Skip to main content
OpenTrials
Completed

NCT Number: NCT02290535

Electrical Impedance Tomography of Lung in Child and Young Age

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Lung Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

patients

Procedure

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

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: EIT-Lunge

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2014
Registry last updated
Jul 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.