Preload Dependency Evaluation With Stroke Volume Variation During Alveolar Recruitment Manoeuvres

NCT ID: NCT02678559

Last Updated: 2017-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TEE monitory system

comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

Group Type EXPERIMENTAL

tee measurement

Intervention Type OTHER

flotrac measurement

Intervention Type OTHER

clearsight measurement

Intervention Type OTHER

mini-invasive monitoring system

comparison between TEE and mini-invasive monitoring systems in accuracy of measurement of stroke volume variation during ARM.

Group Type EXPERIMENTAL

tee measurement

Intervention Type OTHER

flotrac measurement

Intervention Type OTHER

clearsight measurement

Intervention Type OTHER

Interventions

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tee measurement

Intervention Type OTHER

flotrac measurement

Intervention Type OTHER

clearsight measurement

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

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France

Other Identifiers

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CHU-0254

Identifier Type: -

Identifier Source: org_study_id

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