NCT02847299已完成不适用
Comparison of a Hyperinflation Mode and Air Stacking on Neuromuscular Patients Under Volumetric Ventilation
Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Peak cough flow
研究概览
简要总结
The purpose of the study is to compare the the efficacy and tolerance of 2 cough assistance techniques requiring no equipment other than the volumetric fan. The two methods are air-stacking and hyperinflation .
The study is a Cross-over, monocentric and open label study
详细描述
Primary outcome : Peak Expiratory Flow (PEF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years, neuromuscular disease,
- •restrictive syndrome and/or cough peak flow < 270.l/mn and/or maximal expiratory pressure < 40 cm HO2,
- •patient under non invasive ventilation
- •steady state for at least one month
- •written consent form given
排除标准
- •bronchial congestion
- •hemodynamic instability
- •previous pneumothorax or emphysema bubbles
- •Major bulbar dysfunction
- •plan of legal protection
- •pregnant or breastfeeding women
- •no affiliation to a social security scheme
结局指标
主要结局
Peak cough flow
时间窗: 1 year
次要结局
- maximal expired volume(1 year)
- respiratory comfort (Visual Analog Scale)(1 year)
- inspired volume(1 year)
- effective cough time(1 year)
- subjective patient's effectiveness of cough (Visual Analog Scale)(1 year)
研究者
研究点 (2)
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