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

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ClinicalTrials.gov Identifier: NCT03952871
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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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
Shock

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
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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 : October 18, 2018
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Groups and Cohorts
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Group/Cohort
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
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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 [ Time Frame: 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 [ Time Frame: Day 0 ]
    Value of cardiac blood flow measured by supra sternal ultrasound and thransthoracic echography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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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): NCT03952871


Locations
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France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03952871    
Other Study ID Numbers: PO18127
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Shock
Hemodynamic
Additional relevant MeSH terms:
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Shock
Pathologic Processes