PROTECT- HFNO
Randomised feasibility comparison of High Flow Nasal Oxygen (HFNO) after major gut surgery
Patients undergoing major gut surgery have high-risk of postoperative pulmonary complications. Systematic review evidence suggests potential, but not definitive, benefit of High Flow Nasal Oxygen (HFNO) immediately after surgery. This project will assess the feasibility of a clinical trial of HFNO after major surgery, led by Dr Tom Abbott.
Aim: To undertake a randomised feasibility comparison of postoperative HFNO after major gut surgery using the PROTECT platform.
Design and setting: Open-label randomised platform clinical trial with masked outcome assessment in 200 patients from 10 NHS hospitals.
Population
Inclusion criteria:
- Patients aged 50 years and over undergoing elective major abdominal surgery, using open, laparoscopic or robotic surgical technique
Exclusion criteria:
- Inability or refusal to provide informed consent
- Anticipated requirement for invasive or non-invasive respiratory support for at least four hours
after surgery as part of routine clinical care - Clinician refusal
- Previous enrolment to the PROTECT-HFNO comparison
Intervention: High flow nasal oxygen started immediately after the end of surgery.
Comparator: Standard postoperative care, which may include conventional oxygen therapy.
Patient outcomes:
- Postoperative pulmonary complications within 30 days after surgery, a composite outcome comprising: pneumonia, Acute Respiratory Distress Syndrome, and/or Pulmonary Aspiration
- Re-intubation within 30 days after surgery
- DAH30
- All complications graded by Clavien-Dindo within 30 days of surgery
- Mortality within 30 days of surgery
- Duration of hospital stay (number of days from day of surgery until hospital discharge)
within 30 days after surgery - Compliance with HFNO, including duration delivered and any reasons for discontinuation
- Adverse events associated with HFNO
Hospital level outcomes:
- Number of eligible patients per year in each hospital
- Number of patients consented per year in each hospital
- Included hospital randomising at least one patient within the 12-month recruitment period
- Number of consultant surgeons and anaesthetists in each hospital who support recruitment of the patients in their care in principle as a proportion of those delivering care for elective major abdominal surgery
- Number of consultant surgeons and anaesthetists in each hospital who do not support recruitment of the patients in their care in principle as a proportion of those delivering care for elective major abdominal surgery