UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016930 |
|---|---|
| Receipt number | R000019653 |
| Scientific Title | Evaluation of laser speckle flowgraphy during cardiovascular surgery with selective cerebral perfusion to monitor cerebral perfusion |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2021/03/31 18:20:36 |
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Basic information
Public title
Evaluation of laser speckle flowgraphy during cardiovascular surgery with selective cerebral perfusion to monitor cerebral perfusion
Acronym
Evaluation of laser speckle flowgraphy during cardiovascular surgery with selective cerebral perfusion to monitor cerebral perfusion
Scientific Title
Evaluation of laser speckle flowgraphy during cardiovascular surgery with selective cerebral perfusion to monitor cerebral perfusion
Scientific Title:Acronym
Evaluation of laser speckle flowgraphy during cardiovascular surgery with selective cerebral perfusion to monitor cerebral perfusion
Region
| Japan |
Condition
Condition
Aortic arch aneurysm, Aortic arch dissection, Coronary artery desease, Vulve desease
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the applicability of measurement of ocular circulation using laser speckle flowgraphy for monitoring of cerebral perfusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association with minimum value of ocular circulation using laser speckle flowgraphy and postoperative cerebral complication
Key secondary outcomes
Incidence of postoperative cerebral and ophthalmological complication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Laser speckle flowgraphy is used for monitoring of cerebral perfusion during cardiovascular surgery.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiovascular surgery with cardiopulmonary bypass
Key exclusion criteria
Severer cataract
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Hayashi |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
payashi77@hotmail.com
Public contact
Name of contact person
| 1st name | Hironobu |
| Middle name | |
| Last name | Hayashi |
Organization
Nara Medical University
Division name
Anesthesiology
Zip code
634-8522
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
payashi77@hotmail.com
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo, Kashihara, Nara, Japan
Tel
0744-22-3051
payashi77@hotmail.com
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
| 2015 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Intraoperative motor evoked potential significantly decreased when the ocular blood flow by LSFG decreased to 30% of the control after carotid artery clamping during carotid endarterectomy.
By measurement of the arterial component of the optic nerve head blood flow, a more accurate cerebral perfusion state can be known.
Results date posted
| 2019 | Year | 09 | Month | 27 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
In recent years, treatment for aortic aneurysm and aortic dissection has been changed to endovascular treatment (stent placement), and the number of aortic arch replacement, which is the subject of this study, has decreased.
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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 29 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019653
| 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 |
