondary Outcome Measures

Name	Time	Method
Quality of recovery	3 and 30 days after surgery	Quality of the individual's recovery post surgery - PROM. The scores of all 15 questions, with each item rated on a scale that results in a total score ranging from 0 (very poor recovery) to 150 (excellent recovery)
Mortality	30 days	All cause
EQ-5D-5L	30 days	Quality of life (EQ-5D-5L) at 30 days after index surgery. The resulting EQ-5D index score is a numerical value, with 1 representing full health, and scores less than 1 representing poorer health states, including negative values that indicate health states worse than death.
Health Care Associated Infections	30 days	pneumonia, blood stream infection and urinary tract infection
DAH 30	30 days	Days alive and at home at 30 days (DAH30) after index surgery (reflecting the patient's primary aim of a healthy recovery, reduced hospital costs and the impact/severity of serious complications, and avoiding re-admission (often due to SSI).
major postoperative complications	30 days	Description: A composite (and individually): Cardiovascular events (myocardial infarction, arterial or venous thrombosis, stroke, acute pulmonary edema, cardiogenic shock, new cardiac arrhythmia requiring treatment) Sepsis or septic shock (defined according to the Sepsis-3 definition)25 Respiratory complications - (i) pneumonia using US Centers for Disease Control criteria, (ii) Acute Respiratory Distress Syndrome using Berlin consensus definition, or (iii) the need for tracheal re-intubation and mechanical ventilation after extubation, and within 30 days after surgery OR mechanical ventilation for more than 24 h after surgery26 Unplanned intensive care unit (ICU) admission or readmission, defined as not anticipated preoperatively Acute kidney injury (based on the serum creatinine item of the Kidney Disease Improving Global Outcome criteria) Need for surgical re-intervention within 30 days after surgery Death within 30 days after surgery. Time Frame: 30 days

Trial Locations

Locations (1)

The Alfred; 🇦🇺 Melbourne, Victoria, Australia