UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000034259
Receipt No. 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 (Ver. 4)

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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
Email 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
Email h.kanda0629@nifty.com

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039060