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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.
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/SvO2â„¢; Edward Lifesciences LLC, Irvine, CA, USA) is placed. This is connected to the Vigilanceâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clearsight (finger cuff) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clearsight (finger cuff) | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seong Mi Yang | Contact | +82-10-7300-6282 | seongmi.yang@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Seong Mi Yang | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17033479 | Background | 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. | |
| 26052376 | Background | 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. |
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|
| 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 |
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 |
| 20218415 | Background | 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. |
| 32475686 | Background | 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. |
| 25596280 | Background | 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. |
| 24637618 | Background | 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. |
| 20616408 | Background | 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. |
| 32404245 | Background | 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. |
| 30904953 | Background | 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. |
| 29367620 | Background | 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. |
| 12578081 | Background | 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. |
| 23479677 | Background | 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. |