Electrical Impedance Tomography of Lung in Child and Young Age

NCT ID: NCT02290535

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-01-31

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.

Conditions

Obstructive Lung Diseases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).

patients

Intervention Type: 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

Children and Teenager of 5-18 years without known obstructive pulmonary diseases

probands

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

probands

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

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sylvia Lehmann, MD

Role: PRINCIPAL_INVESTIGATOR

Unversity Hospital Aachen

Locations

University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

CIV-14-03-011942

Identifier Type: OTHER

Identifier Source: secondary_id

12-076

Identifier Type: -

Identifier Source: org_study_id