NCT00656721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
Last Updated

June 22, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

April 7, 2008

Last Update Submit

June 18, 2015

Conditions

Bronchiectasis

Keywords

bronchiectasisphysiotherapyflutter valveimpulse oscillation technique

Outcome Measures

Primary Outcomes (1)

  • Expectorated sputum volume.

    After each evaluated procedure (control and Flutter Valve intervention)

Secondary Outcomes (1)

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

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

Study Arms (1)

Flutter Valve

EXPERIMENTAL

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

Interventions

Flutter ValveDEVICE

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.

Also known as: FLUTTER® Mucus Clearance Device
Flutter Valve

Eligibility Criteria

Age28 Years - 92 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with clinical and high-resolution computerized tomography diagnosis.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 21941-902, Brazil

Location

Hospital Universitário Clementino Fraga Filho

Rio de Janeiro, Rio de Janeiro, 21949-900, Brazil

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Study Officials

  • Fernando S Guimarães, PhD

    Universidade Federal do Rio de Janeiro

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

September 1, 2004

Primary Completion

November 1, 2005

Study Completion

June 1, 2006

Last Updated

June 22, 2015

Record last verified: 2015-06

Locations

BR(2)