Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

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 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

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