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慢性阻塞性肺疾病急性加重期患者急性有氧运动期间高流量鼻导管治疗的效果:一项随机、对照、交叉试验方案

Effect of high-flow nasal therapy during acute aerobic exercise in patients with chronic obstructive pulmonary disease after exacerbation: protocol for a randomised, controlled, cross-over trial.

作者信息

Prieur Guillaume, Medrinal Clement, Combret Yann, Quesada Aurora Robledo, Prieur Fabrice, Quieffin Jean, Borel Jean Christian, Reychler Gregory

机构信息

Pulmonology Department and Pulmonary Rehabilitation Department, Groupe Hospitalier du Havre, Montivilliers, France.

Normandie UnivRouen France Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.

出版信息

BMJ Open Respir Res. 2017 Aug 16;4(1):e000191. doi: 10.1136/bmjresp-2017-000191. eCollection 2017.

Abstract

INTRODUCTION

Early pulmonary rehabilitation is recommended after a severe exacerbation of chronic obstructive pulmonary disease (COPD). However, this is difficult to implement, particularly for exercise training. High-flow nasal therapy (HFNT) may reduce the work of breathing and dyspnoea and may improve exercise tolerance.

METHODS AND ANALYSIS

This is a single-centre, prospective, controlled, randomised, cross-over study. Eligible patients will have a diagnosis of COPD (postbronchodilator forced expiratory volume in 1 s/forced vital capacity ratio of <0.7). Two constant work rate exercise tests at 80% of the peak work rate will be carried out on two consecutive days with and without HFNT. The primary outcome will be the difference in endurance time between the two conditions. Secondary outcomes will be the change in muscle oxygenation during exercise, dyspnoea and muscle fatigue, respiratory muscle strength after exercise, respiratory rate, cardiac frequency, transcutaneous CO pressure and pulsed O saturation. Nineteen patients will be included. Data will be analysed as intention to treat by a blinded statistician.

ETHICS AND DISSEMINATION

Ethics approval has been obtained from the Ethics Committees Nord-Ouest III, Caen, France (N° ID RCB: 2016-A01325-46). The study will begin in April 2017 for a duration of 2 years. The results of the trial will be presented at national and international meetings and published in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

NCT03058081.

摘要

引言

慢性阻塞性肺疾病(COPD)严重加重后,建议尽早进行肺康复治疗。然而,这很难实施,尤其是运动训练。高流量鼻导管治疗(HFNT)可能会减少呼吸功和呼吸困难,并可能提高运动耐力。

方法与分析

这是一项单中心、前瞻性、对照、随机、交叉研究。符合条件的患者将被诊断为COPD(支气管扩张剂使用后1秒用力呼气容积/用力肺活量比值<0.7)。将在连续两天内分别在有和没有HFNT的情况下,以峰值工作率的80%进行两次恒定工作率运动测试。主要结局将是两种情况下耐力时间的差异。次要结局将包括运动期间肌肉氧合的变化、呼吸困难和肌肉疲劳、运动后呼吸肌力量、呼吸频率、心率、经皮二氧化碳分压和脉搏血氧饱和度。将纳入19名患者。数据将由一位盲态统计学家按意向性分析进行分析。

伦理与传播

已获得法国卡昂西北三区伦理委员会的伦理批准(编号:ID RCB:2016 - A01325 - 46)。该研究将于2017年4月开始,为期2年。试验结果将在国内和国际会议上展示,并发表在同行评审期刊上。

试验注册号

NCT03058081。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/241b/5647475/3a46e44c672c/bmjresp-2017-000191f01.jpg

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