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

Acute Respiratory Distress Syndrome Clinical Trial

— STRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757522
• Other study ID #: 2012-A01204-39
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Cor Pulmonale
• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Pulmonary Heart Disease
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Right Heart Failure
• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

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