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Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Flutter Valve
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring bronchiectasis, physiotherapy, flutter valve, impulse oscillation technique

Eligibility Criteria

28 Years - 92 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidade Federal do Rio de Janeiro
  • Hospital Universitário Clementino Fraga Filho

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flutter Valve

Arm 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.

Outcomes

Primary Outcome Measures

Expectorated sputum volume.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2008
Last Updated
June 18, 2015
Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Financiadora de Estudos e Projetos
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1. Study Identification

Unique Protocol Identification Number
NCT00656721
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Rio de Janeiro State Research Supporting Foundation (FAPERJ), Financiadora de Estudos e Projetos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
bronchiectasis, physiotherapy, flutter valve, impulse oscillation technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flutter Valve
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Flutter Valve
Other Intervention Name(s)
FLUTTER® Mucus Clearance Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expectorated sputum volume.
Time Frame
After each evaluated procedure (control and Flutter Valve intervention)
Secondary Outcome Measure Information:
Title
Respiratory mechanics (spectral data recorded by impulse oscillation technique).
Time Frame
Before and after each applied procedure (control and Flutter Valve intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Years
Maximum Age & Unit of Time
92 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando S Guimarães, PhD
Organizational Affiliation
Universidade Federal do Rio de Janeiro
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro
City
Rio de Janeiro
ZIP/Postal Code
21941-902
Country
Brazil
Facility Name
Hospital Universitário Clementino Fraga Filho
City
Rio de Janeiro
ZIP/Postal Code
21949-900
Country
Brazil

12. IPD Sharing Statement

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Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients

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