NCT06820918进行中（未招募）不适用
Impact of Physiotherapy With Positive Expiratory Pressure (PEP) Bottle on Respiratory Function in Patients With Bronchiectasis (FisioFEV)
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second)
研究概览
简要总结
The aim of this study is to determine whether respiratory physiotherapy using the Positive Expiratory Pressure (PEP) bottle has an effect on respiratory function, measured through spirometry, in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Subject over 18 years of age
- •Confirmed diagnosis of bronchiectasis based on high-resolution chest CT, showing bronchial dilation according to one or more of the following radiological criteria in accordance with the 2019 BTS guidelines.
- •Ratio between the internal lumen of the bronchus and the adjacent pulmonary artery >1
- •Absence of normal bronchial tapering
- •Visibility of the airways within 1 cm from the pleura
- •Subject with chronic bronchial hypersecretion (daily secretion ≥ 15ml)
- •Patients capable of performing physiotherapy using the PEP bottle
- •Patients capable of performing global spirometry
排除标准
- •Subject already undergoing regular respiratory physiotherapy
- •Subject without significant bronchial hypersecretion
- •Concomitant diagnosis of Cystic Fibrosis, Primary Ciliary Dyskinesia, NTM-PD, TB, Sarcoidosis, Active Neoplasia
- •Diagnosis of Asthma according to the 2023 GINA guidelines, defined as documented excessive variability in pulmonary function (positive bronchodilation or bronchoprovocation test with methacholine, or diurnal variability of PEF) + documented limitation of expiratory airflow.
- •Diagnosis of COPD according to the 2023 GOLD guidelines, defined as FEV/FVC post-bronchodilation <0.7 on forced spirometry in the presence of suggestive symptoms (dyspnea, chronic cough, sputum production) and/or exposure to risk factors for the disease (e.g., cigarette smoking).
- •Contraindications to PEP-Bottle Physiotherapy (Pneumothorax; Hemoptysis; Myocardial infarction in the 4 weeks prior to informed consent signature)
- •Exacerbation of disease in the previous 4 weeks
- •Use of inhalation therapy in the 4 weeks prior to informed consent signature
- •Active smoker
- •Subject undergoing non-invasive ventilation or with a tracheostomy
- •Inability to provide informed consent
研究组 & 干预措施
Patients with bronchiectasis
Experimental
干预措施: Bottle PEP (Device)
结局指标
主要结局
To evaluate the effect of respiratory physiotherapy using a PEP bottle on respiratory function through the measurement of FEV1 (Forced Expiratory Volume in the 1st second)
时间窗: 60 days
To evaluate the effect of respiratory physiotherapy using the PEP bottle on respiratory function in patients with a diagnosis of bronchiectasis not associated with cystic fibrosis.
次要结局
未报告次要终点
研究者
RICHELDI LUCA
Prof.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
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