Assessment of Right Ventricular 2d-strain in Acute Respir... | NCT02638844

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

NCT02638844

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Feb 5, 2018Actual

Enrollment

49Actual

Phase

Not provided

Conditions

ARDS

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jul 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Dec 21, 2015

First Posted Date

Dec 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2018

Last Update Posted Date

Feb 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure of longitudinal peak systolic strain		up to 36 hours after Intensive Care Unit admission

Secondary Outcomes

Measure	Description	Time Frame
Measure of PaO2/FiO2 ratio		up to 36 hours after Intensive Care Unit admission
Ventilator-free days		28 days
Mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lemarie Jeremie		Nancy		54000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32056017	Derived	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.