Clinical trial NCT02290535: Electrical Impedance Tomography of Lung in Child and Young Age
Official title: Electrical Impedance Tomography of Lung in Child and Young Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Lung Diseases
Keywords: obstructive pulmonary disease
children
teenager
EIT (Electrical Impedance Tomography)
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 192
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between lung function parameters and extracted parameters of the EIT.
timeFrame: Baseline
measure: EIT as a diagnostic method for assessment of lung function
timeFrame: Baseline
measure: Regional mechanical transmission behavior
timeFrame: Baseline
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital Aachen
state: NRW
Study officials:
affiliation: Unversity Hospital Aachen
name: Sylvia Lehmann, MD
role: PRINCIPAL_INVESTIGATOR
References: