- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290535
Electrical Impedance Tomography of Lung in Child and Young Age (EIT-Lunge)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the present study is verification of the correlation between EIT-derived data and following extracted parameters of the pulmonary function:
- forced expiratory volume in 1 second (FEV 1)
- forced vital capacity (FVC)
- relative forced expiratory volume in 1 second (FEV1/FVC)
- maximal expiratory flow (MEF 25)
- total lung capacity (TLC)
- resistance (Raw).
These findings could bring out new prospective opportunity for pulmonary function tests without cooperation.
Furthermore, the study aims to clarify whether EIT technique can be used for regional pulmonary function testing.
In addition, dynamic lung function parameter and static radiological techniques will be correlated with EIT.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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NRW
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Aachen, NRW, Germany, 52074
- University Hospital Aachen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients: children and teenagers with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive brochitis, obstructive pneumonia).
- Probands: Children and Teenager of 5-18 years without known obstructive pulmonary diseases
Exclusion Criteria:
- active implants (ICD, CRT)
- metal in chest
- artificial heart valve
- children < 5 years
- pregnant and lactating females
- Persons, who are in relationship of dependence to the investigator / sponsor
- Persons, who are not able to understand and follow the instructions of the study personnel.
- Lack of signed informed consent (by legal guardian /proband)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).
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The 16-electrode belt will be applied to patient's chest.
Following vital signs will be recorded: respiratory rate at rest breathing, heart rate, transcutaneous oxygen saturation.
Then impulse oscillometry (IOS) will be performed in a sitting position.
After that, subjects with cooperation willingness will get a body plethysmography.
A spirometry / forced breathing maneuvers will be performed.
All patients will receive 2 strokes salbutamol inhaler for bronchospasmolysis.
Please note that inhalation of salbutamol is not study related.
It is used in the clinical routine to examine the reversibility of the bronchial obstruction in patients with obstructive lung disease in course of the lung function test.
Ten minutes later measurements described above will be repeated.
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Probands
Children and Teenager of 5-18 years without known obstructive pulmonary diseases
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Probands will receive the same treatment as patients, but without bronchospasmolysis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
Time Frame: Baseline
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The robustness of ΔZFEV1.0 (= change in electrical impedance based on the FVC FEV1.0) and τ (= mechanical time constant τ which classifies the regional and global lung mechanics) and their clinical relevance will be investigated.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between lung function parameters and extracted parameters of the EIT.
Time Frame: Baseline
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The present study aims to verify, whether a correlation between lung function parameters and extracted parameters of the EIT exists.
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Baseline
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EIT as a diagnostic method for assessment of lung function
Time Frame: Baseline
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It will be examined, whether single EIT measurement can be used for assessment of the lung function.
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Baseline
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Regional mechanical transmission behavior
Time Frame: Baseline
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Another secondary outcome is the local mechanical transmission behavior as an index of pulmonary status.
By using the correlation between results gained from EIT and results from impulse oscillometry (IOS) differentiation between central and peripheral obstruction of respiratory tracts will be proved.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sylvia Lehmann, MD, Unversity Hospital Aachen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-076
- CIV-14-03-011942 (Other Identifier: Eudamed-Nr.)
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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