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Perioperative Platform Trial (PROTECT)
  1. Perioperative Platform Trial (PROTECT)
  2. Studies
  3. PROTECT-HFNO

PROTECT-HFNO

A 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.

PROTECT-HFNO Appendix v3.0 19.06.2025.pdf [PDF 814KB]

 

https://doi.org/10.1186/ISRCTN17843119

Open-label randomised platform clinical trial with masked outcome assessment in 200 patients from 10 NHS hospitals.

  1. Patients aged 50 years and over undergoing elective major abdominal surgery, using open, laparoscopic or robotic surgical technique

 

  1. Inability or refusal to provide informed consent
  2. Anticipated requirement for invasive or non-invasive respiratory support for at least four hours
    after surgery as part of routine clinical care
  3. Clinician refusal
  4. Previous enrolment to the PROTECT-HFNO comparison

High flow nasal oxygen started immediately after the end of surgery.

Diagram showing a HFNO nasal cannula device

 

Standard postoperative care, which may include conventional oxygen therapy.

  1. Postoperative pulmonary complications within 30 days after surgery, a composite outcome comprising: pneumonia, Acute Respiratory Distress Syndrome, and/or Pulmonary Aspiration
  2. Re-intubation within 30 days after surgery
  3. DAH30
  4. All complications graded by Clavien-Dindo within 30 days of surgery
  5. Mortality within 30 days of surgery
  6. Duration of hospital stay (number of days from day of surgery until hospital discharge)
    within 30 days after surgery
  7. Compliance with HFNO, including duration delivered and any reasons for discontinuation
  8. Adverse events associated with HFNO
  1. Number of eligible patients per year in each hospital
  2. Number of patients consented per year in each hospital
  3. Included hospital randomising at least one patient within the 12-month recruitment period
  4. 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
  5. 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

Information for patients

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