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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01757522
Other study ID # 2012-A01204-39
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2013
Est. completion date October 25, 2017

Study information

Verified date May 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date October 25, 2017
Est. primary completion date March 17, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France University Hospital of Grenoble Grenoble Cedex 09

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Right ventricle 2D strain We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters Duration of mechanical ventilation
Secondary Mean right ventricle strain under ventilated patients 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. at inclusion
Secondary Reproducibility between transthoracic and transesophageal strain measures In ARDS patients, we record a transthoracic and transesophageal echocardiography. We compare RV strain values obtained from transthoracic and transesophageal echocardiography. Time of mechanical ventilation
Secondary NT pro BNP and pre pro endothelin plasma level 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. At inclusion in ARDS patients
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