Electrical Impedance Tomography of Lung in Child and Young Age (EIT-Lunge)
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|ClinicalTrials.gov Identifier: NCT02290535|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment|
|Obstructive Lung Diseases||Procedure: patients Procedure: probands|
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 :||Observational|
|Actual Enrollment :||192 participants|
|Observational Model:||Case Control|
|Official Title:||Electrical Impedance Tomography of Lung in Child and Young Age|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).
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.
Children and Teenager of 5-18 years without known obstructive pulmonary diseases
Probands will receive the same treatment as patients, but without bronchospasmolysis.
- Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01) [ Time Frame: Baseline ]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.
- Correlation between lung function parameters and extracted parameters of the EIT. [ Time Frame: Baseline ]The present study aims to verify, whether a correlation between lung function parameters and extracted parameters of the EIT exists.
- EIT as a diagnostic method for assessment of lung function [ Time Frame: Baseline ]It will be examined, whether single EIT measurement can be used for assessment of the lung function.
- Regional mechanical transmission behavior [ Time Frame: Baseline ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290535
|University Hospital Aachen|
|Aachen, NRW, Germany, 52074|
|Principal Investigator:||Sylvia Lehmann, MD||Unversity Hospital Aachen|