UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of change of optic nerve sheath diameter during cardiovascular surgery
Acronym	ECOCAS
Scientific Title	Evaluation of change of optic nerve sheath diameter during cardiovascular surgery
Scientific Title:Acronym	ECOCAS
Region	Japan

Condition
Condition	Cardiac valve disease or aortic arch disease
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Monitoring of cerebral circulation using optic nerve sheath diameter measured by ultrasound
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of optic nerve sheath diameter
Key secondary outcomes	Association between postoperative cerebral disfunction and change of optic nerve sheath diameter

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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	A ultrasound (iE33, Philips, Netherlands) with linear transducer (11 to 7MHz) was used intraoperatively for measurement of optic nerve sheath diameter (ONSD). Measurement of ONSD were performed at 3 points as follows; 1 after induction of anesthesia, 2 during cardiopulmonary bypass, 3 after cardiopulmonary bypass. It takes several tens of seconds for each measurement.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing cardiovascular surgery with cardiopulmonary bypass
Key exclusion criteria	No disturbance of consciousness before surgery, Severer visual dysfunction
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Ogawa
Organization	Nara Medical University
Division name	Anesthesiology
Zip code	6348521
Address	840 Shijo, Kashihara, Nara, Japan
TEL	0744-22-3051
Email	yvljohbxb0219@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Ogawa
Organization	Nara Medical University
Division name	Anesthesiology
Zip code	6348521
Address	840 Shijo, Kashihara, Nara, Japan
TEL	0744-22-3051
Homepage URL
Email	yvljohbxb0219@gmail.com

Sponsor
Institute	Department of Anesthesiology, Nara Medical University
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Nara Medical University
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	Nara Medical University
Address	840 Shijo, Kashihara, Nara, Japan
Tel	0744-22-3051
Email	yvljohbxb0219@gmail.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 12 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Suspended
Date of protocol fixation	2015 Year 08 Month 17 Day
Date of IRB	2015 Year 07 Month 03 Day
Anticipated trial start date	2015 Year 09 Month 13 Day
Last follow-up date	2019 Year 09 Month 13 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 12 Month 14 Day
Last modified on	2021 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023195