Brief Title
Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients
Official Title
Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients
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.
Study Type
Interventional
Primary Outcome
Expectorated sputum volume.
Secondary Outcome
Respiratory mechanics (spectral data recorded by impulse oscillation technique).
Condition
Bronchiectasis
Intervention
Flutter Valve
Study Arms / Comparison Groups
Flutter Valve
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
8
Start Date
September 2004
Completion Date
June 2006
Primary Completion Date
November 2005
Eligibility Criteria
Inclusion Criteria: - patients with clinical and high-resolution computerized tomography diagnosis. Exclusion Criteria: - 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
Gender
All
Ages
28 Years - 92 Years
Accepts Healthy Volunteers
No
Contacts
Fernando S Guimarães, PhD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT00656721
Organization ID
002434-UFRJ
Responsible Party
Principal Investigator
Study Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study Sponsor
Fernando S Guimarães, PhD, Study Chair, Universidade Federal do Rio de Janeiro
Verification Date
June 2015