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

NCT04909645 | Unknown DMC

• 1 other identifier: 2104-037-1209
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Living Donor Liver Transplantation

Keywords

finger cuff; systemic vascular resistance; cardiac index; noninvasive monitoring

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (7)

• comparison of invasive and non-invasive measurement for 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

  Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction

• comparison of invasive and non-invasive measurement for 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

  Phase 4 (anhepatic 2): 10 minutes after IVC clamping

• comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure

  Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion

Study Arms (1)

Clearsight (finger cuff)

EXPERIMENTAL

Diagnostic Test: Clearsight (finger cuff)

Interventions

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.

Clearsight (finger cuff)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (12)

• 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.

  PMID: 17033479 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.

  PMID: 26052376 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.

  PMID: 20218415 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.

  PMID: 32475686 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.

  PMID: 25596280 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.

  PMID: 24637618 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.

  PMID: 20616408 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.

  PMID: 32404245 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.

  PMID: 30904953 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.

  PMID: 29367620 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.

  PMID: 12578081 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.

  PMID: 23479677 BACKGROUND

Study Officials

• Seong Mi Yang

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seong Mi Yang

CONTACT

+82-10-7300-6282; seongmi.yang@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 2, 2021
• Study Start: May 31, 2021
• Primary Completion: May 28, 2022
• Study Completion: May 28, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)