Airway Clearance Therapy With Simeox Technology in Non-Cystic Fibrosis Bronchiectasis Patients With Chronic Mucus Hypersecretion - A Multicenter Randomized Controlled Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up
研究概览
简要总结
This pilot RCT will assess benefits of Simeox technology on lung function, respiratory symptoms, health-related quality of life, subjective efficiency, device adherence at home, Patient satisfaction, tolerance, safety, and telecare feasibility.
详细描述
Non-cystic fibrosis bronchiectasis (NCFB) is a chronic respiratory disease with multiple etiologies characterized by an irreversible dilatation of bronchi and an impair mucociliary clearance. These alterations cause sticky mucus retention and leads to recurrent infections and chronic bronchial inflammations. Chest physiotherapy is one of the cornerstones of the management of NCFB patients, particularly to facilitate airway clearance. In NCFB patients with chronic mucus hypersecretion (CMH), it is recommended that airway clearance sessions be carried out daily or several times a day, which represents a very significant burden of care. Moreover, access to respiratory physiotherapy for patients can be limited due to several causes: geographical, time or healthcare professional availability constraints. In addition, few healthcare professionals are trained for bronchial drainage especially with airway clearance devices.
SIMEOX® (Physio-Assist, France) is an innovative medical device (CE medical mark) for mucus clearance. The device is connected to patient mouth with an expiratory kit circuit. When the patient starts up the device during exhalation only, SIMEOX® disseminates a vibratory pneumatic signal in the bronchi that liquefies mucus and transports it from distal to central airways for sputum expectoration. After device training with respiratory physiotherapist, patients can be treated at hospital and use SIMEOX® in autonomy at home. Device training and patient follow-up can be performed also remotely with telecare with similar efficiency than face to face visits with health care professionals.
The main objective of this Pilot study is to evaluate the effects of mid-term use of SIMEOX® in autonomy at home for 2 months in NCFB patients with CMH and pulmonary exacerbation (in- or outpatients) in comparison to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with confirmed diagnosis of bronchiectasis confirmed by High Resolution Computed Tomography (HRCT): idiopathic, post-infective, systemic disease, ABPA, asthma, COPD, PCD
- •Overproduction of mucus (ie: estimated bronchorrhea >10mL/day).
- •Pulmonary exacerbation (in- or outpatients)
- •Age > 18 years old
- •Patient able to understand the study and to perform the 2-month follow up visit
排除标准
- •Pneumothorax/pneumo-mediastinum in the six months prior hospitalization
- •Recent episode of severe haemoptysis
- •Unstable severe cardiac disease or hemodynamic instability
- •Cystic fibrosis or COPD as dominant diagnosis
- •Patient on lung transplant list
- •Severe lung injuries
- •Recent lung surgery
- •Inhalation support (continuous ventilatory support)
- •Tracheostomy
- •Uncontrolled GERD
- •Any contraindication to an instrumental bronchial clearance technique (up to the investigator)
- •Inability to perform PFT or 6MWT
- •Patient not available or wishing to move to a different region within 2 months of inclusion
- •Patient considered by the investigator to be physically or mentally inapt to use the device and/or to perform the study procedures.
- •Patient currently participating or having participated within one month prior to inclusion in a clinical intervention research trial that may impact the study, the impact of which is up to the investigator
研究组 & 干预措施
Simeox
Airway clearance device
干预措施: Control (Combination Product)
Control
Usual chest physiotherapy (manual, breathing exercise, PEP/oPEP)
干预措施: Control (Combination Product)
Simeox
Airway clearance device
干预措施: Simeox (Device)
结局指标
主要结局
To describe the evolution in Self-reported home adherence from baseline (hospital discharge) during follow-up
时间窗: 2 months
The evolution of device adherence will be described by % of self-reported sessions (0-1; 2-3; 4-7/week) by the patient over the 2-month FU (1 week, 2 weeks, 1 month and 2 months)
次要结局
- To describe Simeox therapy settings (program selection) during follow-up(2 months)
- To describe Simeox therapy settings (intensity) during follow-up(2 months)
- To describe Simeox therapy settings (number of session) during follow-up(2 months)
- To describe Simeox therapy settings (session duration) during follow-up(2 months)
- To evaluate mucus quality with Simeox therapy during follow-up(2 months)
- To evaluate breathing quality with Simeox therapy during follow-up(2 months)
- To evaluate ease handling of the Simeox device during follow-up(2 months)
- To evaluate pain during Simeox therapy(2 months)
- To evaluate fatigue during Simeox therapy(2 months)
- To evaluate ease of use of Simeox device after 2 months of therapy(2 months)
- To evaluate patient preference between Simeox device and usual care after 2 months of therapy(2 months)
- To evaluate patient recommendation to others patients of Simeox device after 2 months of therapy(2 months)
- Evaluate the feasibility of telecare during follow-up(2 months)
- To evaluate the effect of Simeox on respiratory symptoms in NCFB patients after 2 months of therapy(2 months)
- To evaluate the effect of Simeox on the health-related quality of life of NCFB patients after 2 months of therapy(2 months)
- To evaluate the effect of Simeox on Forced Expiratory Volume at 1 seconde (FEV1) after 2 monts of therapy(2 months)
- To evaluate the effect of Simeox on Forced Vital Capacity (FVC) after 2 monts of therapy(2 months)
- To evaluate the effect of Simeox on Forced Expiratory Flow (FEF) at 25%, 50% and 75% of FVC after 2 monts of therapy(2 months)
- To evaluate the effect of Simeox on dyspnea after 2 monts of therapy(2 months)
- To evaluate the effect of Simeox on exercise capacity after 2 monts of therapy(2 months)
- To evaluate safety of Simeox(2 months)