A Comparison of Invasive and Non-invasive Measurement of CI and SVR in Liver Transplantation

Study Overview
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Brief Summary
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Patients who are scheduled to receive living donor liver transplantation will be monitored with a radial and femoral arterial line. A pulmonary artery catheter will also be placed and central venous pressure, cardiac index, and cardiac output will also be monitored. Simultaneously, on the middle finger of the hand where the radial artery is monitored, Clearsight (Edwards Lifesciences, Irvine, CA), a finger cuff, is placed and noninvasive blood pressure, cardiac output, cardiac index are measured. Using the VitalDB program, the parameters measured with the invasive methods and the parameters obtained by the noninvasive method are compared.

Detailed Description
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In many end stage liver disease patients, cardiac output (CO) is increased and systemic vascular resistance (SVR) is decreased. During liver transplantation it is common to see hemodynamic instability due to massive blood loss and clamping of the major vessels. As a result invasive monitoring via a pulmonary catheter is usually done to continuously monitor the CO and SVR. However, because of its invasiveness, complications such as pulmonary artery rupture and ventricular arrhythmia can occur. Clearsight (Edwards Lifesciences, Irvine, CA) is a noninvasive technique using a finger cuff to measure not only blood pressure but also CO and cardiac index (CI). There have been previous reports on the correlation of this noninvasive method in other patient populations but no studies have been done in liver recipients. Also no studies have been done comparing SVR. Patients presenting for living donor liver transplantation are anesthetized according to the SNUH protocol. Right radial and femoral arterial lines are placed. A central catheter is placed in the right jugular vein and a pulmonary artery catheter (Swan-Ganz CCOmbo CCO/SvO2™; Edward Lifesciences LLC, Irvine, CA, USA) is placed. This is connected to the Vigilance™ hemodynamic monitor (Edwards Lifesciences) and central venous pressure (CVP), CO, CI are monitored and SVR is calculated by the following equation: SVR=(Mean arterial pressure-CVP)*80/CO. The Clearsight system is connected after the finger cuff is placed on the middle finger of the right hand. Blood pressure, CO, CI are measured and SVR is calculated. The variables are compared in the following phases: Phase 1 (preanhepatic1): induction complete (baseline) Phase 2 (preanhepatic2): induction - recipient hepatectomy Phase 3 (anhepatic1): recipient hepatectomy - Inferior Vena Cava (IVC) clamping Phase 4 (anhepatic2): IVC clamping - reperfusion Phase 5 (neohepatic1 [reperfusion]) Reperfusion - 5 minutes postreperfusion Phase 6 (neohepatic2): 20 minutes after reperfusion Phase 7 (neohepatic3): 1 hour after reperfusion The investigators hypothesize that the noninvasive hemodynamic monitoring method by the Clearsight will be able to replace the invasive monitoring by the pulmonary artery catheter.

Official Title
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A Comparison of Invasive and Non-invasive Measurement of Cardiac Index and Systemic Vascular Resistance in Living Donor Liver Transplantation

Conditions
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Living Donor Liver Transplantation

Intervention / Treatment
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* Diagnostic Test: Clearsight (finger cuff)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent Exclusion Criteria: Patients with atrial fibrillation Contraindications to pulmonary artery catheterization or needing attention to insertion of pulmonary artery catheter: right-sided endocarditis, tumors, right sided valvular disease, left bundle branch block Patients with obstructive vascular disease in the upper extremities, anatomical deformities in the upper extremities, Raynaud syndrome, etc.

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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clearsight (finger cuff)<br> | Diagnostic Test: Clearsight (finger cuff)<br>* Clearsight (Edwards Lifesciences, Irvine, CA), a noninvasive technique, uses a finger cuff to measure blood pressure, cardiac output (CO) and cardiac index. Systemic vascular resistance (SVR) is calculated by the following equation: SVR=(Mean arterial pressure-Central venous pressure)*80/CO.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline) | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline) | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 4 (anhepatic 2): 10 minutes after IVC clamping | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 4 (anhepatic 2): 10 minutes after IVC clamping | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 6(neohepatic2): 20 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 6(neohepatic2): 20 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for cardiac index | cardiac index | Phase 7(neohepatic3): 1 hour after reperfusion | 
| comparison of invasive and non-invasive measurement for systemic vascular resistance | systemic vascular resistance measured by the following equation: SVR=(Mean arterial pressure-central venous pressure)*80/cardiac output. Femoral MAP is used for the invasive measurement | Phase 7(neohepatic3): 1 hour after reperfusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline) | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 4 (anhepatic 2): 10 minutes after IVC clamping | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 6(neohepatic2): 20 minutes after reperfusion | 
| comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure | systolic and diastolic blood pressure | Phase 7(neohepatic3): 1 hour after reperfusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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finger cuff, systemic vascular resistance, cardiac index, noninvasive monitoring