Electrical Impedance Tomography of Lung in Child and Young Age

Obstructive Lung Diseases Clinical Trial

— EIT-Lunge  

Official title:

Electrical Impedance Tomography of Lung in Child and Young Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02290535
• Other study ID #: 12-076
• Secondary ID: CIV-14-03-011942
• Status: Completed
• Phase: N/A
• First received: September 19, 2014
• Last updated: July 15, 2015
• Start date: June 2014
• Est. completion date: January 2015

Study information

• Verified date: July 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Lung Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Robustness of change in electrical impedance based on the forced expiratory volume in 1 second (?ZFEV01)	The robustness of ?ZFEV1.0 (= change in electrical impedance based on the FVC FEV1.0) and t (= mechanical time constant t which classifies the regional and global lung mechanics) and their clinical relevance will be investigated.	Baseline	No
Secondary	Correlation between lung function parameters and extracted parameters of the EIT.	The present study aims to verify, whether a correlation between lung function parameters and extracted parameters of the EIT exists.	Baseline	No
Secondary	EIT as a diagnostic method for assessment of lung function	It will be examined, whether single EIT measurement can be used for assessment of the lung function.	Baseline	No
Secondary	Regional mechanical transmission behavior	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.	Baseline	No