Clinical trial NCT00656721: Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients
Official title: Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: bronchiectasis
physiotherapy
flutter valve
impulse oscillation technique
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Financiadora de Estudos e Projetos
First posted: 2008-04-11
Enrollment: 8
Sex: ALL
Minimum age (years): 28
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Expectorated sputum volume.
timeFrame: After each evaluated procedure (control and Flutter Valve intervention)
Secondary outcomes:
measure: Respiratory mechanics (spectral data recorded by impulse oscillation technique).
timeFrame: Before and after each applied procedure (control and Flutter Valve intervention)
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Fernando S Guimarães, PhD
role: STUDY_CHAIR
References: