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NCT Number: NCT07186634

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Alfred, Melbourne, Victoria, Australia

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About this study

www.promptssi.org.au

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liberal inspired oxygen

Drug

The concentration of Oxygen will differ according to the randomisation

Conservative inspired oxygen

Drug

Conservative inspired oxygen

Intermediate inspired oxygen

Drug

Intermediate inspired oxygen

Primary outcomes

  1. Surgical Site Infection

    Time frame: 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 outcomes

  1. Health Care Associated Infections

    Time frame: 30 days

    pneumonia, blood stream infection and urinary tract infection

  2. Quality of recovery

    Time frame: 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)

  3. major postoperative complications

    Time frame: 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

  4. Mortality

    Time frame: 30 days

    All cause

  5. EQ-5D-5L

    Time frame: 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.

  6. DAH 30

    Time frame: 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).

Other outcomes

  1. Cost Analysis

    Time frame: 30 days

    Direct health care costs at 30 days after index surgery Number of quality-adjusted life years (QALYs) at 30 days after index surgery Cost effectiveness measured as a cost per QALY.

Study contacts

Contact information is provided by the study sponsor or research team.

Paul S Myles, DSc

CONTACT

[email protected]

+6190762000 ext. 63176

Trisha Peel, PhD

CONTACT

[email protected]

+61 3 9076 5436

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • The Alfred
  • Wellington Hospital

Registry information

Official study title

Domain-Specific Appendix: OXYGEN

Acronym: PROMPT

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Sep 22, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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