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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. (see Contacts and Locations)
Verified January 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01757522
First received: December 4, 2012
Last updated: October 18, 2013
Last verified: January 2013

December 4, 2012
October 18, 2013
January 2013
December 2015   (final data collection date for primary outcome measure)
Right ventricle 2D strain [ Time Frame: Duration of mechanical ventilation ] [ Designated as safety issue: No ]
We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters
Same as current
Complete list of historical versions of study NCT01757522 on ClinicalTrials.gov Archive Site
  • Mean right ventricle strain under ventilated patients [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 A blood sample is withdrawn at the same time as echocardiography only in the ARDS group.
Same as current
Not Provided
Not Provided
 
Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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.

Non-Probability Sample

Patients are recruited in our medical intensive care unit at Grenoble University Hospital.

  • Acute Respiratory Distress Syndrome
  • Right Ventricular Dysfunction
  • Right Heart Failure
  • Acute Cor Pulmonale
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
290
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: POTTON Leila, MD 33-476768779 LPotton@chu-grenoble.fr
France
 
NCT01757522
2012-A01204-39
No
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Leila POTTON, ACC University Hospital, Grenoble
University Hospital, Grenoble
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP