PeRiOperative Medicine Platform Trial (PROMPT)

Monash University

Status and phase: Not yet enrolling; Phase 4

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

Treatments: Drug: Intermediate inspired oxygen; Drug: Liberal inspired oxygen; Drug: Conservative inspired oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT07186634

2025-49324-130781

Details and patient eligibility

About

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.

Full description

www.promptssi.org.au

Enrollment: 7,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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7,800 participants in 3 patient groups

Liberal inspired oxygen

Active Comparator group

Description:

FiO2 0.8; i.e. 80%

Treatment:

Drug: Liberal inspired oxygen

Conservative inspired oxygen

Active Comparator group

Description:

FiO2 ≤0.3 \[30%\]

Treatment:

Drug: Conservative inspired oxygen

Intermediate inspired oxygen

Active Comparator group

Description:

FiO2 0.5 \[50%\]

Treatment:

Drug: Intermediate inspired oxygen