NCT02061852终止不适用
Prospective Trial for the Evaluation of Safety, Tolerability and Efficacy of the Medical Device Simeox ® Compared to Traditional Respiratory Physiotherapy Techniques for Airway Secretion Clearance
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Safety of the simeox®
研究概览
简要总结
The purpose of this study is to determine whether the medical device "simeox" is safe in the treatment of respiratory diseases, in comparison with traditional physiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18, male or female.
- •Patient affected by broncho-degenerative disease, chronic obstructive airway disease, cystic fibrosis, idiopathic bronchiectasis, ciliary dyskinesia and/or chronic bronchitis.
- •Hospitalization for a minimum of five days or a maximum of 8 days.
- •Bronchial clearance is usually productive.
- •FVC and / or FEV <85% predicted, with stable lung function.
- •Agreement to participate to the study and signature of the informed consent form
- •Social security coverage.
排除标准
- •Patient infected with bacteria resistant to antibiotics.
- •Bronchial clearance is not usually productive.
- •Patient with contra-indication for physiotherapy bronchial clearance.
- •Patient who received a lung transplant.
- •Care requires more than 2 sessions of chest physiotherapy daily.
- •Duration of mechanical ventilation > 8h/day.
- •Patient with an episode of hemoptysis during the month before inclusion.
- •Patient with an episode of pneumothorax during the last month.
- •Pregnant or lactating women.
- •Patient with a disability and/or unwillingness to follow protocol requirements.
- •Patient participating in another clinical study or having tested an experimental drug within 30 days prior to his inclusion in the study.
- •Patient ( s) with another condition which, according to the investigator , may interfere with the result or conduct of the trial and thus justify their non- inclusion in the study.
研究组 & 干预措施
Physiotherapy
Active Comparator
Traditional techniques
干预措施: Physiotherapy (Procedure)
Physiotherapy
Active Comparator
Traditional techniques
干预措施: Simeox (Device)
simeox
Experimental
Medical device
干预措施: Simeox (Device)
simeox
Experimental
Medical device
干预措施: Physiotherapy (Procedure)
结局指标
主要结局
Safety of the simeox®
时间窗: Day 8
Adverse events related or not to the simeox®
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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