Anaesthesia, Major Complications, Quality of Life, Quality of Recovery (QoR-15), Surgical Site Infection After Major Surgery
Conditions
Keywords
Anaesthesiology, complications, oxygen, surgery, platform trial
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.
Detailed description
www.promptssi.org.au
Interventions
DRUGLiberal inspired oxygen
The concentration of Oxygen will differ according to the randomisation
DRUGConservative inspired oxygen
Conservative inspired oxygen
DRUGIntermediate inspired oxygen
Intermediate inspired oxygen
Sponsors
Monash University
The Alfred
Wellington Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
conservative (≤30%), intermediate (50%), or liberal (80%) inspired oxygen concentration
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | 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
| Measure | Time frame | Description |
|---|---|---|
| Health Care Associated Infections | 30 days | pneumonia, blood stream infection and urinary tract infection |
| Quality of recovery | 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) |
| major postoperative complications | 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 |
| Mortality | 30 days | All cause |
| EQ-5D-5L | 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. |
| DAH 30 | 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). |
Countries
Australia, New Zealand
Contacts
CONTACTPaul S Myles, DSc
CONTACTTrisha Peel, PhD
PRINCIPAL_INVESTIGATORPaul s Myles, DSc
Monash University
PRINCIPAL_INVESTIGATORTrisha Peel, PhD
Monash University
PRINCIPAL_INVESTIGATORDaniel Frei, PhD
Wellington Reginal Hospital
Outcome results
None listed