UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030151 |
|---|---|
| Receipt number | R000034438 |
| Scientific Title | The development and utility verfication of new needle guide for safe ultrasound guided central venous catherization (simulation study) |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/11/30 13:29:06 |
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Basic information
Public title
The development and utility verfication of new needle guide for safe ultrasound guided central venous catherization (simulation study)
Acronym
The development of new needle guide for ultrasound guided central venous catherization
Scientific Title
The development and utility verfication of new needle guide for safe ultrasound guided central venous catherization (simulation study)
Scientific Title:Acronym
The development of new needle guide for ultrasound guided central venous catherization
Region
| Japan |
Condition
Condition
Central venous catherization
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compare commercial needle guide and free-hands with new needle guide by using a CVC simulator.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
successful rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and 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
New needle guide
Interventions/Control_2
Commercial needle guide
Interventions/Control_3
Free-hands
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A junior resident who does not experienced in ultrasound-guided central venous catheterization with a needle guide.
Key exclusion criteria
A junior resident 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 | Joho |
| Middle name | |
| Last name | Tokumine |
Organization
Kyorin University school of medicine
Division name
Department of Anesthesiology
Zip code
181-8611
Address
Mitaka city Shinkawa 6-20-2, Tokyo, Japan
TEL
0422-47-5511
kunitarowatanabe@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kunitaro |
| Middle name | |
| Last name | Watanabe |
Organization
Kyorin University school of medicine
Division name
anesthesiology
Zip code
1818611
Address
Mitaka city Shinkawa 6-20-2, Tokyo Japan
TEL
0422-47-5511
Homepage URL
kunitarowatanabe@yahoo.co.jp
Sponsor or person
Institute
Kyorin university school of medicine department of anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Kyorin university school of medicine department of anesthesiology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine
Address
Mitaka city Shinkawa 6-20-2, Tokyo, Japan
Tel
0422475511
kunitarowatanabe@yahoo.co.jp
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
35
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
| 2017 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034438
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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