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Electrical Impedance Tomography of Lung in Child and Young Age

Electrical Impedance Tomography of Lung in Child and Young Age

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02290535
Acronym
EIT-Lunge
Enrollment
192
Registered
2014-11-14
Start date
2014-06-30
Completion date
2015-01-31
Last updated
2015-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Lung Diseases

Keywords

obstructive pulmonary disease, children, teenager, EIT (Electrical Impedance Tomography)

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.

Interventions

PROCEDUREpatients

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.

PROCEDUREprobands

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

Sponsors

RWTH Aachen University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (ΔZFEV01)BaselineThe 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

MeasureTime frameDescription
Correlation between lung function parameters and extracted parameters of the EIT.BaselineThe 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 functionBaselineIt will be examined, whether single EIT measurement can be used for assessment of the lung function.
Regional mechanical transmission behaviorBaselineAnother 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026