The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- measurement of Sputum production
研究概览
简要总结
The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Bronchiectasis on HRCT
- •Optimization of Therapy for at least 15 days before enrollment
- •Autonomous patients with possibilities of practicing rehabilitations cycles
排除标准
- •OSAS (ODI>10/h)
- •PH<7,35 - paO2< 60mmHg, paCo2> 55 mmHg
- •Lung cancer
- •Contraindication to high-flow nasal cannula (hfnc)
研究组 & 干预措施
Therapy with high flow humidification
The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations
干预措施: High Flow Humidification (Device)
Therapy with usual care
The patients will be under usual care for observational
结局指标
主要结局
measurement of Sputum production
时间窗: 1 year
Microbiological Mesurement of sputum
time from first exacerbations
时间窗: 1 year
measurement of time dalay from last exacerbation
Improvment Daily Life
时间窗: 1 year
measurement via questionary SGRQ
Number of missed working or school day
时间窗: 1 year
Calculation of days of sick
number of exacerbations including their durations and severity
时间窗: 1 year
counting form their clinic diary of number of exacerbation
measurement Exercise tolerance
时间窗: 1 year
measurement with 6 minutes walking test
次要结局
- Unit of Nitric Oxide(1 year)
- Evaluation of Arterial Blood Glass(1 year)
- Evaluation of Reactive C-Protein(1 year)
研究者
Dr. Giuseppe Fiorentino
Director Giuseppe Fiorentino
Monaldi Hospital