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Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis

Primary Purpose

Bronchiectasis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Flutter valve

expiration with the glottis open in lateral posture (ELTGOL)

Control

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with clinical and radiological criteria of bronchiectasis

Exclusion Criteria:

heart failure
pneumonia
chest pain
inability to perform the procedures
asthma
cystic fibrosis

Sites / Locations

Hospital Universitário Pedro Ernesto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

FLUTTER

ELTGOL

CONTROL

Arm Description

Since this was a crossover study, all patients performed all interventions in a randomized order.

Outcomes

Primary Outcome Measures

Dynamic and static lung volumes

Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.

Secondary Outcome Measures

Sputum production

The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.

Full Information

NCT ID

NCT01300403

First Posted

February 18, 2011

Last Updated

February 18, 2011

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Centro Universitário Augusto Motta

1. Study Identification

Unique Protocol Identification Number

NCT01300403

Brief Title

Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis

Official Title

Acute Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Dynamic and Static Pulmonary Volumes of Patients With Bronchiectasis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Centro Universitário Augusto Motta

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study aimed to evaluate the acute physiological effects of expiration with the glottis open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in patients with bronchiectasis and, secondarily, to study the effect of these techniques in sputum production.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiectasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLUTTER

Arm Type

Experimental

Arm Description

Since this was a crossover study, all patients performed all interventions in a randomized order.

Arm Title

ELTGOL

Arm Type

Experimental

Arm Description

Since this was a crossover study, all patients performed all interventions in a randomized order.

Arm Title

CONTROL

Arm Type

Active Comparator

Arm Description

Since this was a crossover study, all patients performed all interventions in a randomized order.

Intervention Type

Other

Intervention Name(s)

Flutter valve

Intervention Description

Flutter valve is a physiotherapy device commonly used for the treatment of pulmonary hypersecretive conditions. The patients is taught to exhale through the device, producing positive expiratory pressure and flow oscillations. In this study the intervention took 15 minutes. During this period the patients were free to cough.

Intervention Type

Other

Intervention Name(s)

expiration with the glottis open in lateral posture (ELTGOL)

Intervention Description

This technique is a maneuver of slow expiration with the glottis open, with the subject in lateral posture. The patients performed three sets of 10 repetitions in left and right lateral decubitus.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.

Primary Outcome Measure Information:

Title

Dynamic and static lung volumes

Description

Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.

Time Frame

In the week 1, 2 and 3. Before (baseline) and after each intervention.

Secondary Outcome Measure Information:

Title

Sputum production

Description

The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.

Time Frame

Sputum was colected during the interventions

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with clinical and radiological criteria of bronchiectasis Exclusion Criteria: heart failure pneumonia chest pain inability to perform the procedures asthma cystic fibrosis

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

Principal Investigator

Facility Information:

Facility Name

Hospital Universitário Pedro Ernesto

City

Rio de Janeiro

ZIP/Postal Code

20550-170

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis

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