UMIN-CTR Clinical Trial

Basic information
Public title	Anatomical relationship of the vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter in children
Acronym	Vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter
Scientific Title	Anatomical relationship of the vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter in children
Scientific Title:Acronym	Vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter
Region	Japan

Condition
Condition	Surgical Patients
Classification by specialty	Oral surgery Operative medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate anatomical relationship of the vertebral arteries and internal jugular vein during ultrasound-guided cannulation of central venous catheter in children.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Anatomical relationship of the vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter in children and Adults
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Eligibility
Age-lower limit	0 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Surgical patients who need central venous catherter for medical condition
Key exclusion criteria	Cases without positive pressure ventilation by endotracheal intubation, Cases who could not be stretch the neck because of limited motion of the neck, cases who could not identified vertebral artery by using ultrasonography.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Sumio Hoka
Organization	Kyushu University Hospital
Division name	Anesthesia and CCM
Zip code
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5714
Email	shoka@kuaccm.med.kyushu-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ken Yamaura
Organization	Kyushu University Hospital
Division name	Anesthesia and CCM
Zip code
Address	Maidashi 3-1-1, Higashi-ku, Fukuoka 812-8582, Japan
TEL	092-642-5714
Homepage URL
Email	keny@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University Hospital
Institute
Department

Funding Source
Organization	Kyushu University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	2012 Year 09 Month 08 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date	2012 Year 06 Month 08 Day
Last follow-up date
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Date trial data considered complete
Date analysis concluded

Other

Other related information

Linear probe (13-6MHz) of S-Nerve manufactured by Sonosite was used and blood vessels were visualized from body surface using the B-mode. Image of the right common carotid artery (CCA), right internal jugular vein (IJV) and right vertebral artery (VA) were recorded. To identify the vertebral artery, it was confirmed that the vertebral artery branched from the right subclavian artery using with Color Doppler method. Each size, anatomical relationship, the shortest distance between IJV nad VA are measured and statistilcally analyzed.

Management information
Registered date	2012 Year 09 Month 05 Day
Last modified on	2013 Year 09 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010397

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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