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Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

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ClinicalTrials.gov Identifier: NCT01412970
Recruitment Status : Unknown
Verified August 2015 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2011
Last Update Posted : August 13, 2015
Sponsor:
Collaborators:
Centre Suisse d'Electronique et Microtechnique SA
Oregon Health and Science University
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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 or disease Intervention/treatment Phase
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 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : July 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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



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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

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

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

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