Multicenter Controlled Trial on Efficacy of TPEP Device in Adult Patients With Chronic Hypersecretion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 9
- 主要终点
- arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
研究概览
简要总结
Mechanical devices to increase the individual's bronchial hygiene are commonly used in patients with chronic retention of secretions and abnormal cough reflex. In this clinical context a new technology (namely TPEP® - Temporary Positive Expiratory Pressure) has been recently developed with the aim to improve the respiratory condition in patients suffering from chronic respiratory diseases. This trial has the aim to assess the clinical efficacy of TPEP in patients with chronic hypersecretion and airways obstruction, but with a normal competence of the cough reflex
详细描述
This is a single-blind multicentre controlled randomized trial with consecutive recruitment. Randomization list by blocks will be available. Group comparison will be made between active therapies including TPEP added to conventional MABT (Intervention) or MABT alone (Control). Active therapy will last 10 consecutive daily sessions in both groups.
Primary outcome
Efficacy comparison on change in:
a.arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
Secondary outcomes
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
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic hypersecretion as defined by > 30 mL/die sputum production (7)
- •chronic airway obstruction (by definition)
- •COPD, bronchiectasis, asthma, cystic disease, etc. with or without chronic respiratory failure
- •adulthood
- •smoking or non-smoking habit
- •Peak Cough Expiratory Flow > 150 L*min-1 (5)
- •willingness to participate
排除标准
- •childhood
- •presence of acute exacerbation
- •severe concomitant cardiovascular diseases
- •concomitant neoplastic diseases
- •non compliance/adherence to TPEP
- •concomitant use of chronic mechanical ventilation
- •use of amynophyllines and/or any active drugs (e.g. N-Acetyl-Cysteine)
结局指标
主要结局
arterial oxygenation (as assessed by PaO2/FiO2 ratio and/or SatO2 index)
时间窗: Day 10
次要结局
- Sputum volume(Day 1 to 10)
- Sputum characteristics(Day 1 to 10)
- Individual's perceived sensation (VAS scale)(Day 1 to 10)
- Lung function (volumes and respiratory muscle performance)(Day 1 - 3 - 10)