Clemm Hege, Røksund Ola D, Andersen Tiina, Heimdal John-Helge, Karlsen Tom, Hilland Magnus, Fretheim-Kelly Zoe, Hufthammer Karl Ove, Sandnes Astrid, Hjelle Sigrun, Vollsæter Maria, Halvorsen Thomas
Department of Clinical Science, University of Bergen, Bergen, Norway.
Department of Pediatric and Adolescent Medicine, Haukeland University Hospital, Bergen, Norway.
Front Pediatr. 2022 Feb 7;10:817003. doi: 10.3389/fped.2022.817003. eCollection 2022.
Exercise-induced laryngeal obstruction (EILO) is a common cause of exertional breathing problems in young individuals, caused by paradoxical inspiratory adduction of laryngeal structures, and diagnosed by continuous visualization of the larynx during high-intensity exercise. Empirical data suggest that EILO consists of different subtypes, possibly requiring different therapeutic approaches. Currently applied treatments do not rest on randomized controlled trials, and international guidelines based on good evidence can therefore not be established. This study aims to provide evidence-based information on treatment schemes commonly applied in patients with EILO.
Consenting patients consecutively diagnosed with EILO at Haukeland University Hospital will be randomized into four non-invasive treatment arms, based on promising reports from non-randomized studies: (A) standardized information and breathing advice only (IBA), (B) IBA plus inspiratory muscle training, (C) IBA plus speech therapy, and (D) IBA plus inspiratory muscle training and speech therapy. Differential effects in predefined EILO subtypes will be addressed. Patients failing the non-invasive approach and otherwise qualifying for surgical treatment by current department policy will be considered for randomization into (E) standard or (F) minimally invasive laser supraglottoplasty or (G) no surgery. Power calculations are based on the main outcomes, laryngeal adduction during peak exercise, rated by a validated scoring system before and after the interventions.
The study will assess approaches to EILO treatments that despite widespread use, are insufficiently tested in structured, verifiable, randomized, controlled studies, and is therefore considered ethically sound. The study will provide knowledge listed as a priority in a recent statement issued by the European Respiratory Society, requested by clinicians and researchers engaged in this area, and relevant to 5-7% of young people. Dissemination will occur in peer-reviewed journals, at relevant media platforms and conferences, and by engaging with patient organizations and the healthcare bureaucracy.
运动性喉梗阻（EILO）是年轻个体运动性呼吸问题的常见原因，由喉结构的矛盾性吸气内收引起，通过在高强度运动期间持续观察喉部来诊断。经验数据表明，EILO由不同亚型组成，可能需要不同的治疗方法。目前应用的治疗方法并非基于随机对照试验，因此无法制定基于充分证据的国际指南。本研究旨在提供关于EILO患者常用治疗方案的循证信息。
在豪克兰大学医院连续诊断为EILO的同意参与研究的患者，将根据非随机研究的有前景报告随机分为四个非侵入性治疗组：（A）仅标准化信息和呼吸建议（IBA），（B）IBA加吸气肌训练，（C）IBA加言语治疗，以及（D）IBA加吸气肌训练和言语治疗。将探讨预定义EILO亚型中的差异效应。对于非侵入性方法治疗失败且根据当前科室政策符合手术治疗条件的患者，将考虑随机分为（E）标准手术或（F）微创激光声门上成形术或（G）不手术。功效计算基于主要结局，即干预前后通过经过验证的评分系统评估的运动峰值时的喉部内收情况。
该研究将评估EILO治疗方法，尽管这些方法广泛使用，但在结构化、可验证、随机对照研究中的测试尚不充分，因此被认为在伦理上是合理的。该研究将提供欧洲呼吸学会最近一份声明中列为优先事项的知识，这是该领域的临床医生和研究人员所要求的，并且与5%至7%的年轻人相关。传播将通过同行评审期刊、相关媒体平台和会议，以及与患者组织和医疗保健管理部门合作来进行。
