Electrical Impedance Tomography of Lung in Child and Young Age - Full Text View

Purpose

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.

Condition	Intervention
Obstructive Lung Diseases	Procedure: patients Procedure: probands


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Electrical Impedance Tomography of Lung in Child and Young Age

Resource links provided by NLM:

MedlinePlus related topics: Lung Diseases

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	192
Study Start Date:	June 2014
Study Completion Date:	January 2015
Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).	Procedure: patients 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.
Probands Children and Teenager of 5-18 years without known obstructive pulmonary diseases	Procedure: probands Probands will receive the same treatment as patients, but without bronchospasmolysis.

Groups/Cohorts

Assigned Interventions

Patients

Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).

Procedure: patients

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.

Probands

Children and Teenager of 5-18 years without known obstructive pulmonary diseases

Procedure: probands

Probands will receive the same treatment as patients, but without bronchospasmolysis.

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.

Eligibility


Ages Eligible for Study:	5 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Patients, who come to the consultation to the Department of Pediatric Pneumology, Children and Adolescent Medicine, University Hospital Aachen, will be recruited and divided into groups by age and diagnosis. Recriutment will be performed in accordance to the inclusion and exclusion criteria.

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02290535

Locations


Germany
University Hospital Aachen
Aachen, NRW, Germany, 52074

Sponsors and Collaborators

RWTH Aachen University

Investigators


Principal Investigator:	Sylvia Lehmann, MD	Unversity Hospital Aachen

More Information


Responsible Party:	RWTH Aachen University
ClinicalTrials.gov Identifier:	NCT02290535 History of Changes
Other Study ID Numbers:	12-076 CIV-14-03-011942 ( Other Identifier: Eudamed-Nr. )
Study First Received:	September 19, 2014
Last Updated:	July 15, 2015

Keywords provided by RWTH Aachen University:


obstructive pulmonary disease children teenager EIT (Electrical Impedance Tomography)

Additional relevant MeSH terms:


Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 21, 2017

Electrical Impedance Tomography of Lung in Child and Young Age (EIT-Lunge)