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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026199
Receipt No. R000030099
Scientific Title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Date of disclosure of the study information 2017/02/17
Last modified on 2017/08/22

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Basic information
Public title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Acronym An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Scientific Title An investigation about novel technique of ultrasound-guided internal jugular vein puncture combines short-axis approach and long-axis approach (simulator study).
Scientific Title:Acronym 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
1st name
Middle name
Last name Kei Nishiyama
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code
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
1st name
Middle name
Last name Jun Takeshita
Organization National Hospital Organization Kyoto Medical Center
Division name Department of Emergency and Critical Care Medicine
Zip code
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)

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
2017 Year 02 Month 17 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 Main results already published
Date of protocol fixation
2015 Year 07 Month 21 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000030099

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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