Electrical Impedance Tomography of Lung in Child and Young Age

Completed

• Conditions: Obstructive Lung Diseases
• Interventions: Procedure: patients; Procedure: probands

• Registration Number: NCT02290535
• Lead Sponsor: RWTH Aachen University

Brief Summary

The investigator will determine a compliance of two diagnostic techniques (EIT and Body plethysmography) in collective of children and teenagers with obstructive lung disease and a matched control group.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	patients	Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).
Probands	probands	Children and Teenager of 5-18 years without known obstructive pulmonary diseases

Primary Outcome Measures

Name	Time	Method
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between lung function parameters and extracted parameters of the EIT.	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	Baseline	It will be examined, whether single EIT measurement can be used for assessment of the lung function.
Regional mechanical transmission behavior	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.

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, NRW, Germany