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

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ClinicalTrials.gov Identifier: NCT02638844
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Study Description
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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.

Condition or disease
ARDS

Study Design
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Study Type : Observational
Actual Enrollment : 49 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: ARDStrain : Assessment of Right Ventricular 2d-strain in Acute Respiratory Distress Syndrome
Study Start Date : December 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : August 2017

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Measure of longitudinal peak systolic strain [ Time Frame: up to 36 hours after Intensive Care Unit admission ]

Secondary Outcome Measures :
  1. Measure of PaO2/FiO2 ratio [ Time Frame: up to 36 hours after Intensive Care Unit admission ]
  2. Ventilator-free days [ Time Frame: 28 days ]
  3. Mortality [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ICU patients with moderate or severe ARDS receiving invasive mechanical ventilation
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638844


Locations
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France
Lemarie Jeremie
Nancy, France, 54000
Sponsors and Collaborators
Central Hospital, Nancy, France
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02638844    
Other Study ID Numbers: CPRC2013 ARDStrain
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Central Hospital, Nancy, France:
echocardiography
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury