UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008857 |
|---|---|
| Receipt number | R000010397 |
| Scientific Title | Anatomical relationship of the vertebral artery and internal jugular vein during ultrasound-guided cannulation of central venous catheter in children |
| Date of disclosure of the study information | 2012/09/08 |
| Last modified on | 2013/09/05 10:56:23 |
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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
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
| 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
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
keny@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
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
Address
Tel
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
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
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
Date of closure to data entry
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
Value
https://center6.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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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
