UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044971 |
|---|---|
| Receipt number | R000045783 |
| Scientific Title | Problems and improvement of the catheter insertion under ultrasound guidance using the central venous simulator. |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2024/01/28 17:15:32 |
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Basic information
Public title
Problems and improvement of the catheter insertion under ultrasound guidance using the central venous simulator.
Acronym
Problems and improvement of the catheter insertion under ultrasound guidance using the central venous simulator.
Scientific Title
Problems and improvement of the catheter insertion under ultrasound guidance using the central venous simulator.
Scientific Title:Acronym
Problems and improvement of the catheter insertion under ultrasound guidance using the central venous simulator.
Region
| Japan |
Condition
Condition
Anesthesiologist and resident
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to recognize the outbreak of complications such as blood vessel rear wall puncture or the deviation of the guidewire visually under ultrasound guidance using the central venous simulator.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Problems and refinement to be provided by recognizing it visually
Key secondary outcomes
Correspondence effect and problems such as shortening a needle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate and observe the outbreak of complications such as the rear wall puncture, using a record of an ultrasound image and a picture of the blood vessel lumen at the time of the puncture.
Interventions/Control_2
To evaluate the similar examination using a change of the length of the needle.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anesthesiologist or resident doctor who is belong to Kumamoto university hospital or related hospital of Kumamoto university.
Key exclusion criteria
No agreement
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ikuta |
Organization
Kumamoto University Hospital
Division name
Surgical center
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, JAPAN
TEL
096-373-7125
yoshiiku@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Ikuta |
Organization
Kumamoto University Hospital
Division name
Surgical center
Zip code
860-8556
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, JAPAN
TEL
096-373-7125
Homepage URL
yoshiiku@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
None
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
Faculty of Life Science Kumamoto University
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, JAPAN
Tel
096-373-5657
ski-shien@jimu.kumamoto-u.ac.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
| 2021 | Year | 08 | 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
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
| 2020 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045783
