UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034259 |
|---|---|
| Receipt number | R000039060 |
| Scientific Title | Evaluation of cerebral circulation during cardiovascular surgery by laser speckle flowgraphy |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2020/03/25 16:19:09 |
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Basic information
Public title
Evaluation of cerebral circulation during cardiovascular surgery by laser speckle flowgraphy
Acronym
Cerebral microcirculation during cardiovascular surgery
Scientific Title
Evaluation of cerebral circulation during cardiovascular surgery by laser speckle flowgraphy
Scientific Title:Acronym
Cerebral microcirculation during cardiovascular surgery
Region
| Japan |
Condition
Condition
cardiovascular surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess ONH blood flow during cardiovascular surgery using LSFG and to evaluate its feasibility and usability as a neuromonitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean blur rate
Key secondary outcomes
hemodynamic parameter
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
| 18 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Scheduled cardiovascular surgery
Key exclusion criteria
Fundus or intracranial vessel diseases, glaucoma, severe cataract, and retinal disease
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Kanda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2583
h.kanda0629@nifty.com
Public contact
Name of contact person
| 1st name | Hirotsugu |
| Middle name | |
| Last name | Hirotsugu Kanda |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL
0166-68-2583
Homepage URL
h.kanda0629@nifty.com
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Young Scientists
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
Tel
0166-68-2297
pikaseika@jimu.asahikawa-med.ac.jp
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
| 2018 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
https://reader.elsevier.com/reader/sd/pii/S000349751831868X?token=8FA4DFD0094D32335726932B95129DDCC0
Publication of results
Published
Result
URL related to results and publications
https://reader.elsevier.com/reader/sd/pii/S000349751831868X?token=8FA4DFD0094D32335726932B95129DDCC0
Number of participants that the trial has enrolled
28
Results
In conclusion, no significant difference was observed in the cerebral circulation between RCP and simple circulatory arrest without adjunctive strategy under moderate hypothermia. In contrast, the cerebral circulation during SCP was significantly higher than simple circulatory arrest and RCP. These results suggest that cerebral microcirculation may not be adequate during RCP compared with SCP under moderate hypothermia.
Results date posted
| 2020 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Consecutive patients who underwent scheduled aorticarch repair for aneurysm
Participant flow
A total of 28 consecutive patients were enrolled. Preopera-tive magnetic resonance imaging and computed tomographic scans indicated atherosclerotic lesions in the internal carotid artery in 3 patients. One patient had change of operative procedure or SCP methods. As a result, 23 patients were analyzed.
Adverse events
none
Outcome measures
In this study, changes in MBR and rSO2 were set as primary outcomes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
LSFG-NAVI was used to evaluate ONH blood flow as a measure of cerebral microcirculation. The details of the underlying principles of LSFG are described elsewhere. Briefly, LSFG allows for noninvasive quantitative and qualitative evaluation of ocular perfusion using the laser speckle phenomenon, which is an interference event observed when coherent light sources are scattered by a diffusing surface. In accordance with the moving erythrocytes in the target area, the structure of the speckle pattern, which appears under the illumination of laser irradiation, varies depending on the blood flow velocity. The mean blur rate (MBR; measured in arbitrary units; AU), calculated from variations in the blurring, is a quantitative index of the relative blood flow velocity. MBR images are acquired continuously at a rate of 30 frames per second for a 4-s time period and transferred to a computer file. The LSFG Analyzer software then synchronizes the captured MBR images for 4 s and averages the MBR over the 4-s duration to produce a color-coded MBR map of the ONH as a qualitative analysis. In addition, the software calculates the mean MBR of each cardiac cycle over 4 s throughout the ONH as a quantitative analysis. Data are shown as mean standard division.
Management information
Registered date
| 2018 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039060
