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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024559
Receipt No. R000028265
Scientific Title A study on utility of electromagnetic needle guidance system for ultrasound-guided central venous catheterization
Date of disclosure of the study information 2016/12/01
Last modified on 2018/10/28

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Basic information
Public title A study on utility of electromagnetic needle guidance system for ultrasound-guided central venous catheterization
Acronym A study on utility of electromagnetic needle guidance for CVC
Scientific Title A study on utility of electromagnetic needle guidance system for ultrasound-guided central venous catheterization
Scientific Title:Acronym A study on utility of electromagnetic needle guidance for CVC
Region
Japan

Condition
Condition simulation study
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate whether electromagnetic needle guidance system offers some advantage over the conventional mechanical needle guidance system.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The success rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Not using needle guidance system
Interventions/Control_2 Electromagnetic needle guidance system
Interventions/Control_3 Conventional mechanical needle guidance system
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
24 years-old <=
Age-upper limit
50 years-old >=
Gender Male and Female
Key inclusion criteria A junior resident and medical student who does not experienced in ultrasound-guided central venous catheterization with a needle guide.
Key exclusion criteria A junior resident and medical student who experienced in ultrasound-guided central venous catheterization with a needle guide.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunitaro Watanabe
Organization Kyorin University school of medicine
Division name anesthesiology
Zip code
Address Mitaka city Shinkawa 6-20-2, Tokyo, Japan
TEL 0422-47-5511
Email kunitarowatanabe@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunitaro Watanabe
Organization Kyorin University school of medicine
Division name anesthesiology
Zip code
Address Mitaka city Shinkawa 6-20-2, Tokyo Japan
TEL 0422-47-5511
Homepage URL
Email kunitarowatanabe@yahoo.co.jp

Sponsor
Institute Kyorin University school of medicine
Institute
Department

Funding Source
Organization Termo corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2016 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 25 Day
Last modified on
2018 Year 10 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028265

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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