Stress Echo and Electric Impedance Tomography (EIT) Pilot Study

Cardiac Output Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01168557
• Other study ID #: Stress Echo - EIT
• Status: Completed
• Phase: N/A
• First received: July 22, 2010
• Last updated: November 26, 2013
• Start date: July 2010
• Est. completion date: September 2012

Study information

• Verified date: November 2013
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiac Output
• Electric Impedance Tomography
• Perfusion
• Stress Echocardiography
• Ventilation

Intervention

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

Locations

Country	Name	City	State
Germany	Medical Clinic I, University Hospital Aachen	Aachen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No