Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres "PreDeARM"

Completed

Phase N/A Results N/A

Trial Description

The principal aim is to assess impact of alveolar recruitment manoeuvres (ARM) on stroke volume variation, evaluated by trans-oesophageal echocardiography (TEE). These variations will be measured on preload dependency or preload independency status. The principal purpose is to determine if variations of stroke volume during standardized ARM can predict the preload dependency status.

Detailed Description

Population studied: anesthetized patients for cardiac surgery of coronary bypass.
Secondary endpoints : - comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM. These mini-invasive systems are : Clearsight system (Edwards Lifescience) and Flotrac system (Edwards Lifescience)
- Difference between pre and post-cardiopulmonary bypass status on principal purpose evaluation

Conditions

Interventions

  • Tee measurement Other
    ARM 1: Kind: Experimental
    Label: TEE monitory system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
    ARM 2: Kind: Experimental
    Label: mini-invasive monitoring system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
  • Flotrac measurement Other
    ARM 1: Kind: Experimental
    Label: TEE monitory system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
    ARM 2: Kind: Experimental
    Label: mini-invasive monitoring system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
  • Clearsight measurement Other
    ARM 1: Kind: Experimental
    Label: TEE monitory system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.
    ARM 2: Kind: Experimental
    Label: mini-invasive monitoring system
    Description: comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Diagnostic
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Variation of stroke volume at the beginning of cardiac surgery No
Secondary Velocity time integral (cm) at the begining of cardiac surgery No
Secondary Cardiac index (l/min/m2) at the begining of cardiac surgery No
Secondary Right ventricle diameter/left ventricle diameter ratio at the begining of cardiac surgery No
Secondary E/A ratio at the begining of cardiac surgery No
Secondary Sus-hepatic vein Doppler profile at the begining of cardiac surgery No
Secondary Invasive arterial pressure (mmHg) at the begining of cardiac surgery No
Secondary Heart rate (pulse/min) at the begining of cardiac surgery No
Secondary Expired CO2 (mmHg) at the begining of cardiac surgery No
Secondary Central venous pressure (mmHg) at the begining of cardiac surgery No
Secondary Pulse pressure variation (%) at the begining of cardiac surgery No
Secondary Perfusion index (pulsoxymeter) at the begining of cardiac surgery No
Secondary Stroke volume (ml) (Flotrac measurement) at the begining of cardiac surgery No
Secondary Stroke volume variation (%) (Flotrac measurement) at the begining of cardiac surgery No
Secondary Cardiac index (l/min/m2) (Flotrac measurement) at the begining of cardiac surgery No
Secondary Pulse pressure variation (%) (Flotrac measurement) at the begining of cardiac surgery No
Secondary Arterial pressure (mmHg) (Flotrac measurement) at the begining of cardiac surgery No
Secondary Stroke volume (ml) (Clearsight measurement) at the begining of cardiac surgery No
Secondary Stroke volume variation (%) (Clearsight measurement) at the begining of cardiac surgery No
Secondary Cardiac index (l/min/m2) (Clearsight measurement) at the begining of cardiac surgery No
Secondary Pulse pressure variation (%) (Clearsight measurement) at the begining of cardiac surgery No
Secondary Arterial pressure (mmHg) (Clearsight measurement) at the begining of cardiac surgery No
Secondary Near infrared spectroscopy : Cerebral SrO2 at the begining of cardiac surgery No

Sponsors