Effects of the Addition of the SIMEOX Device on Autogenic Drainage in Patients With Cystic Fibrosis
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
- Amount of sputum secretion
研究概览
简要总结
This study will investigate the contribution of SIMEOX technology on the effectiveness of bronchial drainage.
This is a crossover study to evaluate the contribution of SIMEOX on the effectiveness of bronchial drainage (verified by the amount of sputum secretions, the rheology of sputum secretions and the subjective sensation of ease of sputum) in patients with cystic fibrosis.
Patients will perform, in randomized order (1) a 30-min session of autogenic drainage, (2) a 30-min session of autogenic drainage with the SIMEOX device. Sputum will be collected during and after the session. The two sessions will be performed with minimum washout time of 24 hours.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with cystic fibrosis
- •Chronic bronchorrhea, able to expectorate by themselves
- •Hospitalized
排除标准
- •Regular use of SIMEOX,
- •Difficulties in understanding instructions,
- •Severe cardiac comorbidity.
结局指标
主要结局
Amount of sputum secretion
时间窗: 30-min
Total wet weight and dry weight of sputum collected in the 24-h following each intervention will be quantified.
Mucus viscoelasticity
时间窗: 30-min
Change in rheological properties of the sputum before and after each intervention will be analyzed using a rheometer. We will use the Rheomuco (Rheonova) reometer to obtain the differences in elasticity (G'), viscosity (G')' and elastic modulus ratio (tanδ) of the secretions collected before and after each intervention.
Subjective feeling of ease to expectorate
时间窗: 3-min
A Visual Analogue Scale (VAS) will be used to measure subjective feeling of ease of expectoration during each intervention. The visual analogue scale (VAS) is a semi-objective rating system that will be used to quantify the subjective feeling of ease to expectorate. The VAS is represented by a horizontal line marked 0 to 10, where "0" indicates "very easy to expectorate" and "10" indicates "not easy to expectorate at all". The lower the score, the easier it is to expectorate.
次要结局
未报告次要终点
研究者
William Poncin, PT, PhD
Principal Investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain