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

This study has been completed.
Sponsor:
Collaborator:
Centro Universitário Augusto Motta
Information provided by:
Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01300403
First received: February 18, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Bronchiectasis
Other: Flutter valve
Other: expiration with the glottis open in lateral posture (ELTGOL)
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Dynamic and static lung volumes [ Time Frame: In the week 1, 2 and 3. Before (baseline) and after each intervention. ] [ Designated as safety issue: No ]
    Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.


Secondary Outcome Measures:
  • Sputum production [ Time Frame: Sputum was colected during the interventions ] [ Designated as safety issue: No ]
    The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.


Enrollment: 10
Study Start Date: June 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FLUTTER
Since this was a crossover study, all patients performed all interventions in a randomized order.
Other: Flutter valve
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.
Experimental: ELTGOL
Since this was a crossover study, all patients performed all interventions in a randomized order.
Other: expiration with the glottis open in lateral posture (ELTGOL)
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.
Active Comparator: CONTROL
Since this was a crossover study, all patients performed all interventions in a randomized order.
Other: Control
Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300403

Locations
Brazil
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Brazil, 20550-170
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Centro Universitário Augusto Motta
Investigators
Principal Investigator: Fernando S Guimarães, PhD Universidade Federal do Rio de Janeiro
  More Information

No publications provided

Responsible Party: Fernando Silva Guimarães, Augusto Motta University Center
ClinicalTrials.gov Identifier: NCT01300403     History of Changes
Other Study ID Numbers: 02/2009
Study First Received: February 18, 2011
Last Updated: February 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014