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Status unknownNCT04414410ECHO-COVIDUpdated Apr 29, 2021

Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

An observational study in COVID and Sars-CoV2, sponsored by Hospital Ambroise Paré Paris. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by Hospital Ambroise Paré Paris · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,500
Sex
All
01

Study 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).

Read the 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/).

02

Conditions studied

  • COVID
  • Sars-CoV2

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Keywords

  • critical care echocardiography
  • COVID
  • pneumonia
  • ICU
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Hospital Ambroise Paré Paris is the lead sponsor of 23 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

COVID 19 patients admitted in the ICU for respiratory failure.

Eligibility criteria

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.

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

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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,500 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Incidence of Left ventricular systolic dysfunction

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

    Time frame: Up to 28 days

  2. Incidence of RV failure

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

    Time frame: up to 28 days

  3. Incidence of Vasoplegia

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

    Time frame: Up to 28 days

  4. 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.

    Time frame: Up to 28 days

Secondary outcomes

  1. Relation between plateau pressure and RV failure

    Plateau pressure and RV size

    Time frame: Up to 28 days

  2. Relation between tidal volume and RV failure

    Tidal volume and RV size

    Time frame: Up to 28 days

  3. Relation between PaO2 and RV failure

    PaO2, PaO2/FiO2, and RV size

    Time frame: Up to 28 days

  4. Relation between PaCO2 and RV failure

    PaCO2 and RV size

    Time frame: Up to 28 days

  5. Relation between PEEP and RV failure

    PEEP and RV size

    Time frame: Up to 28 days

07

Study locations

1 site
  • University Hospital Ambroise Pare
    Boulogne-Billancourt, Hauts De Seine 92100, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04414410
Lead sponsor
Hospital Ambroise Paré Paris
Responsible party
Prof Antoine Vieillard-Baron (Professor, Hospital Ambroise Paré Paris) — Principal investigator
First posted
Jun 4, 2020
Start date
May 12, 2020
Primary completion
Sep 30, 2021 (estimated)
Completion
Sep 30, 2021 (estimated)
Last update
Apr 29, 2021

Study contacts

Antoine Vieillard-Baron, MD, PhD
principal investigator · Hospital Ambroise Paré Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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