SSdopler: Value of Cardiac Output Monitoring by Supra-sternal Doppler/Echocardiography in Intensive Care Unit

Sponsor
CHU de Reims (Other)
Overall Status
Completed
CT.gov ID
NCT03952871
Collaborator
(none)
62
1
6.2
10

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring in intensive care patients already equipped with an invasive monitoring. This invasive monitoring consists of catheters used to measure the cardiac output allowing the supply of organs and is installed when there is need to monitor the blood flow in different hemodynamic reasons. The patient's care will not be modified, the study just requires a supplementary measure in an exam already perform in the standard care. The principal hypothesis is that we can show a concordance between this non-invasive measure and the standard invasive monitoring.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of this study is to evaluate the concordance between the measurement of cardiac output by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring (trans pulmonary thermodilution or right heart catheterization) in intensive care patients already equipped with an invasive monitoring. Cross sectional study was performed in Reims university hospital. Patients who will be included in this study are patients who already have an invasive cardiac output monitoring such as trans pulmonary thermodilution or right heart catheterization for many reason as septic shock, cardiogenic shock or any shock state. Cardiac output will be measured by supra-sternal and transthoracic echography and by invasive monitoring (trans pulmonary thermodilution or right heart catheterization). Intra-class correlation coefficient will be calculated to assess the concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Value of Cardiac Output Monitoring by Supra-sternal Doppler/Echocardiography in Intensive Care Unit
    Actual Study Start Date :
    Oct 18, 2018
    Actual Primary Completion Date :
    Apr 24, 2019
    Actual Study Completion Date :
    Apr 24, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Intensive care patient with hemodynamic instability

    The study group is composed of intensive care patients which already need an invasive monitoring of the cardiac output because of a shock state.

    Outcome Measures

    Primary Outcome Measures

    1. Concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring [Day 0]

      Value of cardiac blood flow measured by supra sternal ultrasound and invasive monitoring

    Secondary Outcome Measures

    1. Concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by transthoracic echography [Day 0]

      Value of cardiac blood flow measured by supra sternal ultrasound and thransthoracic echography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria :
    • patient admitted in intensive care unit at the Reims University Hospital and in whom invasive monitoring of cardiac output is already placed.
    Exclusion Criteria:
    • Age under 18 yo

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Damien JOLLY Reims France

    Sponsors and Collaborators

    • CHU de Reims

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CHU de Reims
    ClinicalTrials.gov Identifier:
    NCT03952871
    Other Study ID Numbers:
    • PO18127
    First Posted:
    May 16, 2019
    Last Update Posted:
    Jun 12, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CHU de Reims
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 12, 2020