NCT02381756

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

March 5, 2015

Last Update Submit

March 25, 2019

Conditions

Dysfunction, Left Ventricular

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Area under the ROC curve of the value of myocardial strain (GLS)

    Baseline

Interventions

UltrasoundDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients intubated and ventilated

You may qualify if:

  • ICU patients intubated and ventilated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Nadia Benyounes, MD

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2015

First Posted

March 6, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

FR(1)