We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01300403
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centro Universitário Augusto Motta
Information provided by:
Universidade Federal do Rio de Janeiro
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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. ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Fernando Silva Guimarães, Augusto Motta University Center
ClinicalTrials.gov Identifier: NCT01300403     History of Changes
Other Study ID Numbers: 02/2009
First Submitted: February 18, 2011
First Posted: February 21, 2011
Last Update Posted: February 21, 2011
Last Verified: September 2010

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases