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临床试验/NCT02137304
NCT02137304已完成不适用

A Method to Optimize Mecanical In-exsufflation in Neuromuscular Diseases

Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年2月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
optimal negative pressure treshold value

研究概览

简要总结

The investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

详细描述

he investigators want to demonstrate that there is an optimal expiratory pressure when using mecanical in-exsufflation for each patient in neuromuscular disease. This compromise is between the need to generate a high pressure difference between alveoli and the mouth and the need to avoide and superior airways collapsus.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • man or female age18 years
  • neuromuscular disease
  • coughassist adaptation treatment
  • peak cough flow<270liter/minute

排除标准

  • acute organ failure
  • insufflation contrindication
  • pregnant women/no affiliation to a social security scheme
  • plan of legal protection

研究组 & 干预措施

neuromuscular patients

Experimental

Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)

干预措施: Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) (Device)

结局指标

主要结局

optimal negative pressure treshold value

时间窗: 20 minutes

Optimal negative pressure treshold value measured for a flow superior or equal to 160 liter/minute and 270 liter/minute

次要结局

  • optimal pressure treshold based on the best peak flow.(10 minutes)
  • volume-flow curve aspect(5 minutes)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (2)

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