UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010936 |
|---|---|
| Receipt number | R000010080 |
| Scientific Title | The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form) |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2018/12/26 17:13:37 |
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Basic information
Public title
The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Acronym
The effect of vasoconstriction agent for FloTrac system
Scientific Title
The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Scientific Title:Acronym
The effect of vasoconstriction agent for FloTrac system
Region
| Japan |
Condition
Condition
Elective surgery patient over 20 yrs
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to estimate the difference of measurements between objective device (FloTrac system) and control device (Ordinary cardiac output monitoring devices).
Basic objectives2
Others
Basic objectives -Others
Estimation of the accuracy of medical used device.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of cardiac output measurements between FloTrac system and Ordinary cardiac output monitoring devices in anesthesia.
Key secondary outcomes
The existence of cardiac output measurements change in FloTrac system and Ordinary cardiac output monitoring devices in anesthesia.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Planned arterial catheterization.
Planned usage of vasoconstriction agent if necessary.
Pulmonary artery catheter and/or transesophageal ultrasonic cardiography planned.
Written informed consent
Key exclusion criteria
Diagnosis of moderate or severe arterial regargitation.(Except the patients who are expected to be corrected aortic regurgitation during surgery.)
Treated by intra aortic baloon pumping.
Pregnant woman.
Body mass index more than 40.
Body weight less than 40kg.
Participation to other studies which influence the measurements of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Kawamoto |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
081-082-256-3234
r-nacamura@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryuji Nakamura |
Organization
Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
Address
1-2-3,Kasumi,Minami-ku,Hiroshima
TEL
081-082-256-3234
Homepage URL
r-nacamura@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2013 | Year | 06 | Month | 12 | Day |
Last modified on
| 2018 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010080
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
