The Short-term Effect of ELTGOL on Pulmonary Ventilation Valued Through Electrical Impedance Tomography in Cystic Fibrosis Patients

November 6, 2015 updated by: Amanda Silva Couto, Universidade Federal de Pernambuco

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Recruiting
        • Instituto de Medicina Integral Professor Fernando Figueira
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ELTGOL
Other: ELTGOL
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)
Device: Acapella
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.
Active Comparator: Acapella
Other: ELTGOL
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)
Device: Acapella
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Average Electrical Impedance on the End-Expiration
Time Frame: up to 30 minutes
up to 30 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Dyspnea assessed by the Borg scale
Time Frame: baseline, one minute and thirtieth minutes
baseline, one minute and thirtieth minutes
Oxygen saturation assessed by oximeter
Time Frame: baseline, one minute and thirtieth minutes
baseline, one minute and thirtieth minutes
Preferred technique assessed by an open question
Time Frame: up to 3 minutes
up to 3 minutes
Adverse Effects associeted with ELTGOL and Acapella assessed by an open question
Time Frame: baseline, one minute and thirtieth minutes
baseline, one minute and thirtieth minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal de Pernambuco

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 37906314.3.0000.5208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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