NCT03952871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
Last Updated

June 12, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

May 13, 2019

Last Update Submit

June 11, 2020

Conditions

Keywords

ShockHemodynamic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Concordance between the measurement of cardiac blood flow by non-invasive supra sternal ultrasound and the measurements performed by transthoracic echography

    Day 0

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- patient admitted in intensive care unit at the Reims University Hospital and in whom invasive monitoring of cardiac output is already placed.

You may not qualify if:

  • \- Age under 18 yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 16, 2019

Study Start

October 18, 2018

Primary Completion

April 24, 2019

Study Completion

April 24, 2019

Last Updated

June 12, 2020

Record last verified: 2020-06

Locations