Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients
- Conditions
- Bronchiectasis
- Interventions
- Device: Flutter Valve
- Registration Number
- NCT00656721
- Lead Sponsor
- Universidade Federal do Rio de Janeiro
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- patients with clinical and high-resolution computerized tomography diagnosis.
- chest pain,
- acute hemoptysis,
- recent history of rib fracture or pneumothorax (less than 1 year),
- respiratory infection in the four weeks before measurements,
- asthma,
- cystic fibrosis,
- daily sputum production lower than 25 mL/day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Flutter Valve Flutter Valve 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.
- Primary Outcome Measures
Name Time Method Expectorated sputum volume. After each evaluated procedure (control and Flutter Valve intervention)
- Secondary Outcome Measures
Name Time Method Respiratory mechanics (spectral data recorded by impulse oscillation technique). Before and after each applied procedure (control and Flutter Valve intervention)
Trial Locations
- Locations (2)
Universidade Federal do Rio de Janeiro
🇧🇷Rio de Janeiro, Brazil
Hospital Universitário Clementino Fraga Filho
🇧🇷Rio de Janeiro, Brazil