Self-administered Hyperinsufflation Chest Mobilization Randomized Study on the Risk of Low Respiratory Infection in Patients With Multiple Sclerosis With Sputum Capacity Deficit
试验速览
- 阶段
- 不适用
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
研究概览
简要总结
In patients with neuromuscular disease, chest mobilization by hyperinsufflation slows respiratory decline by almost 80% compared to controls, and prevents complications like pneumonia, atelectasis and respiratory distress.
This insufflation technique improves the airway clearance and reduces the need for invasive ventilation. It also improves CV and DEPtoux in patients with neuromuscular pathology
详细描述
During multiple sclerosis (MS), although expiratory involvement and reduced sputum capacity are predominant, automated techniques of hyperinsufflation and in-exsufflation remain underused and undervalued. A single retrospective study suggests a decrease in the decline in respiratory function with regular manual hyperinsufflation.
Evidence of a benefit of chest mobilization by hyperinsufflation by a controlled trial is therefore necessary before recommending its use in MS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Confirmed MS diagnosis (McDonald criteria)
- •Age greater than or equal to 18 years.
- •Expiratory flow during a coughing effort (DEPtoux) ˂4.5L / s.
排除标准
- •ENT and / or thoracic surgery less than 6 months old
- •Progressive or past pneumothorax / pneumomediastinum
- •Severe swallowing disorders.
- •Inability to use the device under study
研究组 & 干预措施
Control group
standardized respiratory management.
干预措施: Standardized respiratory management program (Other)
Experimental group
same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years)
干预措施: Standardized respiratory management program (Other)
Experimental group
same program as control group associated with the daily use of a hyperinsufflation technique (2 times per day during15 minutes, 5 days a week, for 2 years)
干预措施: CoughAssist (Other)
结局指标
主要结局
Effectiveness of a self-administered automated hyperinsufflation technique for 2 years, versus standard management, on respiratory infection risk within 2 years after randomization, in patients with MS.
时间窗: 24 months
This will be evaluated by the incidence of lower respiratory infections requiring antibiotic therapy
次要结局
- Functional effectiveness of COUGH-ASSIST(12 months and 24 months)
- Effect of COUGH-ASSIST on slowing the decline in respiratory function,(12 months and 24 months)
- Tolerance and compliance with COUGH-ASSIST,(24 months)
- Effectiveness of COUGH-ASSIST in reducing the risk of serious respiratory infection(24 months)