Ultrasound and Left Ventricular Systolic Function

Dysfunction, Left Ventricular Clinical Trial

— EFESE  

Official title:

Ultrasound Evaluation of the Left Ventricular Systolic Function in Intensive Care Unit.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02381756
• Other study ID #: 2014-A01641-46
• Status: Terminated
• Start date: November 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2019
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate, in an intensive care unit, the reproducibility between two non-cardiologists operators and a cardiologist expert in echocardiogram, of the Simpson method and of the calculation of GLS for the evaluation of the systolic function of the left ventricle in critically ill patients intubated and ventilated.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• ICU patients intubated and ventilated

Exclusion Criteria:

• Arrhythmia or variability of heart rate

• Technical impossibility to perform the ultrasound exam

• Known pregnancy or lactation

• Non-affiliation to a social security scheme (beneficiary or assignee)

• Patient under legal protection

• Patient refusal to participate

Related Conditions & MeSH terms

• Dysfunction, Left Ventricular
• Ventricular Dysfunction, Left

Intervention

Device:
• Ultrasound
Cardiac echocardiography to determin the left ventricular ejection fraction by the biplane modified Simpson rule and by the calculation of the Strain Longitudinal Global by 2-D speckle tracking strain echocardiography

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of measurements of the ejection fraction of the left ventricle by two measurement methods and reproducibility of myocardial strain measurements between operators		Baseline
Secondary	Area under the ROC curve of the value of myocardial strain (GLS)		Baseline