FLOTRAC/VIGILEO in Acute Circulatory Failure

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01090791

Acronym

FLOVAC

Enrollment

Registered

2010-03-23

Start date

2011-05-31

Completion date

2016-09-30

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Circulatory Failure, Critically Ill, Fluid Loading

Keywords

critically ill patient

Brief summary

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.

Interventions

DEVICEFlotrac/Vigileo third generation software

Measurement of stroke volume according to the arterial pressure waveform

DEVICETransthoracic echocardiography

Measurement of stroke volume according to the aortic time-velocity integral

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026