UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Title of the study (Brief title)	An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Region	Japan

Condition
Condition	none
Classification by specialty	Anesthesiology Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Twenty resident physicians in post-graduate years 1 to 2, perform a simulated, ultrasound-guided internal jugular vein puncture using the short axis , SA , approach and combined short-axis/long-axis, SLA, approaches on manikins. Twenty resident physicians are randomly assigned to two equal groups for performing the manikin study. One group perform punctures using the SA approach followed by SLA; the other perform the same procedures in the opposite order. We compare the two approaches in terms of the success rate and procedure duration; procedural success is defined as the insertion of the guide-wire into the vein while visualizing the needle tip at the time of anterior wall puncture, without penetrating the posterior wall.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Procedural success, which is defined as successful guide-wire insertion without the occurrence of posterior wall puncture and with the needle tip visualized at the time of the anterior wall puncture.
Key secondary outcomes	The duration of the procedure.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	On each group, we defined SLA approach as intervention, and SA approach as control with cross-over method.
Interventions/Control_2	On each group, we defined SLA approach as intervention, and SA approach as control with cross-over method.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Twenty resident physicians in post-graduate years 1 to 2.
Key exclusion criteria	Not applicable
Target sample size	20

Research contact person
Name of lead principal investigator	Kei Nishiyama
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
Address	1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Email	keinishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Jun Takeshita
Organization	National Hospital Organization Kyoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
Address	1-1 Fukakusa, Mukaihata-cho, Fushimi-ku, Kyoto, Japan
TEL	075-641-9161
Homepage URL
Email	t-k-s-t@koto.kpu-m.ac.jp

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 02 Month 17 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 21 Day
Anticipated trial start date	2015 Year 07 Month 30 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 17 Day
Last modified on	2017 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030099