UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017760 |
|---|---|
| Receipt number | R000020493 |
| Scientific Title | Study of influence factors that affects the brain oxygen saturation during open-heart surgery |
| Date of disclosure of the study information | 2015/06/02 |
| Last modified on | 2018/11/27 08:40:06 |
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Basic information
Public title
Study of influence factors that affects the brain oxygen saturation during open-heart surgery
Acronym
Study of influence factors that affects the brain oxygen saturation during open-heart surgery
Scientific Title
Study of influence factors that affects the brain oxygen saturation during open-heart surgery
Scientific Title:Acronym
Study of influence factors that affects the brain oxygen saturation during open-heart surgery
Region
| Japan |
Condition
Condition
adult patients undergoing open-heart surgery
Classification by specialty
| Cardiovascular surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we designed a study using near-infrared spectroscopy and visible spectroscopy to assess how skin blood flow or hemodilution influences brain oxygen saturation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain oxygen saturation, skin oxygen saturation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the brain oxygen saturation monitor
NIRO-200NX
Interventions/Control_2
the brain oxygen saturation monitor
INVOS5100C
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
adult patients undergoing open-heart surgery in Juntendo University Hospital
Key exclusion criteria
patient with cerebrovascular disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsushita |
Organization
Juntendo University Faculty of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
saty-m@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Matsushita |
Organization
Juntendo University Faculty of Medicine
Division name
Cardiovascular Surgery
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
saty-m@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University, Faculty of Medicine, Department of Cardiovascular Surgery
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020493
