A Comparison of Invasive and Non-invasive Measurement of CI and SVR in Liver Transplantation
NCT ID: NCT04909645
Last Updated: 2022-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-05-31
2022-05-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of EV1000™/volumeView™ for Cardiac Output Monitoring in Liver Transplantation
NCT02306018
Comparing Montiroing Cardiac Index by Transpulmonary Thermodilution and Transesophageal Echocardiography During Liver Transplantation
NCT06899867
Hemodynamic Measurements During Liver Transplantation
NCT00682110
Non-Invasive Measurement of SjvO2 Using Near Infrared Spectroscopy in Patients Undergoing Liver Transplantation Surgery
NCT04778150
Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
NCT02717468
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Clearsight (finger cuff)
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Seong Mi Yang
Clinical Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Seong Mi Yang
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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, 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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2104-037-1209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.