Cystic FibrosisNCT02600039
The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients
A study testing ELTGOL and Acapella in people with Cystic Fibrosis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- ELTGOL and Acapella
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2015to Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria: Volunteers with Cystic Fibrosis and lung disease with chest hemiperímetro ≥ 37 cm. Exclusion Criteria: Episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Pernambuco
Amanda S Couto, Msc, +5586999217512, sc_amanda@hotmail.com
About this study
Official title: The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients: Randomized Crossover Study
Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.
- Conditions
- Cystic Fibrosis
- Being tested
- ELTGOL, Acapella
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELTGOLOther
Individuals will be placed in the lateral decubitus position and instructed to perform slow expirations with an open glottis through a nozzle attached to the mouth from the residual functional capacity to residual volume. Concurrently, a trained and subsequently positioned relative to the voluntary physical therapist will perform a manual compression of the abdominal region dependent and the rib cage to enhance contralateral lung deflation. This intervention is performed so that the time is homogeneous between each repetition interval of one minute between each set. To this end, three sets of ten repetitions will be performed on each lateral decubitus (left and right)
AcapellaDevice
Participant should be comfortably seated and with his elbows on a table. The mouthpiece is attached properly to not allow leaks. The resistance load will be one in which the individual is able to maintain uninterrupted expiration of 3 seconds. Then the patient will be instructed to inhale slowly and deeply, with lung volumes between the residual volume and total lung capacity. The air exhaled by Acapella is directed toward an orifice which opens and closes periodically, promoting oscillations in the air stream throughout the expiratory phase. The expiration is always performed to the VR, and without performing the active contraction of the abdominal muscles. Still prompted an inspiratory pause of 2 seconds for the end of the inspiratory phase. This procedure will be performed in 4 sets of 5 minutes with interval of 1 minute between the series.
| Study group | Role | What they receive |
|---|---|---|
| ELTGOL | Experimental | Not described Receives: Other: ELTGOL; Device: Acapella |
| Acapella | Active comparator | Not described Receives: Other: ELTGOL; Device: Acapella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Electrical Impedance on the End-Expiration
Measured: up to 30 minutes
Secondary outcomes (4)
Dyspnea assessed by the Borg scale
Measured: baseline, one minute and thirtieth minutes
Oxygen saturation assessed by oximeter
Measured: baseline, one minute and thirtieth minutes
Preferred technique assessed by an open question
Measured: up to 3 minutes
Adverse Effects associeted with ELTGOL and Acapella assessed by an open question
Measured: baseline, one minute and thirtieth minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Silva Couto, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600039
- Sponsor's protocol ID
- 37906314.3.0000.5208
- Status last verified
- Nov 2015
- First submitted
- 29 Oct 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients: Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT02600039
- Acronym / sponsor ID
- 37906314.3.0000.5208
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 9 Nov 2015 (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.
Cystic Fibrosis (CF) is the most common lethal autosomal recessive disease. Respiratory therapy is always recommended to the CF patient with pulmonary involvement and has differents techniques and devices, however, there is no consensus on the effectiveness of the techniques used, there is a need to determine the applicability of the therapeutic resources used. Therefore, the aim of the study is to determine the short-term effectiveness of ELTGOL on Average Electrical Impedance on the End of Expiration (MIEFE) pulmonary, assessed by Electrical Impedance Tomography (EIT) in individuals with CF through a clinical trial randomized crossover. Volunteers will be included with FC with moderate to severe lung disease with chest ≥ 74 cm that do not show: episode of pulmonary infectious exacerbations in the last four weeks or during the study period; cor pulmonale; facial deformity that causes air leakage; facial trauma and recent face or esophagus surgery; chest pain; hemoptysis in the last week; continued use of supplemental oxygen (> 8 hours / day); hemoptysis; hemodynamic instability and do not understand the use and command of the techniques used. The sample is selected by convenience from the database of individuals assisted data in Integrative Medicine Institute Professor Fernando Figueira (IMIP). The research will be developed in three phases, divided into three days with an interval of at least 48 hours between phases. The first day will undergo initial assessment and in the days following the intervention by day, ELTGOL or Acapella, in a randomized order.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELTGOL | Experimental | Other: ELTGOL, Device: Acapella |
| Acapella | Active comparator | Other: ELTGOL, Device: Acapella |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| ELTGOLIndividuals will be placed in the lateral decubitus position and instructed to perform slow expirations with an open glottis through a nozzle attached to the mouth from the residual functional capacity to residual volume. Concurrently, a trained and subsequently positioned relative to the voluntary physical therapist will perform a manual compression of the abdominal region dependent and the rib cage to enhance contralateral lung deflation. This intervention is performed so that the time is homogeneous between each repetition interval of one minute between each set. To this end, three sets of ten repetitions will be performed on each lateral decubitus (left and right) | Other | Acapella, ELTGOL |
| AcapellaParticipant should be comfortably seated and with his elbows on a table. The mouthpiece is attached properly to not allow leaks. The resistance load will be one in which the individual is able to maintain uninterrupted expiration of 3 seconds. Then the patient will be instructed to inhale slowly and deeply, with lung volumes between the residual volume and total lung capacity. The air exhaled by Acapella is directed toward an orifice which opens and closes periodically, promoting oscillations in the air stream throughout the expiratory phase. The expiration is always performed to the VR, and without performing the active contraction of the abdominal muscles. Still prompted an inspiratory pause of 2 seconds for the end of the inspiratory phase. This procedure will be performed in 4 sets of 5 minutes with interval of 1 minute between the series. | Device | Acapella, ELTGOL |
Primary outcome
Average Electrical Impedance on the End-Expiration
Time frame: up to 30 minutes
4 secondary outcomes
Dyspnea assessed by the Borg scale
Time frame: baseline, one minute and thirtieth minutes
Oxygen saturation assessed by oximeter
Time frame: baseline, one minute and thirtieth minutes
Preferred technique assessed by an open question
Time frame: up to 3 minutes
Adverse Effects associeted with ELTGOL and Acapella assessed by an open question
Time frame: baseline, one minute and thirtieth minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
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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.
Instituto de Medicina Integral Professor Fernando Figueira
Recife, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELTGOL and Acapella in people with Cystic Fibrosis, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Electrical Impedance on the End-Expiration (time frame: up to 30 minutes). 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 9 Nov 2015.