UMIN-CTR Clinical Trial

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
Email	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
Email	payashi77@hotmail.com

Sponsor
Institute	Department of Anesthesiology, Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019653