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

Sponsor
University Hospital, Grenoble (Other)
Overall Status
Unknown status
CT.gov ID
NCT01757522
Collaborator
(none)
290
1
47
6.2

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
290 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Detection of Right Ventricular Dysfunction by 2D Strain During Acute Respiratory Distress Syndrom (ARDS)
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Right ventricle 2D strain [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

  1. Mean right ventricle strain under ventilated patients [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.

  2. Reproducibility between transthoracic and transesophageal strain measures [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.

  3. NT pro BNP and pre pro endothelin plasma level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 University Hospital of Grenoble Grenoble Cedex 09 France 38043

Sponsors and Collaborators

  • University Hospital, Grenoble

Investigators

  • Principal Investigator: Carole SCHWEBEL, PU/PH, University Hospital, Grenoble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01757522
Other Study ID Numbers:
  • 2012-A01204-39
First Posted:
Dec 31, 2012
Last Update Posted:
Mar 15, 2016
Last Verified:
Mar 1, 2016

Study Results

No Results Posted as of Mar 15, 2016