Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
研究概览
简要总结
Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •consent form signature
- •Men and women aged over or equal to 18 years old
- •Medical examination before the research
- •Negative results of tests of pregnancy for the women at age to procreate or taking an effective contraceptive
- •Patients with neuromuscular pathologies without tracheostmy - Vital Capacity < 80% of theoretical value
排除标准
- •Refuse to participate at the research
- •Patient under guardianship or under trusteeship
- •pregnant Women
- •Patients unable to cooperate
- •Patients without a security social scheme (as beneficiary or bearer of rights)
- •Usual contra-indications for an insufflation (haemoptise, recent pneumothorax, pulmonary emphysema, pleuresy, nausea, chronic obstructive pulmonary diseasee or asthma, recent lobectomy, intracranial hypertension, troubles of consciousness, unable to talk)
结局指标
主要结局
Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
时间窗: 30 minutes
次要结局
未报告次要终点