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.
Study details:
www. promptssi. org.
au.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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).
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.
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE4
Study ID
NCT07186634
Intervention or treatment
DRUG: Liberal inspired oxygen
DRUG: Conservative inspired oxygen
DRUG: Intermediate inspired oxygen
Conditions
- Surgical Site Infection After Major Surgery
- Anaesthesia
- Major Complications
- Quality of Recovery (QoR-15)
- Quality of Life
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Research sites nearby
Closest Location:
The Alfred
Select from list below to view details:
The Alfred
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Monash University
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Liberal inspired oxygen
| Drug: Liberal inspired oxygen |
ACTIVE_COMPARATOR: Conservative inspired oxygen
| Drug: Conservative inspired oxygen |
ACTIVE_COMPARATOR: Intermediate inspired oxygen
| Drug: Intermediate inspired oxygen |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Health Care Associated Infections | pneumonia, blood stream infection and urinary tract infection | 30 days |
| Quality of recovery | 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 and 30 days after surgery |
| major postoperative complications | 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 | 30 days |
| Mortality | All cause | 30 days |
| EQ-5D-5L | 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. | 30 days |
| DAH 30 | 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). | 30 days |
References
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