HiFlo ASA
Research type
Research Study
Full title
High Flow humidified oxygen as an early intervention in children with Acute Severe Asthma. A feasibility study (HiFlo ASA).
IRAS ID
261627
Contact name
Paul Seddon
Contact email
Sponsor organisation
Brighton & Sussex University Hospitals NHS Trust
Duration of Study in the UK
1 years, 11 months, 25 days
Research summary
Asthma affects 1 in 11 British children. Attacks of Acute Severe Asthma (ASA) are among the commonest reasons for children to attend hospital emergency departments. Many children do not respond to initial treatment, and need to stay in hospital for rescue therapy. Current rescue therapy is unsatisfactory and has unpleasant side effects.
High flow humidified oxygen (HiFlo) is a new treatment which helps children breathe by delivering moist air enriched with oxygen down into the airways of the lungs, through short soft tubes that fit snugly into the nostrils. It is more comfortable than other methods of breathing support and has a good safety record. HiFlo is already being used in:
• premature babies with breathing problems
• babies with virus lung infections
• ASA, later on when rescue therapy has failed
We believe that starting HiFlo early on in ASA will speed up recovery and reduce the need for unpleasant rescue therapy. Before starting a large national trial to decide whether early HiFlo is effective, we need to run a feasibility study (a small test version of the full trial). We have designed this together with children and parents. 70 children (2–11 years) with ASA will be randomised in the emergency department to standard care or early Hi-Flo.
We will compare, between the two groups:
• how quickly they improve and are ready to go home
• how many have side effects
• how many end up needing rescue treatment
• what children, parents and staff think about being involved in the researchThings need to move quickly during emergency treatment, and children and parents are often very distressed. Because of this we will delay asking for consent for the research until the emergency has passed, but we will let families know the research is taking place.
Summary of results
Asthma affects 1 in 11 British children, and acute severe asthma attacks (ASA) are among the commonest reasons for children to attend hospital. Many children do not respond to initial treatment and need rescue therapy. Current rescue therapy is unsatisfactory and has unpleasant side effects.High flow humidified oxygen (HiFlo) is a new treatment which helps children breathe by delivering lots of moist air enriched with oxygen. It is already used in the NHS for other breathing difficulties, but we do not know if it is effective in children with ASA.
Before starting a large national trial to decide whether early HiFlo is effective, we ran a feasibility study (a small test version of the full trial), to decide whether a full trial would be workable. It was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB) Programme. It was sponsored by University Hospitals Sussex, and was carried out in hospitals across England. In designing and running the trial, we worked closely with the Kent Surrey and Sussex Young People’s Advisory Group and a panel of parents of children with asthma.
We studied children aged 2 to 11 years with ASA who had not responded to initial treatment in hospital. We allocated them randomly (by chance) to receive either early HiFlo or standard treatment. We approached families for consent once their child was no longer seriously ill.
The study was conducted between February 2020 and June 2023. Despite disruption by the COVID-19 pandemic, we enrolled 56 children in 4 hospitals in England, and received consent for 50 children (89%). We were able to collect the essential data about treatment effectiveness in all children. Feedback from families on the experience of being in the trial was very positive.
64% of children allocated HiFlo, and 86% of children allocated standard care required further rescue treatment. On average, children allocated HiFlo were ready for discharge from hospital after 29 hours, compared to 37 hours for the standard care group, but the time to being ready for discharge was very variable and there was considerable overlap between the groups.
Our results show that a full trial of early HiFlo in ASA is feasible., We have used the data from this study to plan the size and design of the trial, and have applied for further funding from the NIHR to carry out the full trial.
Our findings have been presented at the European Respiratory Society Annual Conference September 2023, South Thames Paediatric Network Severe Asthma Webinar May 2024 and to the Kent Surrey and Sussex Young People’s Advisory Group and associated parents and carers group January 2024. The protocol was published in JMIR Research Protocols: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.researchprotocols.org%252F2024%252F1%252Fe54081%252F.%2FNBTI%2FeyW6AQ%2FAQ%2F59e4fd49-ca84-477d-a8f9-43a7b034c442%2F2%2FeNzjppQBIO&data=05%7C02%7Csolihull.rec%40hra.nhs.uk%7Caee0bcb15a094bfd01dc08dd20fcc128%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638702992116738525%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=LjO8iN2r7AT5g9nmmETOpllUdbqk%2FNZUylGW9N10Gzk%3D&reserved=0 Results were published in the ERJ Open Research https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1183%252F23120541.00168-2024.%2FNBTI%2FeyW6AQ%2FAQ%2F59e4fd49-ca84-477d-a8f9-43a7b034c442%2F3%2FQVeMTEvCAe&data=05%7C02%7Csolihull.rec%40hra.nhs.uk%7Caee0bcb15a094bfd01dc08dd20fcc128%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638702992116751837%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=E6B6vj1zmNJ%2FurVsYNvjBQTn77TLPCzgjJ7ijM5oyiU%3D&reserved=0
This lay results summary has been reviewed by the University Hospitals Sussex Research Champions, including members of the public, patients and patient representatives. It will be shared with participants and their families who expressed an interest in finding out about these results.
We would like to thank all those families who participated for their help in completing a successful trial, the healthcare staff who helped to collect the data, and the families and healthcare staff who gave additional time to participate in the feedback interviews.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0219
Date of REC Opinion
25 Jul 2019
REC opinion
Favourable Opinion