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. 2024 Oct 7;10(5):00168-2024.
doi: 10.1183/23120541.00168-2024. eCollection 2024 Sep.

High-flow humidified oxygen as an early intervention in children with acute severe asthma: a feasibility randomised controlled trial

Akshat Kapur  1 , Héctor Rojas-Anaya  1   2   3 , Graham Roberts  4 , Damian Roland  5 , Atul Gupta  6 , Michaela Lazner  1 , Jane Bayreuther  7   8 , Fleur Cantle  6 , Christina Jones  9 , John Pappachan  7   8 , Stephen Bremner  2   3 , David James  7   8 , Shane Fitzgerald  5 , Kelly Owens  1 , Lalarukh Asim  6 , Ekaterina Khaleva  4 , Paul Seddon  1
Affiliations

High-flow humidified oxygen as an early intervention in children with acute severe asthma: a feasibility randomised controlled trial

Akshat Kapur et al. ERJ Open Res. .

Abstract

Background: Treating children with acute severe asthma (ASA) who fail to respond to first-line inhaled bronchodilators is problematic: use of intravenous agents is inconsistent and side-effects are common. High-flow humidified oxygen (HiFlo) has shown promise in other respiratory conditions and is increasingly used in ASA, but with little evidence.

Methods: We conducted a feasibility randomised controlled trial with deferred consent to assess early HiFlo in children aged 2-11 years with ASA not responding to "burst" therapy (high-dose inhaled salbutamol ± ipratropium). Children with Paediatric Respiratory Assessment Measure (PRAM) score 5+ after "burst" were randomised to commence HiFlo or follow standard care. Candidate primary outcomes assessed were treatment failure requiring escalation, and time to meeting hospital discharge criteria.

Results: The target was met despite coronavirus disease 2019 pandemic disruption: 56 children were randomised across four sites, with deferred consent received in 50 out of 56 (89%), and mean recruitment rate 1.1 per site per month. 28 were allocated early HiFlo and 22 standard care. Data collection was complete for both candidate primary outcomes. Treatment failure requiring escalation occurred in 18 of 28 children (64%) in the HiFlo arm and in 19 of 22 (86%) in the standard care arm. Median (interquartile range) time from randomisation to meeting discharge criteria was 29.3 h (21.8-43.7 h) in the HiFlo arm and 36.8 h (24.1-46.3 h) in the standard care arm.

Conclusions: HiFlo in childhood ASA is a potentially promising intervention whose use is increasing despite lack of evidence. A definitive randomised controlled trial to assess its effectiveness is required and appears to be feasible.

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Conflict of interest statement

Conflict of interest: A. Kapur has nothing to disclose. Conflict of interest: H. Rojas-Anaya has nothing to disclose. Conflict of interest: G. Roberts has nothing to disclose. Conflict of interest: D. Roland has nothing to disclose. Conflict of interest: A. Gupta has nothing to disclose. Conflict of interest: M. Lazner was an advisory board member for Aerogen Ltd for non-HiFlo study-related research and received an honorarium of £952.89 for this work. Conflict of interest: J. Bayreuther has nothing to disclose. Conflict of interest: F. Cantle has nothing to disclose. Conflict of interest: C. Jones has nothing to disclose. Conflict of interest: J. Pappachan has nothing to disclose. Conflict of interest: S. Bremner has nothing to disclose. Conflict of interest: D. James has nothing to disclose. Conflict of interest: S. Fitzgerald has nothing to disclose. Conflict of interest: K. Owens has nothing to disclose. Conflict of interest: L. Asim has nothing to disclose. Conflict of interest: E. Khaleva has nothing to disclose. Conflict of interest: P. Seddon, in March 2023, chaired an advisory board (unrelated to HiFlo) for Aerogen Ltd, which loaned nebuliser equipment for the study, and received an honorarium.

Figures

FIGURE 1
FIGURE 1
Study flow chart. Rx: treatment; PRAM: Paediatric Respiratory Assessment Measure; HiFlo: high-flow humidified oxygen; i.v.: intravenous; FIO2: fraction of inspired oxygen; RR: respiratory rate; HR: heart rate; PCO2: carbon dioxide tension; NIV: noninvasive ventilation; SpO2: oxygen saturation by pulse oximeter; TC: time of meeting discharge criteria; TD: time of discharge.
FIGURE 2
FIGURE 2
CONSORT diagram. HiFlo: high-flow humidified oxygen; HDU: high-dependency unit.
FIGURE 3
FIGURE 3
Kaplan–Maier curves for time between randomisation and readiness for discharge. HiFlo: high-flow humidified oxygen.
See this image and copyright information in PMC

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