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PeRiOperative Medicine Platform Trial

Study acronym: PROMPT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Dec 1, 2025 to Apr 6, 2026 · Study sites: 1 to 2 · Collaborators: 1 to 2v3 Show 3 more changesShow less
    • Start date changed from estimate of Dec 1, 2025 to Apr 6, 2026
    • Study sites: 1 to 2
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: Oxygen (Drug) to Conservative inspired oxygen (Drug), Intermediate inspired oxygen (Drug), Liberal inspired oxygen (Drug) Eligibility criteria shortened, about 69 words · Secondary endpoints revised (6)v2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 69 words
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07186634
Lead Sponsor Monash University
Collaborators: The Alfred, Wellington Hospital
Conditions Surgical Site Infection After Major Surgery, Anaesthesia, Major Complications, Quality of Recovery (QoR-15), Quality of Life
Enrollment 7,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov