Instrumental and Manual Increase of Couch in Neuromuscular Patients: Effects of Different Techniques on the Generated Flow
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
- cough flow obtained from the combination of mechanical and manual cough assistance techniques
研究概览
简要总结
Inefficient cough is responsible of respiratory complications in neuromuscular patients which can lead to hospitalisation and can be life threatening. Techniques enhancing cough efficiency are successful in improving the clearance of bronchial secretions and help non invasive ventilation efficiency especially in case of acute respiratory failure. Combining mechanical exsufflation to the manual techniques of physiotherapy might enhance efficiency. Therefore the investigators want to compare cough efficiency under different techniques of instrumental and manual of cough assistance in order to determine the best combination to optimize cough flow.
详细描述
Hypothesis
Cough inefficiency in neuromuscular patients increases morbidity and mortality in case of airway infections and may lead to invasive ventilation. The use of techniques enhancing cough have been successful in improving the success of non invasive ventilation. We want to determine whether adding manual physiotherapist techniques to mechanical exsufflation improve cough efficiency and its ability to clear bronchial secretions.
Objectives: To compare cough flows obtained with different combination of the use of increased inspiratory capacity technique, mechanical insufflation-exsufflation technique and manually applied pressures techniques.
Method:open monocentric cross-over study (the patients are their own controls). Five combinations of cough increase techniques are compared Inclusion criteria: adult neuromuscular patients with a cough inefficiency at a stable state upon inclusion.
As this is a pilot study, 20 patients from the home ventilation unit of the intensive care of the Raymond Poincare teaching hospital (Garches, France) will be included during the usual follow-up of chronic respiratory failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 否
入选标准
- •adult patients
- •neuromuscular disorders with a respiratory restrictive syndrome (VC < 40% and/or cough flow < 180 L/min and/or Pe max < 40 cmH2O)
- •non invasive ventilation
- •stable respiratory state > 1 month before inclusion
- •signed informed consent form
排除标准
- •unstable respiratory state with increased bronchial secretions
- •unstable hemodynamics
- •pneumothorax and or emphysema
- •tracheostomy
- •major bulbar involvement with swallowing dysfunction with the liquids
- •Persons under Guardianship or Trusteeship
- •Pregnant women
- •not covered by the social security system
- •refusal of study participation
结局指标
主要结局
cough flow obtained from the combination of mechanical and manual cough assistance techniques
时间窗: 2 Hours
次要结局
- duration of efficient cough flow (above 180 l/min)under each cough assistance technique(2 Hours)
- respiratory comfort(2 Hours)
- subjective evaluation of cough efficiency(2 Hours)
- Respiratory comfort(2 Hours)