Oxygen treatment using high flow nasal oxygen after major abdominal surgery
| ISRCTN | ISRCTN17843119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17843119 |
| Integrated Research Application System (IRAS) | 350757 |
| Central Portfolio Management System (CPMS) | 65317 |
| Grant Code | WKR0-2023-0016 |
| Sponsor | Queen Mary University of London |
| Funders | Barts Charity, British Journal of Anaesthesia |
- Submission date
- 26/11/2025
- Registration date
- 03/12/2025
- Last edited
- 03/12/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
We are studying better ways to look after patients who have surgery. We hope these new techniques will help patients recover more quickly after surgery, so they can return home sooner, and in better health. One approach that may help is to use a device, which assists a patient's breathing immediately after abdominal surgery. We think this may help patients recover better and avoid complications such as chest infection, which can occur in a small number of patients. If we can show that patients and doctors are comfortable taking part in this small trial, we will then perform a much larger clinical trial that will tell us which patients may benefit from the treatment.
Who can participate?
Patients aged 50 years and over, undergoing major abdominal surgery
What does the study involve?
The patient's operation will proceed as planned, and almost all treatment will not change. As they wake up after surgery, they will be either offered extra oxygen through a loose facemask, which is standard treatment, or given treatment to help them breathe more easily. This is called High Flow Nasal Oxygen, or HFNO for short. HFNO provides extra oxygen and is delivered through a nasal cannula device that sites just under the nose. If offered HFNO, this will be for the first four hours after waking up from the operation. If allocated to receive usual treatment of the standard facemask oxygen, no medical care will change. Medical notes will be review until discharge from hospital, up to 30 days.
What are the possible benefits and risks of participating?
Breathing after surgery may be temporarily better if taking part in the study and receive HFNO, but this isn't known for certain. The treatment is very safe and has been used in hospital for many years. All patients will be carefully monitored throughout to ensure any problems are detected and treated promptly. By collecting this information about HFNO and recovery, we hope to work out if HFNO is helpful for patients recovering from surgery and it may help improve care of patients in the future.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
The study will start in December 2025 and run for 12 months.
Who is funding the study?
Barts Charity and the British Journal of Anaesthesia.
Who is the main contact?
Dr Tom Abbott, protect-admin@qmul.ac.uk
Contact information
Scientific, Principal investigator
Royal London Hospital
London
E1 1FR
United Kingdom
| Phone | +44 (0)203 594 0349 |
|---|---|
| Protect-admin@qmul.ac.uk |
Public
Royal London Hospital
London
E1 1FR
United Kingdom
| Phone | +44 (0)203 594 0349 |
|---|---|
| Protect-admin@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | High flow nasal oxygen for patients undergoing elective major abdominal surgery |
| Study acronym | PROTECT-HFNO |
| Study objectives | 1. To demonstrate willingness of patients to participate in the trial 2. To demonstrate whether relevant healthcare staff within participating hospitals are willing to randomise patients into the trial 3. To provide feasibility data on the clinical effects of HFNO, in reducing postoperative pulmonary complications and days alive and at home (DAH30) after elective major abdominal surgery, compared to standard care 4. To provide safety data on the use of High Flow Nasal Oxygen (HFNO) in patients undergoing elective major abdominal surgery |
| Ethics approval(s) |
Approved 10/02/2025, London – South East Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8222; londonsoutheast.rec@hra.nhs.uk), ref: 24/LO/0888 |
| Health condition(s) or problem(s) studied | Adult patients undergoing elective major abdominal surgery |
| Intervention | The master protocol for this study is registered at https://www.isrctn.com/ISRCTN14639555 Eligible patients will be approached for consent before surgery. If consented their baseline and demographic information will be collected for study purposes. There are two groups a patient will be randomly allocated to after surgery, usual care or High Flow Nasal Oxygen (HFNO) administered for 4 hours post surgery, other information pertaining to the surgical procedure and follow up information at 30 days will also be collected to answer the research question. |
| Intervention type | Other |
| Primary outcome measure(s) |
Patient outcome measures: |
| Key secondary outcome measure(s) |
There are no secondary outcome measures as this is a feasibility study |
| Completion date | 01/02/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Patients aged 50 years and over undergoing elective major abdominal surgery, using open, laparoscopic or robotic surgical technique |
| Key exclusion criteria | 1. Inability or refusal to provide informed consent 2. Anticipated requirement for invasive or non-invasive respiratory support for at least 4 hours after surgery as part of routine clinical care 3. Previous enrolment in the PROTECT-HFNO comparison 4. Clinician refusal |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/12/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
80 Newark Street
London
E1 2ES
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | Consent form | 19/06/2025 | 01/12/2025 | No | No |
| Protocol file | version 3.0 | 19/06/2025 | 01/12/2025 | No | No |
Additional files
Editorial Notes
26/11/2025: Study's existence confirmed by the NIHR.
