Hypersecreting Patients (COPD And/or Bronchiectasic) Comparing 2 Technologies: Efa vs Efa + High Flow
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Expectoration Difficulty
研究概览
简要总结
The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosed by spirometry
- •Bronchiectasis diagnosed by CT
- •2 Exacerbation/year
排除标准
- •Cystic Fibrosis
- •Non Invasive Ventilation
- •Ineffective Cough
- •Exacerbation in progress
- •Hemodynamic Instability
- •severe heart failure
研究组 & 干预措施
Expiratory Flow Accelerator
Patients for 6 weeks use the Expiratory Flow Accelerator Technology
干预措施: Bronchial Clearance A (Device)
Expiratory Flow Accelerator + HIGH FLOW Technology
Patients for 6 weeks use the EFA technology and High Flow Technology
干预措施: Bronchial Clearance B (Device)
结局指标
主要结局
Expectoration Difficulty
时间窗: "Day0", "Week6", Week13"
Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty)
Cough Severity
时间窗: "Day0", "Week6", Week13"
Visual Analogic Scale (0=not severe cough;10=very severe cough)
次要结局
- Exacerbations("Day0", "Week6", Week13")
- Inspiratory Capacity("Day0", "Week6", Week13")
- SpO2 (Oxygen Saturation by Pulse Oximetry)("Day0", "Week6", Week13")
- FEV 1 (Forced Expiratory Volume)("Day0", "Week6", Week13")
- 6 minutes walking test("Day0", "Week6", Week13")
- Saint George Respiratory Questionnaire("Day0", "Week6", Week13")
- Medical Research Council mMRC("Day0", "Week6", Week13")
研究者
MARIANNA MESSINA
Principal Investigator
Azienda Socio Sanitaria Territoriale della Valle Olona