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NCT02638844 Clinical Trial

Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

ARDS Clinical Trial

— ARDStrain  

Official title:
ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02638844
Other study ID # CPRC2013 ARDStrain
Secondary ID
Status Completed
Phase N/A
First received December 16, 2015
Last updated February 1, 2018
Start date December 2015
Est. completion date August 2017

Study information
Verified date July 2017
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of right ventricular (RV) function in patients with acute respiratory syndrome (ARDS) is warranted because RV failure is frequent and associated with worse outcome. Transthoracic echocardiography is the cornerstone of RV assessment but it remains challenging. Quantification of RV deformation by speckle-tracking imaging echocardiography (STE) is a widely available and reproducible technique that readily provides an integrated analysis of all segments of the RV. This study aims to investigate the accuracy of STE-derived strain parameters in assessing RV function during ARDS.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date August 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients with moderate or severe ARDS (Berlin definition)

- receiving mechanical ventilation (>48h estimated length)

- Transthoracic echocardiography performed during the first 36h after ICU admission

Exclusion Criteria:

- pregnancy

- protected or deprived of Liberty major

- chronic respiratory disease

- history of clinical right heart failure

- chronic heart failure with LVEF < 35%

- severe valvular heart disease

- under 18 or protected-adults

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Lemarie Jeremie Nancy

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of longitudinal peak systolic strain up to 36 hours after Intensive Care Unit admission
Secondary Measure of PaO2/FiO2 ratio up to 36 hours after Intensive Care Unit admission
Secondary Ventilator-free days 28 days
Secondary Mortality 28 days
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