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

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ClinicalTrials.gov Identifier: NCT01757522
Recruitment Status : Unknown
Verified March 2016 by University Hospital, Grenoble.
Recruitment status was:  Recruiting
First Posted : December 31, 2012
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date December 4, 2012
First Posted Date December 31, 2012
Last Update Posted Date March 15, 2016
Study Start Date January 2013
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 22, 2012)
  • 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 A blood sample is withdrawn at the same time as echocardiography only in the ARDS group.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
Official Title Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population Patients are recruited in our medical intensive care unit at Grenoble University Hospital.
Condition
  • Acute Respiratory Distress Syndrome
  • Right Ventricular Dysfunction
  • Right Heart Failure
  • Acute Cor Pulmonale
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 22, 2012)
290
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01757522
Other Study ID Numbers 2012-A01204-39
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Carole SCHWEBEL, PU/PH University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date March 2016