BronchiectasisNCT01300403
Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis
A study testing Flutter valve and expiration with the glottis open in lateral posture (ELTGOL) in people with Bronchiectasis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Flutter valve and expiration with the glottis open in lateral posture (ELTGOL)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with clinical and radiological criteria of bronchiectasis
Who cannot join
- heart failure
- pneumonia
- chest pain
- inability to perform the procedures
- asthma
- cystic fibrosis
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Pedro Ernesto
Rio de Janeiro, Rio de Janeiro, 20550-170
About this study
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
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.
- Conditions
- Bronchiectasis
- Being tested
- Flutter valve, expiration with the glottis open in lateral posture (ELTGOL), Control
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flutter valveOther
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.
expiration with the glottis open in lateral posture (ELTGOL)Other
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.
ControlOther
Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.
| Study group | Role | What they receive |
|---|---|---|
| FLUTTER | Experimental | Since this was a crossover study, all patients performed all interventions in a randomized order. Receives: Other: Flutter valve |
| ELTGOL | Experimental | Since this was a crossover study, all patients performed all interventions in a randomized order. Receives: Other: expiration with the glottis open in lateral posture (ELTGOL) |
| CONTROL | Active comparator | Since this was a crossover study, all patients performed all interventions in a randomized order. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic and static lung volumes
Dynamic and static lung volumes were assessed by forced spirometry and plethysmography.
Measured: In the week 1, 2 and 3. Before (baseline) and after each intervention.
Secondary outcomes (1)
Sputum production
The expectorated secretions were collected using a sputum trap and quantificated by its dry weight.
Measured: Sputum was colected during the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitário Augusto Motta
- Investigators
- Fernando S Guimarães, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300403
- Sponsor's protocol ID
- 02/2009
- Status last verified
- Sep 2010
- First submitted
- 18 Feb 2011
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01300403
- Acronym / sponsor ID
- 02/2009
- Conditions
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Centro Universitário Augusto Motta
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FLUTTER | Experimental | Other: Flutter valveSince this was a crossover study, all patients performed all interventions in a randomized order. |
| ELTGOL | Experimental | Other: expiration with the glottis open in lateral posture (ELTGOL)Since this was a crossover study, all patients performed all interventions in a randomized order. |
| CONTROL | Active comparator | Other: ControlSince this was a crossover study, all patients performed all interventions in a randomized order. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with clinical and radiological criteria of bronchiectasis
Key exclusion criteria (6 listed)
- heart failure
- pneumonia
- chest pain
- inability to perform the procedures
- asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flutter valveFlutter 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. | Other | FLUTTER |
| 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. | Other | ELTGOL |
| ControlPatients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period. | Other | CONTROL |
Primary outcome
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.
1 secondary outcome
Sputum production
Time frame: Sputum was colected during the interventions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando S Guimarães, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flutter valve and expiration with the glottis open in lateral posture (ELTGOL) in people with Bronchiectasis, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic and static lung volumes (time frame: In the week 1, 2 and 3. Before (baseline) and after each intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2011.