Electric Impedance Tomography (SVEIT)

November 26, 2018 updated by: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing cardiac surgery which requires placement of pulmonary catheter
  • Patients with right heart catheterization for diagnostic or therapeutic reasons

Exclusion Criteria:

  • Patient unable to understand the study
  • Patient unable to provide written consent or refusing his/her participation
  • Patient suffering from a severe valvular insufficiency
  • Patient allergic to ECG electrodes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tomographie par impédance électrique
Device: Stroke Volume estimation using electrical impedance tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

December 21, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 26, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • SVEIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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