NCT01090791

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
• Phase: —
• Study type: Observational
• Enrollment: 1 (actual)
• Sponsor: Hôpital Européen Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critically Ill
• Acute Circulatory Failure
• Fluid Loading

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2010-03-23
• Last updated: 2016-09-08

Locations

2 sites across 1 country: France