FLOTRAC/VIGILEO in Acute Circulatory Failure

Study Overview
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Brief Summary
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Acute circulatory failure may be related to hypovolemia. Fluid loading increases stroke volume in approximatively half of challenges. Determining fluid responsiveness prevents unnecessary fluid loading. Passive leg raising (PLR) provides a transient increase of 300 ml in venous return for a short time. The measurement of stroke volume (SV) before and after a PLR test allows physician to detect fluid responsiveness, when stroke volume increases is higher than 15 %. Beside thermodilution, the use of non invasive device to measure stroke volume becomes largely employed. Arterial Pressure based Cardiac Output (APCO), provided by the Flotrac/Vigileo system, does not required specific materials nor repeated calibration. The third generation software is believed to be more accurate and more precise for SV measurement. The aim of this study is to test the performance of the Flotrac/Vigileo device in a situation of rapid venous return changes induced by PLR and then by fluid loading. Patients will be classify posteriorly in responders and non responders, according to the magnitude of the fluid loading-induced SV changes measured by transthoracic echocardiography.

Official Title
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Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure

Conditions
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Critically Ill, Acute Circulatory Failure, Fluid Loading

Intervention / Treatment
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* Device: Flotrac/Vigileo third generation software
* Device: Transthoracic echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systolic arterial pressure < 90 mmHg or Mean arterial pressure < 60 mmHg Heart rate > 100 bpm Norepinephrine infusion Urine output < 0.5 ml/kg/h during at least two consecutive hours skin mottling Capillary refill time > 3 sec Exclusion Criteria: Acute cor pulmonale Ongoing renal replacement therapy Lack of echogenicity during transthoracic echocardiography

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Flotrac/Vigileo third generation software|Measurement of stroke volume according to the arterial pressure waveform|
|Device: Transthoracic echocardiography|Measurement of stroke volume according to the aortic time-velocity integral|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography | Bland-Altman analysis of the whole SV measurements | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness | ROC curve | 30 min | 
| SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness | ROC curve | 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critically ill patient