UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012732 |
|---|---|
| Receipt number | R000014279 |
| Scientific Title | Validation of cardiac output measurement using 4th generation Vigileo-FloTrac system in cardiac surgery |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2015/01/04 23:28:20 |
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Basic information
Public title
Validation of cardiac output measurement using 4th generation Vigileo-FloTrac system in cardiac surgery
Acronym
Validation of cardiac output measurement using 4th generation Vigileo-FloTrac system in cardiac surgery
Scientific Title
Validation of cardiac output measurement using 4th generation Vigileo-FloTrac system in cardiac surgery
Scientific Title:Acronym
Validation of cardiac output measurement using 4th generation Vigileo-FloTrac system in cardiac surgery
Region
| Japan |
Condition
Condition
Cardiac Disease
Greater Vessel Disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy of cardiac output measurement with 4th generation Vigileo-Flotrac system in cardiovascular surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac output values derived from 4th generation Vigileo-FloTrac system
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo cardiovascular surgery under general anesthesia
Key exclusion criteria
Patients who have atrial fibrillation or atrial flutter
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
TEL
06-6645-2186
anesth@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuaki Tanaka |
Organization
Osaka City University Graduate School of Medicine
Division name
Anesthesiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586 Japan
TEL
06-6645-2186
Homepage URL
anesth@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jcvaonline.com/article/S1053-0770(14)00346-2/abstract
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Bland and Altman analysis between cardiac output derived from Vigileo-FloTrac system and cardiac output derived from pulmonary arterial catheters
Management information
Registered date
| 2013 | Year | 12 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014279
