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

Completed

• Conditions: Acute Cor Pulmonale; Acute Respiratory Distress Syndrome; Right Heart Failure; Right Ventricular Dysfunction

• Registration Number: NCT01757522
• Lead Sponsor: University Hospital, Grenoble

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 available

Study Timeline

• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-22
• Study First Posted: 2012-12-31
• Study Start: 2013-01-03
• Primary Completion: 2015-03-17
• Study Completion: 2017-10-25
• Status Verified: 2022-05
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, Cedex 09, France