- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300403
Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis
February 18, 2011 updated by: Universidade Federal do Rio de Janeiro
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio de Janeiro, Brazil, 20550-170
- Hospital Universitário Pedro Ernesto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: FLUTTER
Since this was a crossover study, all patients performed all interventions in a randomized order.
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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.
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Experimental: ELTGOL
Since this was a crossover study, all patients performed all interventions in a randomized order.
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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.
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Active Comparator: CONTROL
Since this was a crossover study, all patients performed all interventions in a randomized order.
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Patients were instructed to stay comfortably seated during 15 minutes.
After this period they were stimulated to cough during a five minutes period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic and static lung volumes
Time Frame: In the week 1, 2 and 3. Before (baseline) and after each intervention.
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Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.
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In the week 1, 2 and 3. Before (baseline) and after each intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sputum production
Time Frame: Sputum was colected during the interventions
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The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.
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Sputum was colected during the interventions
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Fernando S Guimarães, PhD, Universidade Federal do Rio de Janeiro
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
February 18, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (Estimate)
February 21, 2011
Study Record Updates
Last Update Posted (Estimate)
February 21, 2011
Last Update Submitted That Met QC Criteria
February 18, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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