Living Donor Liver TransplantationNCT04909645
A Comparison of Invasive and Non-invasive Measurement of CI and SVR in Liver Transplantation
A study testing Clearsight (finger cuff) in people with Living Donor Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Living Donor Liver Transplantation
- What is being tested?
- Clearsight (finger cuff)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 May 2021to 28 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Seong Mi Yang, 82-10-7300-6282, seongmi.yang@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Living Donor Liver Transplantation
- Being tested
- Clearsight (finger cuff)
- Keywords
- finger cuff, systemic vascular resistance, cardiac index, noninvasive monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Clearsight (finger cuff) | Experimental | Not described Receives: Diagnostic Test: Clearsight (finger cuff) |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 4 (anhepatic 2): 10 minutes after IVC clamping
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 6(neohepatic2): 20 minutes after reperfusion
comparison of invasive and non-invasive measurement for cardiac index
cardiac index
Measured: 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
Measured: Phase 7(neohepatic3): 1 hour after reperfusion
Secondary outcomes (7)
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
systolic and diastolic blood pressure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Phase 7(neohepatic3): 1 hour after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start31 May 2021
- Primary completion28 May 2022 (estimated)
- Study completion28 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Living Donor Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seong Mi Yang, Seoul National University Hospital
- Investigators
- Seong Mi Yang, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909645
- Sponsor's protocol ID
- 2104-037-1209
- Status last verified
- Mar 2022
- First submitted
- 10 May 2021
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17033479Rudnick 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.
PubMed 26052376Evans 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.
PubMed 20218415Saugel 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.
PubMed 32475686Saugel 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.
PubMed 25596280Kim 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.
PubMed 24637618Al-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.
PubMed 20616408Kanazawa 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.
PubMed 32404245Sumiyoshi 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.
PubMed 30904953Lee 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.
PubMed 29367620Critchley 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.
PubMed 12578081Suehiro 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.
PubMed 23479677
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Invasive and Non-invasive Measurement of Cardiac Index and Systemic Vascular Resistance in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT04909645
- Acronym / sponsor ID
- 2104-037-1209
- Conditions
- Living Donor Liver Transplantation
- Keywords
- finger cuff, systemic vascular resistance, cardiac index, noninvasive monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 28 May 2022 (estimated)
- Study completion
- 28 May 2022 (estimated)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clearsight (finger cuff) | Experimental | Diagnostic Test: Clearsight (finger cuff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Clearsight (finger cuff) |
Primary outcome
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 4 (anhepatic 2): 10 minutes after IVC clamping
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 4 (anhepatic 2): 10 minutes after IVC clamping
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 6(neohepatic2): 20 minutes after reperfusion
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 6(neohepatic2): 20 minutes after reperfusion
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
comparison of invasive and non-invasive measurement for cardiac index
Time frame: Phase 7(neohepatic3): 1 hour after reperfusion
cardiac index
comparison of invasive and non-invasive measurement for systemic vascular resistance
Time frame: Phase 7(neohepatic3): 1 hour after reperfusion
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
7 secondary outcomes
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 2 (preanhepatic2): 60 minutes after the anesthetic induction
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 3 (anhepatic 1): 10 minutes after recipient hepatectomy is complete
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 4 (anhepatic 2): 10 minutes after IVC clamping
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 5 (neohepatic1 [reperfusion]): 5 minutes after reperfusion
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 6(neohepatic2): 20 minutes after reperfusion
comparison of invasive and non-invasive measurement for systolic and diastolic blood pressure
Time frame: Phase 7(neohepatic3): 1 hour after reperfusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 17033479De 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.
- Background: PubMed 26052376Rudnick 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.
- Background: PubMed 20218415Evans 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.
- Background: PubMed 32475686Saugel 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.
- Background: PubMed 25596280Saugel 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.
- Background: PubMed 24637618Kim 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.
- Background: PubMed 20616408Al-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.
- Background: PubMed 32404245Kanazawa 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.
- Background: PubMed 30904953Sumiyoshi 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.
- Background: PubMed 29367620Lee 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.
- Background: PubMed 12578081Critchley 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.
- Background: PubMed 23479677Suehiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seong Mi Yang principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearsight (finger cuff) in people with Living Donor Liver Transplantation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seong Mi Yang (+82-10-7300-6282, seongmi.yang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of invasive and non-invasive measurement for cardiac index (time frame: Phase 1 (preanhepatic1): completion of the anesthetic induction (baseline)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909645, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.