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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• France
  • Cedex 09
    • Grenoble, Cedex 09, France, 38043
      • University hospital of Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited in our medical intensive care unit at Grenoble University Hospital.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2013
• Primary Completion (Actual): March 17, 2015
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 22, 2012
• First Posted (Estimate): December 31, 2012

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Pulmonary Heart Disease; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: 2012-A01204-39