Echocardiography in Critically-ill Patients With COVID-19 Pneumonia (ECHO-COVID)

April 28, 2021 updated by: Prof Antoine Vieillard-Baron, Hospital Ambroise Paré Paris
Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid outbreak leads that many patients with acute respiratory failure were admitted in the ICU. Many of these patients were ventilated and developed ARDS. Some of them developed deep vein thrombosis and pulmonary embolism. Nothing is already described about the cardiac function and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...). The echo group of the cardiodynamix section of European society of intensive care medicien (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively enter in an international database all the echo studies done as usual care in these patients to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii) incidence of other patterns. Another objective will be to look for any association between some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo studies were done and will be reported following one of the recent systematic review published by the same group (Huang S et al. AOIC 2020).

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Multicenter, international observational retrospective study. Patients admitted in the ICU between March 1th and april 26th for a pneumonia related to SARS COV 2 and who had at least one echocardiography during their stay will be included. Analysis will be retrospective in order to report the hemodynamic profile with left ventricular and right ventricular function. Will be also reported the respiratory settings, the central venous presure if available as well as usual parameters of macrocirculation. All data will be reported in RedCap by the University of sydney (https://redcap.sydney.edu.au/).

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hauts De Seine
      • Boulogne-Billancourt, Hauts De Seine, France, 92100
        • University Hospital Ambroise Pare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

COVID 19 patients admitted in the ICU for respiratory failure.

Description

Inclusion Criteria: patients admitted in the ICU for pneumonia related to SARS COV2 and who had at least 1 critical care echocardiography during the first 28 days.

-

Exclusion Criteria: Patients who did not have any critical care echocardiography during the first 28 days of the ICU stay.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Left ventricular systolic dysfunction
Time Frame: Up to 28 days
LV systolic dysfunction is defined as an ejection fraction < 45%
Up to 28 days
Incidence of RV failure
Time Frame: up to 28 days
RV failure is defined as RV/LV end-diastolic area > 0.8
up to 28 days
Incidence of Vasoplegia
Time Frame: Up to 28 days
Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.
Up to 28 days
Incidence of Hypovolemia
Time Frame: Up to 28 days
Hypovolemia is defined as inspiratory collaspe of the superior vena cava in ventilated patients or virtual inferior vena cava in spontaneously breathing patients.
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between plateau pressure and RV failure
Time Frame: Up to 28 days
Plateau pressure and RV size
Up to 28 days
Relation between tidal volume and RV failure
Time Frame: Up to 28 days
Tidal volume and RV size
Up to 28 days
Relation between PaO2 and RV failure
Time Frame: Up to 28 days
PaO2, PaO2/FiO2, and RV size
Up to 28 days
Relation between PaCO2 and RV failure
Time Frame: Up to 28 days
PaCO2 and RV size
Up to 28 days
Relation between PEEP and RV failure
Time Frame: Up to 28 days
PEEP and RV size
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antoine Vieillard-Baron, MD, PhD, Hospital Ambroise Paré Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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