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Trial registered on ANZCTR


Registration number
ACTRN12611000171910
Ethics application status
Approved
Date submitted
10/02/2011
Date registered
14/02/2011
Date last updated
14/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac output derived from arterial pressure waveform analysis: validation of the third-generation software in patients undergoing orthotopic liver transplantation
Scientific title
Cardiac output derived from arterial pressure waveform analysis: validation of the third-generation software in patients undergoing orthotopic liver transplantation
Secondary ID [1] 253584 0
Institutional Review Board of Chang Gung Memorial Hospital
No. 98-3015B
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recipients scheduled for orthotopic liver transplantation 261144 0
Condition category
Condition code
Anaesthesiology 259300 259300 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cardiac output measurments by a Swan-Ganz catheter (pulmonary artery catheter) is gold standard method in present despite its reported inaccuracies and drawbacks. The alternative tool, FloTrac/Vigileo system (arterial pressure waveform analysis), has the advantage of being inherently less invasive. This is an observational study intraoperatively to evaluate the upgraded third-generation software (version 3.02) for the FloTrac/Vigileo system. This latest version has been developed to particularly improve the accuracy of cardiac output measurements in hyperdynamic conditions. The aim of our prospective study was to compare the cardiac output values obtained using the FloTrac/Vigileo system during orthotopic liver transplantation with those obtained in the same circumstances using a Swan-Ganz catheter (bolus thermodilution method) within 6 months period.
Intervention code [1] 258011 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262106 0
Accuracy of the upgraded third-generation software (version 3.02) for the FloTrac/Vigileo system
For statistical analysis, we will use the linear regression, Bland-Altman analysis, bias, 95% limits of agreement, and percentage error between COTh and COFT measurements for analysis.
Timepoint [1] 262106 0
intraoperative
Secondary outcome [1] 273168 0
Nil
Timepoint [1] 273168 0
Nil

Eligibility
Key inclusion criteria
consecutive recipients scheduled for orthotopic liver transplantation
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were preoperative dysrhythmias, significant valvular pathology and severe arterial occlusion disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3175 0
Taiwan, Province Of China
State/province [1] 3175 0
Taiwan

Funding & Sponsors
Funding source category [1] 258476 0
Hospital
Name [1] 258476 0
Department of Anaesthesiology, Chang Gung Memorial Hospital
Address [1] 258476 0
5 Fu-Shin Street, Kwei-Shan Tao-Yuan, Taiwan 333
Country [1] 258476 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Department of Anaesthesiology, Chang Gung Memorial Hospital
Address
5 Fu-Shin Street, Kwei-Shan Tao-Yuan, Taiwan 333
Country
Taiwan, Province Of China
Secondary sponsor category [1] 257617 0
None
Name [1] 257617 0
Address [1] 257617 0
Country [1] 257617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260452 0
Institutional Review Board of Chang Gung Memorial Hospital
Ethics committee address [1] 260452 0
5 Fu-Shin Street, Kwei-Shan Tao-Yuan, Taiwan 333
Ethics committee country [1] 260452 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 260452 0
14/10/2009
Approval date [1] 260452 0
19/11/2009
Ethics approval number [1] 260452 0
98-3015B

Summary
Brief summary
The FloTrac/Vigileo software was upgraded to version 3.0+ in 2008 to improve the inaccurate cardiac output measurments in hyperdynamic conditions. More patients were recruited to develop the algorithm database than were used for the second-generation software, including more patients with hyperdynamic conditions. If this system really is interchangeable with the gold standard bolus thermodilution method that requires PAC catheterization, it may decrease fatal complications in those recipients who are fragile and immunocompromised during the surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32197 0
Address 32197 0
Country 32197 0
Phone 32197 0
Fax 32197 0
Email 32197 0
Contact person for public queries
Name 15444 0
Yung-Fong Tsai
Address 15444 0
5 Fu-Shin Street, Kwei-Shan Tao-Yuan, Taiwan 333
Country 15444 0
Taiwan, Province Of China
Phone 15444 0
011-886-3-3281200 ext.2324
Fax 15444 0
011-886-3-3281200 ext.2787
Email 15444 0
yungfongt@gmail.com
Contact person for scientific queries
Name 6372 0
Yung-Fong Tsai
Address 6372 0
5 Fu-Shin Street, Kwei-Shan Tao-Yuan, Taiwan 333
Country 6372 0
Taiwan, Province Of China
Phone 6372 0
011-886-3-3281200 ext.2324
Fax 6372 0
011-886-3-3281200 ext.2787
Email 6372 0
yungfongt@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary