"A Prospective, Cross-over Randomized Trial to Assess the Efficacy and Safety of Mechanical Percussor "LEGA" Compared With Conventional Chest Physiotherapy in Adults With Chronic Bronchiectasis or Chronic Obstructive Pulmonary Disease (COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.
研究概览
简要总结
A Malaysian company by name Formedic Technologies SDN BHD has devised a hand held machine which is supposed to mimic the chest percussion performed by professional physiotherapist to mobilize sputum through the respiratory passage.
The aim of this study is to compare the effectiveness and safety of this mechanical percussion device in the treatment of airway clearance with conventional chest physiotherapy carried out by qualified physiotherapists in patients suffering from bronchiectasis or Chronic obstructive Pulmonary disease (COPD).
详细描述
This study will compare the amount of sputum expectorated during the two procedures and not intended to look at the clinical improvement of the patient.
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
- •Adult patients > 18 years of age
- •Chronic sputum expectoration-(producing >30ml/day of sputum at baseline)
- •Clinical diagnosis of bronchiectasis or COPD
- •Not carrying out regular chest physiotherapy (for the purposes of this study this will be defined as less than two occasions per week)
- •Clinically stable disease (defined as no requirement for antibiotics in the 4 weeks preceding study entry).
- •FEV1 of > 35% of the predicted value in COPD patients
排除标准
- •Primary diagnosis of asthma;
- •Active sarcoidosis
- •Active Pulmonary tuberculosis.
- •History of brittle bones,
- •History of broken ribs in the past one year.
- •History of severe osteoporosis
- •Bleeding from the lungs or haemoptysis
- •Experiencing intense pain in the thoracic region
- •Clinical suspicion of increased intracranial pressure.
- •Have head or neck injuries
- •Have collapsed lungs or a damaged chest wall;
- •Recent myocardial infarction, unstable angina and stroke (Within 6 months prior to enrollment)
- •Have a pulmonary embolism or lung abscess;
- •Have an active hemorrhage
- •Have injuries to the spine
- •Have open wounds or burns in the thoracic region
- •Have had recent surgery (Within six months prior to enrollment.)
- •Any systemic steroids within 4/52 prior to enrollment
- •Any antibiotics within 4/52 prior to enrollment
结局指标
主要结局
Comparing the 'wet weight' and 'dry weight' of the sputum expectorated during 20 minutes of the two procedures.
时间窗: 6 days
The patients will be instructed to cough out the sputum into a preweighed container during the 15 minutes of the procedure(Manual or mechanical percussion)and 5 minutes after the procedure.Container will be weighed to get the wet weight of the sputum then will be dried in a laboratory oven at 60degree c for 48 hours and weighed again to get the dry weight of the sputum
次要结局
- Change in FEV1 and FVC before and after the two methods of therapy(15 minutes after completion of the procedure compared to baseline)
- Changes in pulse, blood pressure and respiratory rate(15 minutes after completion of treatment compared to baseline)
- Patient preference(After completing 6 days of participation in the study)
研究者
Dr.Ong Loke Meng
Head, Clinical Research Centre
Penang Hospital, Malaysia