Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

University Hospital, Clermont-Ferrand1 site in 1 country24 target enrollmentFebruary 2016

ConditionsCoronary Artery Disease Coronary Artery Bypass Hypovolemia Anesthesia, General Pulmonary Atelectasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: University Hospital, Clermont-Ferrand
Enrollment: 24
Locations: 1
Primary Endpoint: Variation of stroke volume
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

December 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

University Hospital, Clermont-Ferrand

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patient Undergoing a surgical procedure of coronary artery bypass, with cardiopulmonary bypass Written consent collected

Exclusion Criteria

•Emergency case
•Pericardial effusion
•Aortic or mitral valvulopathy
•Contraindication for : TEE, alveolar recruitment manoeuvre (emphysema, pneumothorax, hemodynamic instability), Ringer Lactate solution infusion
•Bad echogenicity
•Patient refusal to participate to the study
•No health insurance

Outcomes

Primary Outcomes

Variation of stroke volume

Time Frame: at the beginning of cardiac surgery

Variation of stroke volume measured by TEE, induced by a standardized ARM, at the beginning of cardiac surgery

Secondary Outcomes

Pulse pressure variation (%) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Perfusion index (pulsoxymeter)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Right ventricle diameter/left ventricle diameter ratio(After the cardiopulmonary bypass period, when sternotomy will be closed)
Cardiac index (l/min/m2)(After the cardiopulmonary bypass period, when sternotomy will be closed)
E/A ratio(After the cardiopulmonary bypass period, when sternotomy will be closed)
Sus-hepatic vein Doppler profile(After the cardiopulmonary bypass period, when sternotomy will be closed)
Heart rate (pulse/min)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Invasive arterial pressure (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Stroke volume variation (%) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Velocity time integral (cm)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Cardiac index (l/min/m2) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Expired CO2 (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Arterial pressure (mmHg) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Central venous pressure (mmHg)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Stroke volume (ml) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Stroke volume variation (%) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Stroke volume (ml) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Pulse pressure variation (%)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Cardiac index (l/min/m2) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Near infrared spectroscopy : Cerebral SrO2(After the cardiopulmonary bypass period, when sternotomy will be closed)
Arterial pressure (mmHg) (Clearsight measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)
Pulse pressure variation (%) (Flotrac measurement)(After the cardiopulmonary bypass period, when sternotomy will be closed)