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Electric Impedance Tomography (SVEIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639468
Recruitment Status : Terminated (protocol not fully appropriate technical issues with EIT device)
First Posted : December 24, 2015
Last Update Posted : November 27, 2018
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Brief Summary:
Evaluation of electrical impedance tomography to non-invasively monitor stroke volume when compared to reference measurements performed via right heart thermodilution

Condition or disease Intervention/treatment Phase
Stroke Volume Device: Stroke Volume estimation using electrical impedance tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Electric Impedance Tomography
Study Start Date : April 2016
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

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



Primary Outcome Measures :
  1. Correlation of stroke volume values measured via pulmonary catheter compared to EIT-derived stroke volume estimates. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02639468


Locations
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Switzerland
CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
Centre Hospitalier Universitaire Vaudois
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Responsible Party: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
ClinicalTrials.gov Identifier: NCT02639468    
Other Study ID Numbers: SVEIT
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No