Assessment of the FLOTRAC/VIGILEO Third Generation Software to Predict Fluid Responsiveness in Critically Ill Patient With Acute Circulatory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Critically Ill
- Sponsor
- Hôpital Européen Marseille
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jerome Allardet-Servent, MD
MD, MSc
Hôpital Européen Marseille
Eligibility Criteria
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
Outcomes
Primary Outcomes
Stroke volume measurement between Flotrac/Vigileo device and transthoracic echocardiography
Time Frame: 30 min
Bland-Altman analysis of the whole SV measurements
Secondary Outcomes
- SVV cut-off with Flotrac/Vigileo to predict fluid responsiveness(30 min)
- SV cut-off with Flotrac/Vigileo and with TEE to predict fluid responsiveness(30 min)