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

• ClinicalTrials.gov Identifier: NCT02290535
• Recruitment Status: Completed
• First Posted: November 14, 2014
• Last Update Posted: July 16, 2015
• Sponsor: RWTH Aachen University
• Information provided by (Responsible Party): RWTH Aachen University

Study Description

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.

Condition or disease	Intervention/treatment
Obstructive Lung Diseases	Procedure: patients; Procedure: probands

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 Design

• Study Type: Observational
• Actual Enrollment: 192 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Electrical Impedance Tomography of Lung in Child and Young Age
• Study Start Date: June 2014
• Actual Primary Completion Date: January 2015
• Actual Study Completion Date: January 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• 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

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
• Other Study ID Numbers: 12-076; CIV-14-03-011942 ( Other Identifier: Eudamed-Nr. )
• First Posted: November 14, 2014
• Last Update Posted: July 16, 2015
• Last Verified: July 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