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

Shock Clinical Trial

— SSdopler  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03952871
• Other study ID #: PO18127
• Status: Completed
• Start date: October 18, 2018
• Est. completion date: April 24, 2019

Study information

• Verified date: June 2020
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by invasive monitoring	Value of cardiac blood flow measured by supra sternal ultrasound and invasive monitoring	Day 0
Secondary	Concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by transthoracic echography	Value of cardiac blood flow measured by supra sternal ultrasound and thransthoracic echography	Day 0