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

Living Donor Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909645
• Other study ID #: 2104-037-1209
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: May 28, 2022

Study information

• Verified date: March 2022
• Source: Seoul National University Hospital
• Contact: Seong Mi Yang
• Phone: +82-10-7300-6282
• Email: seongmi.yang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 28, 2022
• Est. primary completion date: May 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Living Donor Liver Transplantation

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (12)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Saugel B, Hoppe P, Nicklas JY, Kouz K, Körner A, Hempel JC, Vos JJ, Schön 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)
Primary	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)
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction
Primary	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
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete
Primary	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
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 4 (anhepatic 2): 10 minutes after IVC clamping
Primary	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
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion
Primary	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
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 6(neohepatic2): 20 minutes after reperfusion
Primary	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
Primary	comparison of invasive and non-invasive measurement for cardiac index	cardiac index	Phase 7(neohepatic3): 1 hour after reperfusion
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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