Role of Resistive Inspiratory Manoeuvres During Bronchial Drainage Session in Cystic Fibrosis: a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Wet sputum production
研究概览
简要总结
This trial aims to analyze whether the resistive inspiratory manoeuvre (RIM) performed previously to autogenic drainage (AD) technique improves the effectiveness in terms of mucus clearance during a typical bronchial drainage session in adults, stable CF patients.
详细描述
It is a multicenter study. 4 different Spain Cystic Fibrosis Foundations are included in the study (Madrid, Valencia, Murcia and Aragón). All patients will perform three different arms of treatment in a crossover randomization. Each arm of treatment will be apply only in one session. The wash-out period will be one week. Before starting the trial, all patients will perform a control session without any intervention, only the outcome measures will be assess.
During the study period the patients' pharmacological treatment remained unchanged
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l)
- •Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk);
- •Chronic sputum production, at least ≥ 15 ml /24h
- •Familiar and trained in the use of autogenic drainage technique (at least 6 months) and resistive inspiratory manoeuvre (at least three previous sessions)
- •To be able to provide written, informed consent
排除标准
- •Lung function: Forced expiratory volume in 1 second < 30 % pred . ; Forced vital capacity < 40 % pred.
- •Active haemoptysis during the previous month
- •Supplemental oxygen or non-invasive ventilation (NIV)
结局指标
主要结局
Wet sputum production
时间窗: 24 hours
24h wet sputum production (g) after bronchial drainage session
次要结局
- Computerized respiratory sounds(30 minutes)
- Lung function (simply spirometry)(30 minutes)
- Patients´ perception(30 minutes)
- Wet sputum production(30 minutes)