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Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS) (STRAIN)

This study is currently recruiting participants.
Verified March 2016 by University Hospital, Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757522
First Posted: December 31, 2012
Last Update Posted: March 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
Acute respiratory distress syndrome (ARDS) and mechanical ventilation can lead to right ventricular dysfunction and ultimately right ventricular failure by increasing pulmonary vascular resistances and pressure load. This can be prevented by modifying ventilator settings, using vasopressors or inotropes or even by prone positionning.But to do so, right ventricular dysfonction has to be detected. Echocardiography has emerged as a first line tool to diagnose right heart failure. Recently, strain analysis showed promising results to detect early right ventricle abnormalities in other settings such as pulmonary hypertension or scleroderma. We therefore decided to determine whether 2D strain could help detect early right ventricular dysfunction in ARDS.

Condition
Acute Respiratory Distress Syndrome Right Ventricular Dysfunction Right Heart Failure Acute Cor Pulmonale

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Right ventricle 2D strain [ Time Frame: Duration of mechanical ventilation ]
    We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters


Secondary Outcome Measures:
  • Mean right ventricle strain under ventilated patients [ Time Frame: at inclusion ]
    We measure right ventricle strain (RV strain) in patients under mechanical ventilation for a non-respiratory cause. This allows us to determine the mean value of RV strain under ventilation when there is no respiratory failure.

  • Reproducibility between transthoracic and transesophageal strain measures [ Time Frame: Time of mechanical ventilation ]
    In ARDS patients, we record a transthoracic and transesophageal echocardiography. We compare RV strain values obtained from transthoracic and transesophageal echocardiography.

  • NT pro BNP and pre pro endothelin plasma level [ Time Frame: At inclusion in ARDS patients ]
    These assays are made based on the hypothesis they could help discriminate between patients who will develop a right ventricular dysfunction from those who will not. A blood sample is withdrawn at the same time as echocardiography only in the ARDS group.


Biospecimen Retention:   Samples Without DNA
Plasmatic levels of NT proBNP and pre pro endothelin are monitored in ARDS group to determine whether these biomarkers can help detect right ventricular dysfunction.

Estimated Enrollment: 290
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
ARDS group
Patients under mechanical ventilation since less than 24 hours at inclusion and presenting acute respiratory distress syndrome criteria.
ALI group
Patients under mechanical ventilation and presenting acute lung injury criteria.
Control Group
Patients under mechanical ventilation for a non-respiratory cause

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited in our medical intensive care unit at Grenoble University Hospital.
Criteria

ARDS group

Inclusion Criteria:

  • Need for mechanical ventilation
  • ARDS criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<200, bilateral opacities on Chest imaging, all symptoms appeared within 1 week

Exclusion Criteria:

  • Predictable duration of mechanical ventilation shorter than 48 hours
  • Contraindication to transesophageal echocardiography

ALI group:

Inclusion Criteria:

  • Need for mechanical ventilation
  • ALI criteria met: Respiratory failure not fully explained by cardiac failure, Pao2/FiO2<300, bilateral opacities on Chest imaging, all symptoms appeared within 1 week

Exclusion Criteria:

  • Predictable duration of mechanical ventilation shorter than 48 hours

Control Group:

Inclusion Criteria:

  • Need for mechanical ventilation for a non-respiratory cause

Exclusion Criteria:

  • Need for FiO2>30%
  • Known cardiac abnormalities
  • Cardiac drugs intake during last 24 hours
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01757522


Contacts
Contact: Carole SCHWEBEL, PU/PH 33-476768779 cschwebel@chu-grenoble.fr

Locations
France
University Hospital of Grenoble Recruiting
Grenoble, Cedex 09, France, 38043
Contact: Carole SCHWEBEL, PU/PH    33-476768779    cschwebel@chu-grenoble.fr   
Contact: Cyrielle CLAPE, CRA    33-476767109    cclape@chu-grenoble.fr   
Principal Investigator: Carole SCHWEBEL, PU/PH         
Sub-Investigator: Agnes BONADONA, PH         
Sub-Investigator: Rebecca HAMIDFAR, PH         
Sub-Investigator: Clemence MINET, PH         
Sub-Investigator: Claire ARA SOMOHANO, PH         
Sub-Investigator: Patrice FAURE, PU/PH         
Sub-Investigator: Bertrand TOUSSAINT, PU/PH         
Sub-Investigator: Carole SAUNIER, PH         
Sub-Investigator: Nicolas TERZI, PU/PH         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Carole SCHWEBEL, PU/PH University Hospital, Grenoble
  More Information

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01757522     History of Changes
Other Study ID Numbers: 2012-A01204-39
First Submitted: December 4, 2012
First Posted: December 31, 2012
Last Update Posted: March 15, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Heart Failure
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Ventricular Dysfunction
Ventricular Dysfunction, Right
Pulmonary Heart Disease
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury