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Completed

NCT Number: NCT00656721

Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

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.

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Key information

Age range

28 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flutter Valve

Device

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 names: FLUTTER® Mucus Clearance Device

Primary outcomes

  1. Expectorated sputum volume.

    Time frame: After each evaluated procedure (control and Flutter Valve intervention)

Secondary outcomes

  1. Respiratory mechanics (spectral data recorded by impulse oscillation technique).

    Time frame: Before and after each applied procedure (control and Flutter Valve intervention)

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Financiadora de Estudos e Projetos
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients

Important dates

Study start
2004
Primary completion
2005
Study completion
2006
First posted
Apr 11, 2008
Registry last updated
Jun 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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