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Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

NCT ID: NCT01168557

Last Updated: 2013-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Electric Impedance Tomography Stress Echocardiography Cardiac Output Ventilation Perfusion

Keywords

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electric impedance tomography stress-echocardiography ventilation perfusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

EIT (Electrical Impedance Tomography)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Krueger, MD, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen University of Cardiology, Pneumology and Angiology, Aachen, NRW, Germany

Locations

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Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Stress Echo - EIT

Identifier Type: -

Identifier Source: org_study_id