UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026199 |
|---|---|
| Receipt number | 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 16:43:00 |
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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
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
t-k-s-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030099
