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Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412970
First Posted: August 9, 2011
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre Suisse d'Electronique et Microtechnique SA
Oregon Health and Science University
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.

Condition Intervention
Comparison of Availability for Prediction of Volume Responsiveness Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation Other: volume loading

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Measurement of Central Hemodynamics and Heart-lung Interactions by Electrical Impedance Tomography

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Ability to assess volume responsiveness by electrical impedance tomography [ Time Frame: within 3 hrs after surgical procedure ]
    Assessment of volume responsiveness by electrical impedance tomography in mechanically ventilated patients by measurement of stroke volume variations under stepwise volume loading


Secondary Outcome Measures:
  • precision of estimation of non invasive measurement of stroke volume variation [ Time Frame: within 3 hours after surgery ]
    precision of estimation of non invasive measurement of stroke volume variation by electrical impedance tomography in comparison to clinically established, invasive advanced hemodynamic monitoring devices


Estimated Enrollment: 30
Study Start Date: July 2016
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
study group
comparison of ability to predict volume responsiveness and precision of measurement of stroke volume variation assessed by electrical impedance tomography in comparison to clinically established invasive hemodynamic monitoring devices, i.e. arterial pulse contour analysis during volume loading procedures
Other: volume loading
volume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis

Detailed Description:
The purpose of this study is to evaluate the ability to measure central hemodynamics and heart-lung interactions non-invasively by electrical impedance tomography and compare it to clinically established hemodynamic monitoring.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Indication for advanced invasive hemodynamic monitoring due to operative procedure
  • Necessity of postoperative invasive ventilation

Exclusion Criteria:

  • Age <18 years
  • known affections cardiac function
  • presence of cardiac arrhythmias
  • contraindication for placement of central venous or femoral artery catheter
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412970


Contacts
Contact: Constantin J Trepte, MD +494074100 ctrepte@uke.de
Contact: Daniel A Reuter, MD +494074100 dreuter@uke.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20251
Contact: Daniel A Reuter, MD, PHD       dreuter@uke.de   
Contact: Constantin JC Trepte, MD       ctrepte@uke.de   
Principal Investigator: Daniel A Reuter, MD, PHD         
Principal Investigator: Constantin JC Trepte, MD         
Principal Investigator: Sebastian A Haas, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Centre Suisse d'Electronique et Microtechnique SA
Oregon Health and Science University
Investigators
Principal Investigator: Daniel A Reuter, MD Universitätsklinikum Hamburg-Eppendorf
  More Information

Publications:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01412970     History of Changes
Other Study ID Numbers: DFG3171_2-1
First Submitted: August 8, 2011
First Posted: August 9, 2011
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
hemodynamic monitoring
volume responsiveness
electrical impedance tomography