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

IF 4.3 3区 医学 Q1 RESPIRATORY SYSTEM ERJ Open Research Pub Date : 2024-10-07 eCollection Date: 2024-09-01 DOI:10.1183/23120541.00168-2024
Akshat Kapur, Héctor Rojas-Anaya, Graham Roberts, Damian Roland, Atul Gupta, Michaela Lazner, Jane Bayreuther, Fleur Cantle, Christina Jones, John Pappachan, Stephen Bremner, David James, Shane Fitzgerald, Kelly Owens, Lalarukh Asim, Ekaterina Khaleva, Paul Seddon
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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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高流量湿化氧气作为急性重症哮喘患儿的早期干预措施:可行性随机对照试验。
背景:治疗对一线吸入性支气管扩张剂无效的急性重症哮喘(ASA)患儿很成问题:静脉注射药物的使用不一致,副作用也很常见。高流量湿化氧气(HiFlo)已在其他呼吸系统疾病中显示出前景,并越来越多地用于急性重症哮喘,但证据不足:我们进行了一项获得延期同意的可行性随机对照试验,以评估早期 HiFlo 在对 "爆发 "疗法(大剂量吸入沙丁胺醇和异丙托品)无效的 2-11 岁 ASA 儿童中的应用情况。对 "爆发 "治疗后儿科呼吸评估量表(PRAM)评分为 5 分以上的儿童随机分配开始 HiFlo 或接受标准治疗。评估的主要候选结果是需要升级的治疗失败和达到出院标准的时间:结果:尽管冠状病毒疾病引发了 2019 年的大流行,但仍达到了目标:四个地点的 56 名儿童接受了随机治疗,56 人中有 50 人(89%)获得了延期同意,平均招募率为每个地点每月 1.1 人。28 名儿童被分配到早期 HiFlo,22 名儿童被分配到标准护理。两个候选主要结果的数据收集工作均已完成。HiFlo治疗组的28名患儿中有18名(64%)治疗失败,标准治疗组的22名患儿中有19名(86%)治疗失败。从随机化到达到出院标准的中位时间(四分位数间距),HiFlo治疗组为29.3小时(21.8-43.7小时),标准治疗组为36.8小时(24.1-46.3小时):儿童 ASA 中的 HiFlo 是一种具有潜在前景的干预措施,尽管缺乏证据,但其使用率正在不断增加。需要进行一项明确的随机对照试验来评估其有效性,这项试验似乎是可行的。
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来源期刊
ERJ Open Research
ERJ Open Research Medicine-Pulmonary and Respiratory Medicine
CiteScore
6.20
自引率
4.30%
发文量
273
审稿时长
8 weeks
期刊介绍: ERJ Open Research is a fully open access original research journal, published online by the European Respiratory Society. The journal aims to publish high-quality work in all fields of respiratory science and medicine, covering basic science, clinical translational science and clinical medicine. The journal was created to help fulfil the ERS objective to disseminate scientific and educational material to its members and to the medical community, but also to provide researchers with an affordable open access specialty journal in which to publish their work.
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