Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

• Conditions: COVID; Sars-CoV2

• Registration Number: NCT04414410
• Lead Sponsor: Hospital Ambroise Paré Paris

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).

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 Timeline

• Study Start: 2020-05-12
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Left ventricular systolic dysfunction	Up to 28 days	LV systolic dysfunction is defined as an ejection fraction \< 45%
Incidence of Vasoplegia	Up to 28 days	Vasoplegia is defined as a normal or supranormal LV ejection fraction without echocarduiographic signs of hypovolemia.
Incidence of Hypovolemia	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.
Incidence of RV failure	up to 28 days	RV failure is defined as RV/LV end-diastolic area \> 0.8

Secondary Outcome Measures

Name	Time	Method
Relation between plateau pressure and RV failure	Up to 28 days	Plateau pressure and RV size
Relation between tidal volume and RV failure	Up to 28 days	Tidal volume and RV size
Relation between PaO2 and RV failure	Up to 28 days	PaO2, PaO2/FiO2, and RV size
Relation between PaCO2 and RV failure	Up to 28 days	PaCO2 and RV size
Relation between PEEP and RV failure	Up to 28 days	PEEP and RV size

Trial Locations

Locations (1)

University Hospital Ambroise Pare; 🇫🇷 Boulogne-Billancourt, Hauts De Seine, France