Domiciliary NHF and patient outcomes in CHRF in the UK

  • Research type

    Research Study

  • Full title

    Does domiciliary Nasal High Flow (NHF) therapy improve patient outcomes in Chronic Hypercapnic Respiratory Failure (CHRF) in the UK?: A pre and post interventional study

  • IRAS ID

    307348

  • Contact name

    Swapna Mandal

  • Contact email

    swapnamandal@nhs.net

  • Sponsor organisation

    Royal Free London NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05167201

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary


    Research Summary:

    Patients with chronic obstructive pulmonary disease (COPD) or OHS (obesity hypoventilation syndrome) can often have disabling breathlessness that limits their day to day activities. They are also at increased risk of hospital visits when they are unwell due to low oxygen levels and high toxic gases such as carbon dioxide in their blood. All of this combined together can reduce their overall quality of life. Studies have shown that a treatment called Non-Invasive Ventilation (NIV) can improve the outcomes for patients suffering with chronic lung disease as a result of either COPD or obesity hypoventilation.

    NIV currently involves breathing through a tight fitting mask connected to a machine. This equipment acts as a home ventilator for patients but can be uncomfortable to use and means that patients struggle to use it on a daily basis. This may affect the health benefits that patients would gain if they cannot use it for the recommended time needed. Some patients may not use this treatment at all, as it is so uncomfortable for them and there are no currently no available other treatments similar to this.

    We therefore wish to explore how acceptable and practical it is to use an alternative therapy called Nasal High Flow therapy (NHF) in this group of patients unable to use a home ventilator. NHF is a nasal cannula which sits just under the nostrils instead and delivers warmed, humidified, high air flow and may offer increased comfort to these patients.

    We wish to explore patients experience with NHF, to examine the effects it has on the breathing system and whether it improves breathlessness, quality of life and reduces healthcare visits. This may allow us to better predict and advise patients on treatment options in the future and we hope this information can be used to improve patient care.

    Research Findings:

    People with chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) can develop high levels of carbon dioxide in their blood because they do not breathe effectively, particularly during sleep. Many people are treated with a home breathing machine called domiciliary non-invasive ventilation (D-NIV). However, some people find this treatment uncomfortable and struggle to use it regularly.
    This study looked at whether home high-flow nasal therapy (HFNT); a different therapy to D-NIV, which delivers warm, humidified air through soft nasal tubes, could help people with COPD or OHS who could not tolerate D-NIV.
    Forty-six people participated in the study, and 27 completed 12 weeks of HFNT treatment at home. Participants used the therapy on just over half of all nights (for 56% of nights overall, with a usage of more than four hours for 32% of nights). Only a small number (3 individuals) stopped because they could not tolerate the device.
    After 12 weeks, participants reported a better quality of life (demonstrated by an improvement in the severe respiratory insufficiency index (SRI), mean difference = 13.7, p<0.001), felt less breathless (demonstrated by a reduction in the Borg index, mean difference = -1.37 (1.59), p<0.001), and they were able to walk further during an exercise test (demonstrated by an improvement in the six-minute walk test by an average of 42.1 metres, p<0.01). Their overnight carbon dioxide levels also improved (demonstrated by a reduction of 0.41 kPa, p=0.01), suggesting that their breathing was more effective while they slept.
    These findings suggest that home HFNT could be a useful alternative for people with COPD or OHS who are unable to use D-NIV. More research is needed to identify which patients are most likely to benefit and to determine how HFNT can be used safely in people with more severe breathing problems.

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    21/LO/0888

  • Date of REC Opinion

    11 Jan 2022

  • REC opinion

    Further Information Favourable Opinion