Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
研究概览
简要总结
The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.
Primary objective:
-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.
Secondary objectives:
- To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
- To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.
详细描述
The incidence of bronchiectasis has increased in recent years resulting in greater costs, including periods of hospitalisation and the prescription of drugs.
The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy has been recommended for patients with bronchiectasis and chronic productive cough and/or evidence of mucus plugging on HRCT.
However, to date, there is insufficient evidence of benefits of chest physiotherapy through randomised controlled trials. Furthermore it rests unclear the most effective technique, the frequency and optimum duration of the RP and the most suitable variables to monitor.
A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway clearance will fill this important "gap" in the scientific evidence.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects ≥ 18 years old.
- •Diagnosis of bronchiectasis using a high-resolution computed tomography (HRCT) chest scan performed in the last 2 years.
- •Clinically stable disease (defined as no requirement for antibiotics for exacerbation in the 4 weeks preceding study entry.
- •Chronic sputum expectoration >10ml/24h.
排除标准
- •Bronchiectasis secondary to cystic fibrosis.
- •Inability to perform physiotherapy techniques.
- •Inability to attend the following controls.
- •Treatment with mucolytics, DNase or hypertonic saline during the study.
- •Smokers and ex-smokers ≥ 10 pack/year.
研究组 & 干预措施
Airway clearance, bronchiectasis
The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.
干预措施: Low Expiration Open glottis inferolateral (ELTGOL) (Procedure)
bronchiectasis, stretching
The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary.
干预措施: Stretching (Procedure)
结局指标
主要结局
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
时间窗: 1 year
The primary endpoint for the study is: •Sputum volume during the procedure in the second visit and 24h post treatment which is defined as the volume of mucus expectorated during the physiotherapy procedure and 24h post treatment measured by ml.
次要结局
- Side effects, knowledge(1 year)
研究者
Dr. Montserrat Vendrell Relat
Pneumology Doctor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta