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

NCT01757522 | Completed

• 1 other identifier: 2012-A01204-39
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean right ventricle strain under ventilated patients

  at inclusion

• Reproducibility between transthoracic and transesophageal strain measures

  Time of mechanical ventilation

• NT pro BNP and pre pro endothelin plasma level

  At inclusion in ARDS patients

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Predictable duration of mechanical ventilation shorter than 48 hours
• Contraindication to transesophageal echocardiography
• ALI group:
• 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
• Predictable duration of mechanical ventilation shorter than 48 hours
• Control Group:
• Need for mechanical ventilation for a non-respiratory cause
• Need for FiO2\>30%
• Known cardiac abnormalities
• Cardiac drugs intake during last 24 hours

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital of Grenoble

Grenoble, Cedex 09, 38043, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasmatic levels of NT proBNP and pre pro endothelin are monitored in ARDS group to determine whether these biomarkers can help detect right ventricular dysfunction.

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventricular Dysfunction, Right; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Carole SCHWEBEL, PU/PH

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 31, 2012
• Study Start: January 3, 2013
• Primary Completion: March 17, 2015
• Study Completion: October 25, 2017
• Last Updated: November 8, 2022

Record last verified: 2022-05

Locations

FR (1)