Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis
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
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2009
1 active site
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
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 18, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedFebruary 21, 2011
September 1, 2010
1.2 years
February 18, 2011
February 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Dynamic and static lung volumes
Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.
In the week 1, 2 and 3. Before (baseline) and after each intervention.
Secondary Outcomes (1)
Sputum production
Sputum was colected during the interventions
Study Arms (3)
FLUTTER
EXPERIMENTALSince this was a crossover study, all patients performed all interventions in a randomized order.
ELTGOL
EXPERIMENTALSince this was a crossover study, all patients performed all interventions in a randomized order.
CONTROL
ACTIVE COMPARATORSince this was a crossover study, all patients performed all interventions in a randomized order.
Interventions
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.
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.
Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.
Eligibility Criteria
You may qualify if:
- Patients with clinical and radiological criteria of bronchiectasis
You may not qualify if:
- heart failure
- pneumonia
- chest pain
- inability to perform the procedures
- asthma
- cystic fibrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20550-170, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando S Guimarães, PhD
Universidade Federal do Rio de Janeiro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2011
First Posted
February 21, 2011
Study Start
June 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 21, 2011
Record last verified: 2010-09