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

High-flow humidified oxygen as an early intervention in children with acute severe asthma: a feasibility randomised controlled trial
High-flow humidified oxygen as an early intervention in children with acute severe asthma: a feasibility randomised controlled trial
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.
2312-0541
Kapur, Akshat
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Rojas-Anaya, Héctor
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Roberts, Graham
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Roland, Damian
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Gupta, Atul
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Lazner, Michaela
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Bayreuther, Jane
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Cantle, Fleur
329ed508-ce40-4df7-a28d-4d227ead3702
Jones, Christina
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Pappachan, John
8e1bd6bd-1cb9-4dd9-a9af-b9eed5459148
Bremner, Stephen
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James, David
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Fitzgerald, Shane
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Owens, Kelly
179a882f-13e8-48ce-9654-177ef660011b
Asim, Lalarukh
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Khaleva, Ekaterina
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Seddon, Paul
fdb1c747-7da5-4b20-8d81-97ff36edfb5b
Kapur, Akshat
b6243400-bb1d-40da-a1c9-3d1cf9ae4525
Rojas-Anaya, Héctor
c15c5a92-f6e3-41a7-9971-ac4fa1f6fb90
Roberts, Graham
ea00db4e-84e7-4b39-8273-9b71dbd7e2f3
Roland, Damian
bac42549-2249-4b39-b272-4d11f451574a
Gupta, Atul
ef653ca8-50c8-4aab-a094-68e8c9879242
Lazner, Michaela
8324b7a4-6d17-4630-a7cf-d9b31d585b15
Bayreuther, Jane
1aeedbb3-4018-458c-9533-d0e2f6c2c5fe
Cantle, Fleur
329ed508-ce40-4df7-a28d-4d227ead3702
Jones, Christina
137b4a87-3cce-470c-a895-33ea55b4f880
Pappachan, John
8e1bd6bd-1cb9-4dd9-a9af-b9eed5459148
Bremner, Stephen
0e117fa6-27ea-41cc-9523-70f90cd65bc0
James, David
6607bafb-c9f0-413c-9d41-a8366fbd61a5
Fitzgerald, Shane
3069fd28-1315-4a70-b1a3-081ea6698cd3
Owens, Kelly
179a882f-13e8-48ce-9654-177ef660011b
Asim, Lalarukh
675346b5-3e9e-4ff4-8055-2e4322664927
Khaleva, Ekaterina
0143fad8-e8b7-4286-997b-368a23488ca8
Seddon, Paul
fdb1c747-7da5-4b20-8d81-97ff36edfb5b

Kapur, Akshat, Rojas-Anaya, Héctor, Roberts, Graham, Roland, Damian, Gupta, Atul, Lazner, Michaela, Bayreuther, Jane, Cantle, Fleur, Jones, Christina, Pappachan, John, Bremner, Stephen, James, David, Fitzgerald, Shane, Owens, Kelly, Asim, Lalarukh, Khaleva, Ekaterina and Seddon, Paul (2024) High-flow humidified oxygen as an early intervention in children with acute severe asthma: a feasibility randomised controlled trial. ERJ Open Research, 10 (5), [00168-2024]. (doi:10.1183/23120541.00168-2024).

Record type: Article

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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ERJ Open Res-2024-Kapur-00168-2024 - Version of Record
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Accepted/In Press date: 1 May 2024
e-pub ahead of print date: 7 October 2024

Identifiers

Local EPrints ID: 495548
URI: http://eprints.soton.ac.uk/id/eprint/495548
ISSN: 2312-0541
PURE UUID: f8382ca1-56d6-456f-854b-ee65c9f1a19c
ORCID for Graham Roberts: ORCID iD orcid.org/0000-0003-2252-1248
ORCID for Ekaterina Khaleva: ORCID iD orcid.org/0000-0002-2220-7745

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Date deposited: 18 Nov 2024 17:30
Last modified: 19 Nov 2024 02:58

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Contributors

Author: Akshat Kapur
Author: Héctor Rojas-Anaya
Author: Graham Roberts ORCID iD
Author: Damian Roland
Author: Atul Gupta
Author: Michaela Lazner
Author: Jane Bayreuther
Author: Fleur Cantle
Author: Christina Jones
Author: John Pappachan
Author: Stephen Bremner
Author: David James
Author: Shane Fitzgerald
Author: Kelly Owens
Author: Lalarukh Asim
Author: Ekaterina Khaleva ORCID iD
Author: Paul Seddon

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