Clinical trial NCT01757522: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Right Ventricular Dysfunction
Right Heart Failure
Acute Cor Pulmonale
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited in our medical intensive care unit at Grenoble University Hospital.

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.


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

Primary outcomes:
measure: Right ventricle 2D strain
timeFrame: Duration of mechanical ventilation
Secondary outcomes:
measure: Mean right ventricle strain under ventilated patients
timeFrame: at inclusion
measure: Reproducibility between transthoracic and transesophageal strain measures
timeFrame: Time of mechanical ventilation
measure: NT pro BNP and pre pro endothelin plasma level
timeFrame: At inclusion in ARDS patients
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
state: Cedex 09
Study officials:
affiliation: University Hospital, Grenoble
name: Carole SCHWEBEL, PU/PH
role: PRINCIPAL_INVESTIGATOR
References: