NCT04010253已完成不适用
Impact of Bronchial Drainage by the Medical Device Simeox® on Function and Respiratory Symptoms Compared to Manual Autogenous Drainage Physiotherapy in Adult Cystic Fibrosis Patients
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche8 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2019年9月30日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Low frequency resistance R5
研究概览
简要总结
The main objective of the study is to evaluate the short-term effects of the airway clearance technique by the medical device Simeox (Physio Assist, France) versus Autogenic Drainage, on the pulmonary function of adult patients with stable cystic fibrosis. To analyse these effects, the investigators used forced oscillation technique measured by TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) with an evaluation of the perceived clinical benefits.
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
- 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
- •Diagnosis of cystic fibrosis confirmed
- •Age ≥18 years
- •30% <FEV1 <70% predicted
- •Presence of bronchial congestion reported by the patient or the investigator
排除标准
- •Uncontrolled asthma
- •Pneumothorax <6 weeks
- •Recent severe hemoptysis <6 weeks
- •Patient registered on the transplant list
- •Exacerbation within 4 weeks (3 months if hospitalization) before screening
- •Cardiovascular disorders, electrocardiogram (ECG) parameters or clinically significant respiratory (non-cystic fibrosis) conditions
- •Patients unable to perform measurements of ROF, spirometry, plethysmography.
- •Any contraindication to manual or instrumental physiotherapy.
- •Pregnancy, breastfeeding.
- •Patient under tutorship or curatorship
- •No affiliation to the French social security
- •Patient using Simeox at home
- •Patient under Trikafta for less than 6 weeks.
- •Patient using Simeox more than twice a week during physiotherapy sessions, not wanting a washout period of 7 days before inclusion
研究组 & 干预措施
SIMEOX
Experimental
干预措施: Autogenic drainage (Other)
Autogenic Drainage
Active Comparator
干预措施: SIMEOX (Device)
结局指标
主要结局
Low frequency resistance R5
时间窗: 1 month
Comparison of variations V4 and V8 sessions (pre and post airway clearance session)
次要结局
- Evaluation of the distal and / or proximal decluttering by the two techniques, according to the improvement profile of the forced oscillations(1 month)
- Evaluation of correlations between clinical benefit and changes in functional respiratory investigations (forced oscillations, spirometry, plethysmography)(1 month)
- Comparison of the impact of Simeox® bronchial drainage compared to autogenous drainage on respiratory symptoms: dyspnea, congestion and fatigue(1 month)
- Evaluation of the impact of Simeox® bronchial drainage vs autogenous drainage by spirometry and plethysmography (distension and resistance)(1 month)
研究者
研究点 (8)
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