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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Living Donor Liver Transplantation
• Intervention / Treatment: Diagnostic test: Clearsight (finger cuff)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Seong Mi Yang; Phone Number: 82-10-7300-6282; Email: seongmi.yang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clearsight (finger cuff)	Diagnostic test: Clearsight (finger cuff); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Rudnick MR, Marchi LD, Plotkin JS. Hemodynamic monitoring during liver transplantation: A state of the art review. World J Hepatol. 2015 Jun 8;7(10):1302-11. doi: 10.4254/wjh.v7.i10.1302.
• Critchley LA, Critchley JA. A meta-analysis of studies using bias and precision statistics to compare cardiac output measurement techniques. J Clin Monit Comput. 1999 Feb;15(2):85-91. doi: 10.1023/a:1009982611386.
• Sumiyoshi M, Maeda T, Miyazaki E, Hotta N, Sato H, Hamaguchi E, Kanazawa H, Ohnishi Y, Kamei M. Accuracy of the ClearSight system in patients undergoing abdominal aortic aneurysm surgery. J Anesth. 2019 Jun;33(3):364-371. doi: 10.1007/s00540-019-02632-6. Epub 2019 Mar 23.
• Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.
• Saugel B, Cecconi M, Wagner JY, Reuter DA. Noninvasive continuous cardiac output monitoring in perioperative and intensive care medicine. Br J Anaesth. 2015 Apr;114(4):562-75. doi: 10.1093/bja/aeu447. Epub 2015 Jan 16.
• De Wolf AM. 6/2/06 Perioperative assessment of the cardiovascular system in ESLD and transplantation. Int Anesthesiol Clin. 2006 Fall;44(4):59-78. doi: 10.1097/01.aia.0000210818.85287.de. No abstract available.
• Saugel B, Hoppe P, Nicklas JY, Kouz K, Korner A, Hempel JC, Vos JJ, Schon G, Scheeren TWL. Continuous noninvasive pulse wave analysis using finger cuff technologies for arterial blood pressure and cardiac output monitoring in perioperative and intensive care medicine: a systematic review and meta-analysis. Br J Anaesth. 2020 Jul;125(1):25-37. doi: 10.1016/j.bja.2020.03.013. Epub 2020 May 29.
• Kim SH, Lilot M, Sidhu KS, Rinehart J, Yu Z, Canales C, Cannesson M. Accuracy and precision of continuous noninvasive arterial pressure monitoring compared with invasive arterial pressure: a systematic review and meta-analysis. Anesthesiology. 2014 May;120(5):1080-97. doi: 10.1097/ALN.0000000000000226.
• Al-Hamoudi WK. Cardiovascular changes in cirrhosis: pathogenesis and clinical implications. Saudi J Gastroenterol. 2010 Jul-Sep;16(3):145-53. doi: 10.4103/1319-3767.65181.
• Kanazawa H, Maeda T, Miyazaki E, Hotta N, Ito S, Ohnishi Y. Accuracy and Trending Ability of Blood Pressure and Cardiac Index Measured by ClearSight System in Patients With Reduced Ejection Fraction. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3293-3299. doi: 10.1053/j.jvca.2020.03.045. Epub 2020 Apr 20.
• Lee HC, Jung CW. Vital Recorder-a free research tool for automatic recording of high-resolution time-synchronised physiological data from multiple anaesthesia devices. Sci Rep. 2018 Jan 24;8(1):1527. doi: 10.1038/s41598-018-20062-4.
• Suehiro K, Tanaka K, Funao T, Matsuura T, Mori T, Nishikawa K. Systemic vascular resistance has an impact on the reliability of the Vigileo-FloTrac system in measuring cardiac output and tracking cardiac output changes. Br J Anaesth. 2013 Aug;111(2):170-7. doi: 10.1093/bja/aet022. Epub 2013 Mar 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): May 28, 2022
• Study Completion (Anticipated): May 28, 2022

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 2, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: noninvasive monitoring; cardiac index; systemic vascular resistance; finger cuff
• Other Study ID Numbers: 2104-037-1209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No