PeRiOperative Medicine Platform Trial

NCT07186634 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2025-49324-130781
• Study Type: interventional
• Target: 7,800
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

Anaesthesiology, complications, oxygen, surgery; platform trial

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  A post operative infection that develops at the site of an operation, caused by bacteria entering the body through the surgical incision

  30 days

Secondary Outcomes (6)

• Health Care Associated Infections

  30 days

• Quality of recovery

  3 and 30 days after surgery

• major postoperative complications

  30 days

• Mortality

  30 days

• EQ-5D-5L

  30 days

Other Outcomes (1)

• Cost Analysis

  30 days

Study Arms (3)

Liberal inspired oxygen

ACTIVE COMPARATOR

FiO2 0.8; i.e. 80%

Drug: Liberal inspired oxygen

Conservative inspired oxygen

ACTIVE COMPARATOR

FiO2 ≤0.3 \[30%\]

Drug: Conservative inspired oxygen

Intermediate inspired oxygen

ACTIVE COMPARATOR

FiO2 0.5 \[50%\]

Drug: Intermediate inspired oxygen

Interventions

Liberal inspired oxygen DRUG

The concentration of Oxygen will differ according to the randomisation

Liberal inspired oxygen

Conservative inspired oxygen DRUG

Conservative inspired oxygen

Conservative inspired oxygen

Intermediate inspired oxygen DRUG

Intermediate inspired oxygen

Intermediate inspired oxygen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Monash University: lead
• The Alfred: collaborator
• Wellington Hospital: collaborator

Study Sites (2)

The Alfred

Melbourne, Victoria, 3004, Australia

RECRUITING

Wellington Hospital

Wellington, NZ, 6012, New Zealand

RECRUITING

Study Officials

• Paul s Myles, DSc

  Monash University

  PRINCIPAL INVESTIGATOR

• Trisha Peel, PhD

  Monash University

  PRINCIPAL INVESTIGATOR

• Daniel Frei, PhD

  Wellington Reginal Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul S Myles, DSc

CONTACT

+6190762000; p.myles@alfred.org.au

Trisha Peel, PhD

CONTACT

+61 3 9076 5436; trisha.peel@monash.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen concentration

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: April 6, 2026
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NZ (1)