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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009245
Receipt No. R000010848
Scientific Title An investigation of venous wall tenting by the needle during ultrasound-guided internal jugular vein cannulation
Date of disclosure of the study information 2012/11/01
Last modified on 2014/12/01

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Basic information
Public title An investigation of venous wall tenting by the needle during ultrasound-guided internal jugular vein cannulation
Acronym An investigation of venous wall tenting by the needle during ultrasound-guided internal jugular vein cannulation
Scientific Title An investigation of venous wall tenting by the needle during ultrasound-guided internal jugular vein cannulation
Scientific Title:Acronym An investigation of venous wall tenting by the needle during ultrasound-guided internal jugular vein cannulation
Region
Japan

Condition
Condition Patients who underwent general anesthesia and internal jugular vein cannulation, and whose ultrasound image was recorded
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Posterior venous wall penetration during internal jugular vein cannulation can cause inadvertent injuries of artery and nerve posteriorly positioned to the vein. Ultrasound image reveals that a needle compresses the vein, and tents the anterior venous wall during cannulation. In this research, we are going to investigate whether posterior venous wall penetration would be associated to the venous diameter, and the venous tenting.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate whether the venous diameter and other factors including venous wall tenting would be associated to posterior venous wall penetration
Key secondary outcomes To seek factors related to the venous wall tenting

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent general anesthesia and internal jugular vein cannulation, and whose ultrasound longitudinal image was recorded
Key exclusion criteria Patients who underwent general anesthesia and internal jugular vein cannulation, but whose ultrasound longitudinal image was not recorded
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hitoshi YOSHIDA
Organization Hirosaki University Graduate School of Medicine
Division name Emergncy and Disaster Medicine
Zip code
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-33-5111
Email hiyoshida-hki@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hitoshi Yoshida
Organization Hirosaki University Graduate School of Medicine
Division name Emergncy and Disaster Medicine
Zip code
Address 5 Zaifu-cho, Hirosaki, Aomori
TEL 0172-33-5111
Homepage URL
Email hiyoshida-hki@umin.ac.jp

Sponsor
Institute Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization Dept of Anesthesiology AND Dept of Emergency and Disaster Medicine, Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Hirosaki Chuo Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s00540-014-1937-0
Number of participants that the trial has enrolled
Results
Eleven cannulations in 56 patients were assigned to posterior venous wall penetration. Small venous diameter (P=0.004), and long anterior venous wall tenting (P=0.007) were associated with posterior venous wall penetration. The longer anterior venous tenting would be expected with reducing needle angle (P=0.004) or increasing anterior venous wall thickness (P=0.006).
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 13 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2012 Year 12 Month 07 Day
Date of closure to data entry
2012 Year 12 Month 07 Day
Date trial data considered complete
2013 Year 01 Month 31 Day
Date analysis concluded
2013 Year 01 Month 31 Day

Other
Other related information The following investigations will be done; to evaluate whether the venous diameter and other factors including venous wall tenting would be associated to posterior venous wall penetration, and to seek factors related to the venous wall tenting, which will be compared with it in simulators.

Management information
Registered date
2012 Year 11 Month 01 Day
Last modified on
2014 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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