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2019年9月30日

适应症Cystic Fibrosis

干预措施Autogenic drainage SIMEOX

概览

阶段: 不适用
干预措施: Autogenic drainage
疾病 / 适应症: Cystic Fibrosis
发起方: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
入组人数: 31
试验地点: 8
主要终点: Low frequency resistance R5
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2019年9月30日

结束日期

2023年12月13日

最后更新

上个月

研究类型

Interventional

研究设计

Crossover

性别

All

研究者

发起方

Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

责任方

Sponsor

入排标准

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

研究组 & 干预措施

SIMEOX

干预措施: Autogenic drainage

Autogenic Drainage

干预措施: SIMEOX

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)