Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
ARDStrain
ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
1 other identifier
observational
49
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 16, 2015
CompletedFirst Posted
Study publicly available on registry
December 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFebruary 5, 2018
July 1, 2017
1.6 years
December 16, 2015
February 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of longitudinal peak systolic strain
up to 36 hours after Intensive Care Unit admission
Secondary Outcomes (3)
Measure of PaO2/FiO2 ratio
up to 36 hours after Intensive Care Unit admission
Ventilator-free days
28 days
Mortality
28 days
Eligibility Criteria
ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation
You may qualify if:
- patients with moderate or severe ARDS (Berlin definition)
- receiving mechanical ventilation (\>48h estimated length)
- Transthoracic echocardiography performed during the first 36h after ICU admission
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lemarie Jeremie
Nancy, 54000, France
Related Publications (1)
Lemarie J, Maigrat CH, Kimmoun A, Dumont N, Bollaert PE, Selton-Suty C, Gibot S, Huttin O. Feasibility, reproducibility and diagnostic usefulness of right ventricular strain by 2-dimensional speckle-tracking echocardiography in ARDS patients: the ARD strain study. Ann Intensive Care. 2020 Feb 13;10(1):24. doi: 10.1186/s13613-020-0636-2.
PMID: 32056017DERIVED
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2015
First Posted
December 23, 2015
Study Start
December 1, 2015
Primary Completion
July 1, 2017
Study Completion
August 1, 2017
Last Updated
February 5, 2018
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share