Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

Sponsor
RWTH Aachen University (Other)
Overall Status
Completed
CT.gov ID
NCT01168557
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: EIT (Electrical Impedance Tomography)
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Jul 1, 2010
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. influence of cardiac output on EIT measurements (feasibility) [single measurement of 45 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Medical Clinic I, University Hospital Aachen Aachen Nordrhein-Westfalen Germany 52074

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01168557
Other Study ID Numbers:
  • Stress Echo - EIT
First Posted:
Jul 23, 2010
Last Update Posted:
Nov 27, 2013
Last Verified:
Nov 1, 2013
Keywords provided by RWTH Aachen University

Study Results

No Results Posted as of Nov 27, 2013