NCT01923753终止2 期
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Actegy Ltd.2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Wet weight of sputum expectorated during treatment session
研究概览
简要总结
This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of CF (established by genotype or sweat sodium >70mmol/l or sweat chloride of >60 mmol/l
- •Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics
排除标准
- •Acute respiratory failure
- •Haemodynamic instability (including severe right heart failure with hypotension)
- •Current severe haemoptysis
- •Ineffective cough
- •Rib fractures
- •Pregnancy
- •Current or recent pneumothorax
- •Current pulmonary embolism
- •Oesophageal varices
- •Recent thoracic upper gastro-intestinal tract or facial surgery
- •Active tuberculosis
- •Recent brain, eye, ear, ENT surgery
- •Myocardial infarction
- •Ascending aortic aneurysm
- •Acute diarrhoea
- •Pulmonary embolism
- •Severe hypertension (systolic >200 mm Hg, diastolic >120 mm Hg)
- •Confusion/dementia
- •Inability to give consent
结局指标
主要结局
Wet weight of sputum expectorated during treatment session
时间窗: up to 30 minutes after treatment
次要结局
- Change in ventilation(5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment)
- Change in FEV1(immediately before and up to 30 minutes after treatment)
- Change in VC(immediately before and up to 30 minutes after treatment)
- Change in oxygen saturation(continuously from 3 minutes prior to treatment and until 3 minutes after treatment)
- Change in neural respiratory drive(5 minutes prior to treatment and 30 minutes after treatment)
研究者
研究点 (2)
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