Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

This study has been completed.
Sponsor:
Collaborators:
Centers of Excellence Program (PRONEX-MCT),
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Financing for Studies and Projects (FINEP),
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00656721
First received: April 7, 2008
Last updated: November 6, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Bronchiectasis
Device: Flutter Valve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Expectorated sputum volume. [ Time Frame: After each evaluated procedure (control and Flutter Valve intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Respiratory mechanics (spectral data recorded by impulse oscillation technique). [ Time Frame: Before and after each applied procedure (control and Flutter Valve intervention) ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: September 2004
Study Completion Date: June 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Flutter Valve

Flutter Valve (Scandipharm, Birmingham, AL) is shaped like a pipe with a hardened plastic mouthpiece at one end, a plastic protective, perforated cover at the other end, and a high-density stainless steel ball resting in a plastic circular cone on the inside. When the patient expires, a vibratory effect is transmitted to airways by the steel ball oscillation in order to facilitate mucociliary clearance.

In our study, the use of the equipment was guided by a registered physical therapist, but the position (angle) was determined by the patient, according to his/her adaptation and perception of effectiveness of sputum clearance. The patients remained comfortably seated, breathing through the device for 15 minutes, starting from the total pulmonary capacity, and being free to cough. Thereafter, a 5-minute session of cough was done.

Other Name: FLUTTER® Mucus Clearance Device

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.

  Eligibility

Ages Eligible for Study:   28 Years to 92 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00656721

Locations
Brazil
Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, Brazil, 21949-900
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 21941-902
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Centers of Excellence Program (PRONEX-MCT),
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Financing for Studies and Projects (FINEP),
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Study Chair: Fernando S Guimarães, PhD Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Fernando Silva Guimarães, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00656721     History of Changes
Other Study ID Numbers: 002434-UFRJ
Study First Received: April 7, 2008
Last Updated: November 6, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
bronchiectasis
physiotherapy
flutter valve
impulse oscillation technique

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014