Physiological Data Analysis of Patients Undergoing Anesthesia for Liver Transplantation

NCT03694301 | Unknown

• 1 other identifier: V107C-209L
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

To record the intra-operative digital data from the standard monitoring instruments containing cardiovascular system information, and from depth-of-anesthesia monitoring modules (Bispectral index, Entropy module, Surgical Plethysmography Index) containing neurological system information captured in the patient monitor, as well as the physiological data regarding anesthetic dosage, respiratory gas analysis and the standard monitoring requirement of anesthesia. All above data comes from patients undergoing liver transplantation surgery for medical reason. The investigators also record the precise time points of detail surgical stages during the surgery . Clinical data collected from these monitoring instrument will be used to gain more understanding of the complex interaction between anesthetic effect, surgical procedure, autonomic response and drug modeling. The goal is to obtain the clinical value of various features extracted from physiological data, in particular the waveform data from cardiovascular system.

Conditions

Liver Transplantation

Keywords

Monitoring, Intraoperative; Pulse Wave Analysis

Outcome Measures

Primary Outcomes (2)

• Correlation between SPI value and heart rate variability at predefined surgical step

  Surgical Pleth Index (SPI) is a newly developed pain monitor derived from analysis of pulse oximetry signal. Such analysis is based on heart rate variability for autonomic nervous system activity. However the accuracy of SPI is questioned for interference of vasculopathy upon pulse oximeter signal quality. For liver transplant, there are three stages as followed: dissection phase, anhepatic phase and neohepatic phase. Liver plays an important role in renin-angiotensin-aldosterone system which affects the vessel tone. Therefore, the investigators will explore the correlation of heart rate variability calculated from ECG QRS complex and SPI at these three different stages in liver transplant. The Spearman rank correlation \> 0.7 and the prediction probability vale \> 0.7 are positive outcome result.

  During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.

• Correlation between Arterial waveform and Flotrac(TM) cardiac output analysis

  Liver plays an important role in renin-angiotensin-aldosterone system which affects vessel tone. At anhepatic phase in liver transplant, it was noticed that the reflected wave in arterial waveform disappears but the forward waveform remains. The investigators hypothesize that this is caused by the inability to transform angiotensinogen without liver. Flotrac by Edward lifescience is a device to calculate cardiac output and stroke volume variation from arterial waveform. The investigators will explore the correlation of Flotrac cardiac output with arterial waveform in anhepatic phase. The arterial waveform analysis includes area under arterial waveform, the slope for forward wave and pulse pressure. Also high dimensional method including diffusion map and locally linear embedding will be used to transform the whole waveform into more meaningful quantitative indices. The Spearman rank correlation \> 0.7 and the prediction probability vale \> 0.7 are positive outcome result.

  During dissection, anhepatic and neohepatic phases. Of IVC clamp, reperfusion, and hepatic artery anatomises, the moment, 10 minutes before, 15 minutes after, 1 hour and 2 hours after the surgical steps.

Secondary Outcomes (1)

• Correlation between waveform analysis, graft and patient survival

  For first week after operation, data will be recorded daily including INR, blood transfusion, serum creatinine and PaO2/Fio2. Kidney and lung injury will be specified. Also the investigators will record days for ICU stay and ventilator use.

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients have been registered or treated in the investigator's hospital as candidates for liver transplantation recipient.

You may qualify if:

• Adult patient undergoing living donor liver transplant with MELD score \< 20

You may not qualify if:

• Vulnerable populations per institutional regulation, including under-age, history of drug abuse, HIV carrier, AIDS, aborigine, prisoner.
• Unable to communicate, for example hepatoencephalopathy, on endotracheal tube with ventilator support
• Complicated liver transplant procedure, for example domino liver donation
• Poor liver graft condition, donor have fatty liver (\>15% adipose tissue by liver biopsy pathologic report)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Duke University: collaborator

Related Publications (2)

• Wang SC, Lin HT, Chang KY, Mandell MS, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Use of higher thromboelastogram transfusion values is not associated with greater blood loss in liver transplant surgery. Liver Transpl. 2012 Oct;18(10):1254-8. doi: 10.1002/lt.23494.

  PMID: 22730210 BACKGROUND

• Wang SC, Teng WN, Chang KY, Susan Mandell M, Ting CK, Chu YC, Loong CC, Chan KH, Tsou MY. Fluid management guided by stroke volume variation failed to decrease the incidence of acute kidney injury, 30-day mortality, and 1-year survival in living donor liver transplant recipients. J Chin Med Assoc. 2012 Dec;75(12):654-9. doi: 10.1016/j.jcma.2012.08.007. Epub 2012 Nov 17.

  PMID: 23245482 BACKGROUND

Study Officials

• Chien-Kun Ting, Dr.

  Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

• Shen-Chih Wang, Dr.

  Department of Anesthesiology, Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

• Hsin-Lin Tsai, Dr.

  Department of Surgery, Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuang-Yi Chang, Dr.

CONTACT

+886-938593159; sufentanil@gmail.com

Chien-Kun Ting, Dr.

CONTACT

+886-938593137; ckting@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 3, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 4, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access will be under the term of use of Dataverse website.