Electrical Impedance Tomography of Lung in Child and Young Age

NCT02290535 | Completed

• 2 other identifiers: 12-076CIV-14-03-011942
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Lung Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline

Secondary Outcomes (3)

• Correlation between lung function parameters and extracted parameters of the EIT.

  Baseline

• EIT as a diagnostic method for assessment of lung function

  Baseline

• Regional mechanical transmission behavior

  Baseline

Study Arms (2)

Patients

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

Procedure: patients

Probands

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

Procedure: probands

Interventions

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.

Patients

probands PROCEDURE

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

Probands

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sylvia Lehmann, MD

  Unversity Hospital Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: November 14, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: July 16, 2015

Record last verified: 2015-07

Locations

DE (1)