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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290535
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : July 16, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Tracking Information
First Submitted Date September 19, 2014
First Posted Date November 14, 2014
Last Update Posted Date July 16, 2015
Study Start Date June 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 10, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 10, 2014)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Electrical Impedance Tomography of Lung in Child and Young Age
Official Title Electrical Impedance Tomography of Lung in Child and Young Age
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition 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.
  • Procedure: probands
    Probands will receive the same treatment as patients, but without bronchospasmolysis.
Study Groups/Cohorts
  • Patients
    Children and Teenager of 5-18 years with obstructive pulmonary disease (asthma, cystic fibrosis, immotile-cilia-syndrome, obstructive bronchitis, obstructive pneumonia).
    Intervention: Procedure: patients
  • Probands
    Children and Teenager of 5-18 years without known obstructive pulmonary diseases
    Intervention: Procedure: probands
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 10, 2014)
192
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02290535
Other Study ID Numbers 12-076
CIV-14-03-011942 ( Other Identifier: Eudamed-Nr. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party RWTH Aachen University
Study Sponsor RWTH Aachen University
Collaborators Not Provided
Investigators
Principal Investigator: Sylvia Lehmann, MD Unversity Hospital Aachen
PRS Account RWTH Aachen University
Verification Date July 2015