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Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

This study is currently recruiting participants.
Verified June 2012 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01168557
First received: July 22, 2010
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

Electric Impedance Tomography (EIT) is a technique based on the injection of small currents and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax.It is a radiation free, non- invasive and portable lung imaging technique. Impedance changes in lung ventilation as well as in lung perfusion can be shown. To investigate lung perfusion by EIT measurements, cardiac output measured by routinely undergone stress echocardiography at rest and stress are compared to parameters measured by EIT.


Condition Intervention
Electric Impedance Tomography
Stress Echocardiography
Cardiac Output
Ventilation
Perfusion
 Device: EIT (Electrical Impedance Tomography)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Stress Echo and Electric Impedance Tomography (EIT) Pilot Study to Investigate the Influence of Cardiac Output on Parameters of the EIT

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • influence of cardiac output on EIT measurements (feasibility) [ Time Frame: single measurement of 45 minutes ] [ Designated as safety issue: No ]
    It will be investigated if a change in cardiac output, which is measured by stress-echocardiography by dobutamine, has an influence on the parameters determined by EIT measurements.


Estimated Enrollment: 15
Study Start Date: July 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stress-Echo and EIT
Patients who routinely undergo stress-echocardiography will additionally be measured by EIT using a rubber belt, which will be placed around their chest
 Device: EIT (Electrical Impedance Tomography)
EIT measurement; concomitant to stress echocardiography (about 45 minutes) EIT measurements (1 minute) are performed at rest, at low dobutamine stress, at peak and at relaxation

Detailed Description:

In 15 patients who routinely have to undergo stress echocardiography Electric Impedance Tomography (EIT) measurements are performed parallel to measurements of cardiac output at rest, low stress generated by a dosage of 10µg dobutamine, at peak generated by a dosage between 20-40µg dobutamine (individually)and at relaxation(pulse <100). Therefore prior to the examination a rubber belt with 16 integrated electrocardiographic electrodes is placed around the thorax at the fifth or sixth intercostal space, connected with an EIT device. EIT data are generated by application of a small alternating electrical current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Changes due to ventilation as well as changes due to perfusion will be measured by EIT. Cardiac output will be retrospectively compared to parameters of the EIT. EIT data are stored in a database and pseudonymized evaluated in relationship to routinely measured stress echocardiography data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male patients >18 years who routinely have to undergo stress echocardiography
  • ejection fraction >50%
  • able to give informed consent

Exclusion Criteria:

  • restrictive lung diseases
  • active implants and heart pace makers and implanted converter defibrillator
  • foreign metallic objects in the thorax
  • Not adequate quality of imaging of stress echocardiography
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168557

Contacts
Contact: Stefan Krueger, MD, Assoc. Prof. 0049 241 80 ext 80092 stkrueger@ukaachen.de
Contact: Sigrid Gloeggler, M. Sc. 0049 241 80 ext 80202 sgloeggler@ukaachen.de

Locations
Germany
Medical Clinic I, University Hospital Aachen Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Stefan Krüger, PD Dr. med.     0049 241 80 ext 80092     stkrueger@ukaachen.de    
Principal Investigator: Stefan Krueger, MD, PhD            
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Stefan Krueger, MD, Assoc. Prof. RWTH Aachen University of Cardiology, Pneumology and Angiology, Aachen, NRW, Germany
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01168557     History of Changes
Other Study ID Numbers: Stress Echo - EIT
Study First Received: July 22, 2010
Last Updated: June 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
electric impedance tomography
stress-echocardiography
ventilation
perfusion

ClinicalTrials.gov processed this record on May 22, 2013