Evaluation of the Short-term Use of Selected PEP and OPEP Devices in Cystic Fibrosis Patients During an Exacerbation of the Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pulmonary Function. Measured indicators: FEV1, FVC
研究概览
简要总结
Cystic fibrosis (CF) is the most common severe autosomal recessive genetic disease in Caucasians. The CFTR (cystic fibrosis transmembrane regulator) gene, which encodes the chloride channel of the epithelial cell membrane, is responsible for the development of the disease. Respiratory physiotherapy, especially bronchial drainage is one of the basic elements of comprehensive management in patients with CF. Among the many procedures used in CF drainage physiotherapy, the most commonly include these using positive expiratory pressure (PEP) and oscillating positive expiratory pressure (OPEP). The aim of the study is to assess the efficacy of the usage of selected PEP and OPEP devices in bronchial drainage in cystic fibrosis patients during exacerbation of the disease.
详细描述
The aim of the study is to assess the efficacy of the short-term (4-days) use of selected devices generating positive expiratory pressure (PEP device: PARI PEP® S System) and oscillating positive expiratory pressure (OPEP devices: Aerobika* OPEP Device and PARI O-PEP Device commonly called: Flutter) in bronchial drainage in cystic fibrosis patients during exacerbation of the disease. Patients will perform bronchial drainage in three different groups using different devices in each of them. The main questions study aims to answer are: 1. Whether the devices used are effective in bronchial drainage in patients with cystic fibrosis, 2. Are there differences in efficiency between the devices used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written consent of the patient and/or guardian, age over 12, no disease complications (within the last 2 months) in the form of: active haemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
- •the ability to perform correctly lung function tests and FEV1 value above 20% predicted,
- •the presence of respiratory symptoms indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in FEV1 by 10% or more from a previously recorded value.
排除标准
- •lack of written consent of the patient and/or guardian, age below 12, occurrence of disease complications (within the last 2 months) in the form of: active hemoptysis, pneumothorax, chest surgeries, surgical procedures in the area of the esophagus (esophageal varices), otitis media,
- •inability to perform lung function tests, FEV1 value below 20% of predicted value,
- •PEP, OPEP device intolerance,
- •no symptoms of the respiratory system indicating exacerbation of the disease, i.e. increasing of cough, increasing of dyspnoea, decrease in in FEV1 less than 10% from a previously recorded value.
结局指标
主要结局
Pulmonary Function. Measured indicators: FEV1, FVC
时间窗: Baseline and the day 4
Volume measurement (L). Change from baseline to day 4
Sputum expectorated
时间窗: from the 1st to the 4th day
Volume measurement (ml)
Pulmonary Function. Measured indicators: FEF75
时间窗: Baseline and the day 4
Volume and flow measurement (L/s). Change from baseline to day 4
次要结局
未报告次要终点