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Pilot observational cohort study to determine whether waveform and flow traces from mechanical insufflation–exsufflation (MI-E) can be used to identify laryngeal responses to MI-E and thus optimise treatment algorithms in neuromuscular patients in a tertiary centre: a protocol description
BMJ Open Respiratory Research ( IF 4.1 ) Pub Date : 2024-03-01 , DOI: 10.1136/bmjresp-2022-001599
Stephanie K Mansell , Rhiannon Parry , Amar Shah , Francesca Gowing , Charlotte Greenfield , Yogesh Bhatt , Swapna Mandal

Introduction Patients with neuromuscular disease often have a weak and ineffective cough due to respiratory muscle weakness. One treatment option is mechanical insufflation–exsufflation (MI-E), also known as cough assist, which is known to increase cough strength. However, some patients have a laryngeal response to MI-E, which can make the treatment ineffective. Currently, the only method for assessing this is via nasal endoscopy while using MI-E. Some MI-E devices have onboard secure data (SD) cards, which allow the visualisation of waveforms. We hypothesise that the waveforms can be used to identify laryngeal responses to the MI-E. Methods and analysis Participants will complete baseline assessments of spirometry, peak cough flow and sniff nasal inspiratory pressure. A nasal endoscope will be used to visualise the larynx during simultaneous MI-E via a mask with a drilled hole. MI-E will be delivered by an experienced physiotherapist. Four cycles of MI-E at a range of prescriptions will be delivered. MI-E waveforms will be downloaded into Care Orchestrator Essence software (Philips, Murraysville). Data will be collected prospectively and reviewed in a descriptive context, providing trends and potential rationales describing the waveforms in comparison to the nasal endoscope videos. Ethics and dissemination This protocol has been reviewed by the East of England-Cambridge Central Research Ethics Committee, who have granted a favourable ethical opinion. The study opened to recruitment in January 2022 and aims to publish trial results in June 2024. Trial registration number [NCT05189600][1]. No data are available. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05189600&atom=%2Fbmjresp%2F11%2F1%2Fe001599.atom

中文翻译:

试点观察性队列研究,以确定机械吹气-吹气 (MI-E) 的波形和流量轨迹是否可用于识别喉部对 MI-E 的反应,从而优化三级中心神经肌肉患者的治疗算法:方案描述

简介 神经肌肉疾病患者常因呼吸肌无力而出现无力且无效的咳嗽。一种治疗选择是机械吹气-排气(MI-E),也称为咳嗽辅助,众所周知,它可以增加咳嗽强度。然而,一些患者对 MI-E 有喉部反应,这可能会使治疗无效。目前,评估这一点的唯一方法是使用 MI-E 时通过鼻内窥镜检查。一些 MI-E 设备具有板载安全数据 (SD) 卡,可实现波形可视化。我们假设波形可用于识别喉部对 MI-E 的反应。方法和分析 参与者将完成肺活量测定、峰值咳嗽流量和鼻吸气压力的基线评估。在同时进行 MI-E 期间,将使用鼻内窥镜通过带有钻孔的面罩观察喉部。MI-E 将由经验丰富的物理治疗师进行。将提供四个周期的一系列处方的 MI-E。MI-E 波形将下载到 Care Orchestrator Essence 软件(Philips,Murraysville)中。将前瞻性地收集数据并在描述性背景下进行审查,提供与鼻内窥镜视频相比描述波形的趋势和潜在原理。伦理与传播 该方案已经过英格兰东部-剑桥中央研究伦理委员会的审查,并给予了有利的伦理意见。该研究于2022年1月开始招募,计划于2024年6月发布试验结果。试验注册号[NCT05189600][1]。无可用数据。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05189600&atom=%2Fbmjresp%2F11%2F1%2Fe001599.atom
更新日期:2024-03-01
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