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临床试验/NCT00656721
NCT00656721已完成不适用

Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Expectorated sputum volume.

研究概览

简要总结

Considering that respiratory physiotherapy lack scientific evidence to support its application in the treatment of several obstructive diseases, this investigation was designed to evaluate the hypothesis that Flutter Valve can improve the airway clearance of hypersecretive bronchiectasis patients.

详细描述

The application of airway clearance techniques is considered an important component in the treatment of bronchiectasis patients (Van der Shans, 1997). For this purpose, a number of techniques has been introduced in the last decades. The Flutter Valve was initially proposed for the treatment of children with cystic fibrosis (CF) (Lindemann, 1992), but there is not enough evidence about its utilization in patients with bronchiectasis (Van der Shans & cols, 1999).

The effects of the Flutter Valve on respiratory mechanics of patients with bronchiectasis have been evaluated by forced spirometry (Pryor e cols, 1994; Gondor e cols, 1999; Thompson e cols, 2002). This approach however, does not allow the characterization of mucus transportation along the airways (Williams, 1994). The forced oscillation technique (FOT), a non-invasive alternative to characterize respiratory mechanics, allows the evaluation of respiratory mechanics at different frequencies without special maneuvers (Dubois e cols., 1956). According to eligibility criteria and in a randomized order, the patients were submitted to two protocols (control and Flutter Valve intervention), with one-week interval between them (washout). Respiratory mechanics and expectorated sputum volume were assessed before and after each intervention, in order to assess the Flutter Valve effect on tracheobronchial sputum removal.

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
Single (Outcomes Assessor)

入排标准

年龄范围
28 Years 至 92 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with clinical and high-resolution computerized tomography diagnosis.

排除标准

  • •chest pain,
  • •acute hemoptysis,
  • •recent history of rib fracture or pneumothorax (less than 1 year),
  • •respiratory infection in the four weeks before measurements,
  • •cystic fibrosis,
  • •daily sputum production lower than 25 mL/day

研究组 & 干预措施

Flutter Valve

Experimental

This a crossover study, so all subjects performed both, control and experimental interventions. In Flutter Valve intervention the subjects remained comfortably seated, breathing through the device for 15 minutes, starting off from the total pulmonary capacity, and being free to cough. Thereafter, a 5-min session of cough ensued. In the control intervention the subjects followed the same sequence of the Flutter Valve intervention, but the metallic sphere and the cover of the device were removed. Since the patients were not acquainted with the valve, they did not know its proper assembly. As in the Flutter Valve intervention, during 15 minutes the patients could expectorate spontaneously and return to the device. A 5-min coughing session took place.

干预措施: Flutter Valve (Device)

结局指标

主要结局

Expectorated sputum volume.

时间窗: After each evaluated procedure (control and Flutter Valve intervention)

次要结局

  • Respiratory mechanics (spectral data recorded by impulse oscillation technique).(Before and after each applied procedure (control and Flutter Valve intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Silva Guimaraes

Associate Professor

Universidade Federal do Rio de Janeiro

研究点 (2)

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