PeRiOperative Medicine Platform Trial

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.

Conditions

• Surgical Site Infection After Major Surgery
• Anaesthesia
• Major Complications
• Quality of Recovery (QoR-15)
• Quality of Life

Interventions

DRUG

Liberal inspired oxygen

The concentration of Oxygen will differ according to the randomisation

DRUG

Conservative inspired oxygen

Conservative inspired oxygen

DRUG

Intermediate inspired oxygen

Intermediate inspired oxygen

Sponsors & Collaborators

• The Alfred

  collaborator OTHER

• Wellington Hospital

  collaborator OTHER_GOV

• Monash University

  lead OTHER

Principal Investigators

• Paul s Myles, DSc · Monash University

• Trisha Peel, PhD · Monash University

• Daniel Frei, PhD · Wellington Reginal Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-06

Primary Completion

2035-12-31

Completion

2035-12-31

FDA Drug

Yes

Countries

• Australia
• New Zealand

Study Locations