NCT06393257招募中不适用
Efficacy and Safety of Airway Clearance Technique by Oscillation and Lung Expansion in Patients With Bronchiectasis
Shanghai Pulmonary Hospital, Shanghai, China3 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 3
- 主要终点
- sputum volume in 24h
研究概览
简要总结
The goal of this prospective randomized controlled trial is to explore the efficacy and safety of Oscillation and Lung Expansion-a airway clearance technology-in bronchiectasis. Participants will receive Oscillation and Lung Expansion or postural drainage randomly in this study. and the symptom, quality of life scores and amount of expectoration will be compared between the two groups.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute exacerbation of bronchiectasis
排除标准
- •Haemoptysis greater than 50ml
- •state of endangerment
- •pneumothorax
- •Lung surgery history within 6 months
- •Severe heart, brain and nervous system diseases
研究组 & 干预措施
Oscillation and Lung Expansion
Experimental
干预措施: Oscillation and Lung Expansion (Device)
Oscillation and Lung Expansion
Experimental
干预措施: Anti-infective therapy (Drug)
Oscillation and Lung Expansion
Experimental
干预措施: Mucolytic (Drug)
postural drainage
Active Comparator
干预措施: Postural drainage (Behavioral)
postural drainage
Active Comparator
干预措施: Anti-infective therapy (Drug)
postural drainage
Active Comparator
干预措施: Mucolytic (Drug)
结局指标
主要结局
sputum volume in 24h
时间窗: 2 weeks
次要结局
- Bronchiectasis exacerbation and symptom tool(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
- Quality of life questionnaire-bronchiectasis(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
- Leicester Cough Questionnaire(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
- Bronchiectasis Health Questionnaire(Assessed at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks post-discharge)
- Time to the first bronchiectasis exacerbation since randomization(Assessed at 4 weeks, 8 weeks and 12 weeks post-discharge)
研究者
Jin-Fu Xu
Professor
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (3)
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