Study of the Effect of FLUTTER VRP1 in Patients With Bronchiectasis.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Effect of FLUTTER VRP1 on respiratory mucus transport
研究概览
简要总结
The research sought to assess the effects of Flutter ® VRP1 in patients with bronchiectasis.
详细描述
Bronchiectasis is an airway disease with many etiologies characterized pathologically by the abnormal permanent dilatation of bronchi, caused mainly by the perpetuation of inflammatory processes induced by frequent episodes of bacterial infections, with consequent change in the ciliated epithelial lining and compromising the effectiveness of mucociliary clearance that can favor the hypersecretive state found in these patients.
In addition to drug therapy or surgical treatment, patients with bronchiectasis also have physiotherapy, which is an important part in treatment. The patients present impaired mucus transport, and can enjoy the benefits provided by respiratory therapy, which features intended to increase the removal of airway secretions and thus reduce the obstruction to improve ventilation and oxygenation.
One of the instruments commonly used in respiratory therapy is the Flutter ® VRP1 (VarioRaw SA, Switzerland), which is a simple equipment, small, similar to a pipe that combines two techniques: positive expiratory pressure (PEP) and high-frequency oscillations.
Some previous studies have shown beneficial effects after use of this device in patients with bronchiectasis. However, it is unclear whether the mechanism of action is related to the combination of PEP and the techniques of high frequency oscillation, or just one of those components.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non Cystic Fibrosis Bronchiectasis
- •Amount of secretion sufficient for analysis
- •Capable of fulfilling the experimental protocol
排除标准
- •Acute pulmonary disease
- •Presence of any respiratory infection in the last four weeks
研究组 & 干预措施
Flutter group
In Flutter group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland).
干预措施: Flutter group (Other)
PEP group
In PEP group the exercise used the Flutter ®VRP1 (VarioRaw SA, Switzerland) without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1.
干预措施: PEP group (Other)
control group
In placebo patients were assessed as pulmonary function, respiratory muscle strength and transport properties of respiratory secretions
干预措施: control group (Other)
Group Sham
Exercise with Flutter®VRP1 without the ball inside
干预措施: Group Sham (Other)
结局指标
主要结局
The Effect of FLUTTER VRP1 on respiratory mucus transport
时间窗: five years
30 patients with bronchiectasis will receive sessions with the Flutter®VRP1 or PEP for 30 minutes daily in a randomized, crossover study. Weekly secretion samples will be collected and evaluated for mucociliary relative transport velocity(RTV), displacement in a simulated cough machine(SCM) and contact angle measurement(CAM).
次要结局
未报告次要终点
研究者
Ada Clarice Gastaldi
Professor Ada Clarice Gastaldi
University of Sao Paulo