Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

Stress Echo and Electric Impedance Tomography (EIT) Pilot Study to Investigate the Influence of Cardiac Output on Parameters of the EIT

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.

Study Overview

• Status: Completed
• Conditions: Ventilation; Cardiac Output; Stress Echocardiography; Perfusion; Electric Impedance Tomography
• Intervention / Treatment: Device: EIT (Electrical Impedance Tomography)

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Medical Clinic I, University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
influence of cardiac output on EIT measurements (feasibility)	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.	single measurement of 45 minutes

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Stefan Krueger, MD, Assoc. Prof., RWTH Aachen University of Cardiology, Pneumology and Angiology, Aachen, NRW, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 22, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: ventilation; perfusion; electric impedance tomography; stress-echocardiography
• Other Study ID Numbers: Stress Echo - EIT