NCT01168557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 27, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

July 22, 2010

Last Update Submit

November 26, 2013

Conditions

Keywords

electric impedance tomographystress-echocardiographyventilationperfusion

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Stress-Echo and EIT

EXPERIMENTAL

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)

Interventions

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

Stress-Echo and EIT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan Krueger, MD, Assoc. Prof.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 23, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 27, 2013

Record last verified: 2013-11

Locations