Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

Bronchiectasis Clinical Trial

Official title:

Flutter Valve Improves Respiratory Mechanics and Sputum Production in Bronchiectasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656721
• Other study ID #: 002434-UFRJ
• Status: Completed
• Phase: N/A
• First received: April 7, 2008
• Last updated: June 18, 2015
• Start date: September 2004
• Est. completion date: June 2006

Study information

• Verified date: June 2015
• Source: Universidade Federal do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Years to 92 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Clementino Fraga Filho	Rio de Janeiro
Brazil	Universidade Federal do Rio de Janeiro	Rio de Janeiro

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Federal do Rio de Janeiro	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Financiadora de Estudos e Projetos, Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expectorated sputum volume.		After each evaluated procedure (control and Flutter Valve intervention)	No
Secondary	Respiratory mechanics (spectral data recorded by impulse oscillation technique).		Before and after each applied procedure (control and Flutter Valve intervention)	No