Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Collaborators:
Centre Swiss d'Electronique et Microtechnique
Oregon Health and Science University
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01412970
First received: August 8, 2011
Last updated: February 17, 2014
Last verified: June 2013
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Swiss d'Electronique et Microtechnique
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
Study First Received: August 8, 2011
Last Updated: February 17, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on September 18, 2014