UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on utility of electromagnetic needle guidance system for ultrasound-guided central venous catheterization
Title of the study (Brief title)	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	Kunitaro Watanabe
Organization	Kyorin University school of medicine
Division name	anesthesiology
Address	Mitaka city Shinkawa 6-20-2, Tokyo, Japan
TEL	0422-47-5511
Email	kunitarowatanabe@yahoo.co.jp

Public contact
Name of contact person	Kunitaro Watanabe
Organization	Kyorin University school of medicine
Division name	anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028265