Non-invasive Measurement of Central Hemodynamics by Electrical Impedance Tomography

NCT ID: NCT01412970

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

volume loading

Intervention Type OTHER

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

Interventions

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volume loading

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel A Reuter, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Maisch S, Bohm SH, Sola 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 Sep;39(9):2173-6. doi: 10.1097/CCM.0b013e3182227e65.

Reference Type BACKGROUND
PMID: 21666450 (View on PubMed)

Other Identifiers

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DFG3171_2-1

Identifier Type: -

Identifier Source: org_study_id

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