Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter (VERO Study)

Study Overview
=================
Brief Summary
-----------------
The Swan-Ganz catheter is the gold standard to measure cardiac output during liver transplantation surgery. This is an invasive hemodynamic monitoring system. The VenArt Cardiac Output (Mespere LifeSciences, Waterloo, Canada) is a new, innovative and non-invasive device that permits hemodynamic monitoring. With a software based on Fick's principle it is able to calculate cardiac output, cardiac index and continuous cardiac output. The hypothesis of this study is to investigate the precision and accuracy of this method versus the standard of care during liver transplantation.

Official Title
-----------------
Hemodynamic Monitoring in Liver Transplant With VEnaRt Cardiac Output Versus Swan-Ganz Catheter VERO Study

Conditions
-----------------
Cardiac Output, Low, Liver Transplant; Complications

Intervention / Treatment
-----------------
* Device: VEnaRt Cardiac Output


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: liver transplantation patients Exclusion Criteria: age < 18 years old combined liver-kidney transplant liver transplant for acute insufficiency no consent of the patient

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OLTx<br>Liver insufficiency patients undergoing transplantation surgery | Device: VEnaRt Cardiac Output<br>* Every patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures | Evaluate the precision of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation | During surgery | 
| Accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output measures | Evaluate the accuracy of VenArt Cardiac Output cardiac output, cardiac index and continuous cardiac output versus the pulmonary catheter in patients undergoing liver transplantation | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation | Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical correlation of cardiac output and cardiac index measures | During surgery | 
| Concordance | Analyze the VenArt Cardiac Output and Swan-Ganz catheter statistical concordance of cardiac output and cardiac index measures | During surgery | 
| Time of device positioning | Evaluate the time necessary to position the VenArt Cardiac Output and Swan-Ganz catheter | During surgery | 
| Device positioning complications | Evaluate the complication during the VenArt Cardiac Output and Swan-Ganz catheter positioning. | During surgery |