Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

This study is not yet open for participant recruitment.

Verified August 2011 by Universitätsklinikum Hamburg-Eppendorf

Sponsor:

Collaborators:

Centre Swiss d'Electronique et Microtechnique

Oregon Health and Science University

Information provided by:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT01412970

First received: August 8, 2011

Last updated: NA

Last verified: August 2011

History: No changes posted

Tracking Information

First Received Date ^ICMJE

August 8, 2011

Last Updated Date

August 8, 2011

Start Date ^ICMJE

September 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

Official Title ^ICMJE

Non-invasive Measurement of Central Hemodynamics and Heart-lung Interactions by Electrical Impedance Tomography

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Comparison of Availability for Prediction of Volume Responsiveness
Comparison of Limits of Agreement for Invasive and Non-invasive Measurement of Stroke Volume Variation

Intervention ^ICMJE

Other: volume loading

volume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis

Study Arm (s)

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

Intervention: Other: volume loading

Publications *

Maisch S, Bohm SH, Solà J, Goepfert MS, Kubitz JC, Richter HP, Ridder J, Goetz AE, Reuter DA. Heart-lung interactions measured by electrical impedance tomography. Crit Care Med. 2011 Jun 9; [Epub ahead of print]

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01412970

Other Study ID Numbers ^ICMJE

DFG3171_2-1

Has Data Monitoring Committee

Responsible Party

Prof. Dr. med. Daniel A. Reuter, Universitätsklinikum Hamburg-Eppendorf

Study Sponsor ^ICMJE

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^ICMJE

Centre Swiss d'Electronique et Microtechnique
Oregon Health and Science University

Investigators ^ICMJE

Principal Investigator:

Daniel A Reuter, MD

Universitätsklinikum Hamburg-Eppendorf

Information Provided By

Universitätsklinikum Hamburg-Eppendorf

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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