NCT04414410

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

May 12, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1.4 years

First QC Date

May 27, 2020

Last Update Submit

April 28, 2021

Conditions

Keywords

critical care echocardiographyCOVIDpneumoniaICU

Outcome Measures

Primary Outcomes (4)

  • Incidence of Left ventricular systolic dysfunction

    LV systolic dysfunction is defined as an ejection fraction \< 45%

    Up to 28 days

  • Incidence of RV failure

    RV failure is defined as RV/LV end-diastolic area \> 0.8

    up to 28 days

  • Incidence of Vasoplegia

    Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.

    Up to 28 days

  • Incidence of Hypovolemia

    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 Outcomes (5)

  • Relation between plateau pressure and RV failure

    Up to 28 days

  • Relation between tidal volume and RV failure

    Up to 28 days

  • Relation between PaO2 and RV failure

    Up to 28 days

  • Relation between PaCO2 and RV failure

    Up to 28 days

  • Relation between PEEP and RV failure

    Up to 28 days

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID 19 patients admitted in the ICU for respiratory failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ambroise Pare

Boulogne-Billancourt, Hauts De Seine, 92100, France

Location

Related Publications (1)

  • Huang S, Vieillard-Baron A, Evrard B, Prat G, Chew MS, Balik M, Clau-Terre F, De Backer D, Mekontso Dessap A, Orde S, Morelli A, Sanfilippo F, Charron C, Vignon P; ECHO-COVID study group. Echocardiography phenotypes of right ventricular involvement in COVID-19 ARDS patients and ICU mortality: post-hoc (exploratory) analysis of repeated data from the ECHO-COVID study. Intensive Care Med. 2023 Aug;49(8):946-956. doi: 10.1007/s00134-023-07147-z. Epub 2023 Jul 12.

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Antoine Vieillard-Baron, MD, PhD

    Hospital Ambroise Paré Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 4, 2020

Study Start

May 12, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations