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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Miss Ellen Temple
+44 (0)1223 638000
ellen.temple4@nhs.net


Prof Andrew Klein
+44 (0)1223 639 349
andrew.klein@nhs.net


Dr Melissa Duckworth
+44 (0)1223 639 667
Melissa.Duckworth@nhs.net


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Be Part of Research - Trial Details - Nasal high-flow oxygen therapy after cardiac surgery
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Nasal high-flow oxygen therapy after cardiac surgery

Not Recruiting

Open to: All Genders

Age: Adult

London Middlesbrough Birmingham Papworth Everard Leicester London London Clydebank Cardiff Murdoch Subiaco Douglas Chermside Sydney Auckland Melbourne Geelong

Medical Conditions

Postoperative pulmonary complications after cardiac surgery

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Patients with pre-existing lung conditions undergoing heart surgery are at higher risk of complications after surgery such as chest infection or pneumonia. They may need a tight-fitting mask to help them breathe and ensure that enough oxygen gets into their blood and carbon dioxide is removed. This treatment is costly, labour intensive and can be uncomfortable. Treatment for lung complications can lead to a prolonged hospital stay or even death. Recently, there has been increased interest in the use of high-flow nasal therapy (HFNT) after cardiac surgery. High-flow nasal therapy (HFNT) provides warmed humidified oxygen (air that is warmed and contains some moisture) and has been shown to assist breathing and improve patient recovery. HFNT is comfortable during use and may be even more comfortable than standard treatment with dry oxygen via a face mask or nasal prongs. Without a tight-fitting mask, patients can eat normally and speak freely. In light of this, a study recently investigated whether high-risk patients with certain lung conditions (asthma, chronic obstructive pulmonary disease) or a risk factor for postoperative lung complications (obesity, recent chest infections or heavy smoking), would benefit from routine administration of high-flow nasal therapy immediately after cardiac surgery. The study showed that when compared with standard care, the use of HFNT significantly reduced hospital length of stay (by 29%) and was associated with fewer re-admissions to the intensive care unit. This was the first randomised trial to examine the effect of high-flow nasal therapy compared to standard dry oxygen via nasal prong, on patient-relevant outcomes (length of hospital stay), after open-heart surgery in patients at high risk of postoperative lung complications. The researchers presented the study results to patients who participated in this first trial and both clinicians and participants agreed that it is extremely important to test whether the results can be replicated in a large multicentre study. This study will expand the first trial into nine other UK hospitals (ten hospitals in total including Royal Papworth Hospital), seven Australian hospitals and one hospital in New Zealand, in order to see if the positive findings can be repeated and whether HFNT should become routine in this patient group after cardiac surgery.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

07 Oct 2020 19 Jun 2024

Publications

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35987698/ (added 22/08/2022)2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35346339/ (added 13/07/2023)2025 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39874369/ Economic evaluation protocol and analysis plan (added 31/01/2025)

To assess the effect of HFNT the researchers will be recruiting a minimum of 1280 participants from ten UK hospitals, seven Australian hospitals and one hospital in New Zealand, and randomly allocating them to receive high-flow nasal therapy or standard oxygen therapy. Before their surgery, participants will be asked to complete two quality-of-life questionnaires and a questionnaire collecting information about where they live, health service use 1 month before surgery and current medications. On the day of surgery, the surgical procedure will go ahead as usual and it will be during surgery that allocation to treatment is done. As participants are woken from surgery, the intensive care nurses and doctors will give the allocated therapy for a minimum of 16 hours after surgery (with a total of 1 hour off treatment allowed for any required transfers around the hospital and/or physio mobilisation). Upon discharge from hospital, participants will be asked to maintain a location and medication diary and to complete the same questionnaires as before surgery, on three further occasions. Participants will be followed up by the Royal Papworth Hospital research team at 30 and 90 days after surgery.


Patients aged 18 or over who are scheduled to undergo open-heart surgery conducted on cardiopulmonary bypass and have one or more risk factors (e.g. chronic lung disease [COPD], asthma, current or recent smoker, recent chest infection, obesity) for developing breathing complications after the operation.

You can take part if:


Current inclusion criteria as of 19/10/2023:
1. Aged 18 years or over
2. Undergoing any elective or urgent first-time or redo cardiac surgery performed on cardiopulmonary bypass
3. Have one or more clinical patient-related risk factor for postoperative pulmonary complications (COPD, asthma, lower respiratory tract infection in last 4 weeks as defined by use of antibiotics, body mass index >=35 kg/m², current (within the last 6 weeks) heavy smokers (>10 pack


You may not be able to take part if:


1. Requiring home oxygen therapy2. Deep hypothermic circulatory arrest planned3. Contraindication to HFNT, e.g. nasal septal defect4. Requirement for home respiratory support (including: CPAP, BiPAP)5. Requiring emergency cardiac surgery defined as surgery required within 24 hours of the decision to operate6. Patients not fluent in English


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • King's College Hospital NHS Foundation Trust
    Denmark Hill
    London
    SE5 9RS
  • South Tees Hospitals NHS Foundation Trust
    James Cook University Hospital Marton Road
    Middlesbrough
    TS4 3BW
  • University Hospitals Birmingham NHS Foundation Trust
    Queen Elizabeth Hospital Mindelsohn Way Edgbaston
    Birmingham
    B15 2GW
  • Royal Papworth Hospital NHS Foundation Trust
    Papworth Everard
    Cambridge
    CB23 3RE
  • University Hospitals of Leicester NHS Trust
    Leicester General Hospital Gwendolen Road
    Leicester
    LE5 4PW
  • Guy's and St Thomas' NHS Foundation Trust
    4th Floor, Gassiot House St Thomas's Hospital Westminster Bridge Road
    London
    SE1 7EH
  • Guy's and St Thomas' NHS Foundation Trust
    Royal Brompton Hospital Sydney Street
    London
    SW3 6NP
  • NHS National Waiting Times Centre Board
    Golden Jubilee National Hospital Agamemnon Street
    Clydebank
    G81 4DY
  • Cardiff & Vale University Local Health Board
    University Hospital of Wales Health Park
    Cardiff
    CF14 4XW
  • Fiona Stanley Hospital
    11 Robin Warren Drive
    Murdoch
    WA 6150
  • St John of God Hospital
    12 Salvado Road
    Subiaco
    WA 6008
  • The Townsville University Hospital
    100 Angus Smith Drive
    Douglas
    QLD 4814
  • The Prince Charles Hospital
    Rode Rd
    Chermside
    QLD 4032
  • Royal North Shore Hospital
    Reserve Road St Leonards
    Sydney
    NSW 2065
  • Auckland City Hospital
    Park Road Grafton
    Auckland
    1023
  • The Alfred Hospital
    55 Commercial Rd
    Melbourne
    VIC 3004
  • The University Hospital Geelong, Barwon Health
    Bellerine Street
    Geelong
    VIC 3220

High-flow nasal therapy is an established therapy which is proven to be safe and effective in a variety of clinical settings. If, after surgery, participants require more support with their breathing, the clinical team will always have the ability to give what they feel is most beneficial. High-flow nasal therapy does generate some low-level noise and participants may feel hot whilst wearing the device due to the warmed humidified oxygen. If a participant starts to feel too hot, a nurse or doctor can decrease the temperature of the oxygen slightly or provide a fan to cool them down. There are no direct personal benefits for participating in the study; however, participants could help a future generation of patients make better-informed choices about their treatment. For participants allocated to high-flow nasal therapy, they may experience benefits in terms of making breathing easier, reducing the chances of their lungs getting blocked by secretions and reducing the chances of picking up a chest infection (e.g., pneumonia). This may mean participants feel better quicker after surgery.

Dr Melissa Duckworth
+44 (0)1223 639 667
Melissa.Duckworth@nhs.net


Prof Andrew Klein
+44 (0)1223 639 349
andrew.klein@nhs.net


Miss Ellen Temple
+44 (0)1223 638000
ellen.temple4@nhs.net



The study is sponsored by Royal Papworth Hospital NHS Foundation Trust; Curtin School of Population Health and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR128351; Green Lane Research and Educational Fund; Medical Research Future Fund International Clinical Trial Collaboration (MRFF ICTC) (Australia).



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Read full details for Trial ID: ISRCTN14092678

Or CPMS 45298

Last updated 31 January 2025

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