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OpenTrials
Completed

NCT Number: NCT01757522

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Right ventricle 2D strain

    Time frame: Duration of mechanical ventilation

    We will assess whether 2D strain can detect a right ventricular dysfunction as compared to standard echocardiographic parameters

Secondary outcomes

  1. Mean right ventricle strain under ventilated patients

    Time frame: 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.

  2. Reproducibility between transthoracic and transesophageal strain measures

    Time frame: 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.

  3. NT pro BNP and pre pro endothelin plasma level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: STRAIN

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Dec 31, 2012
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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