UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058164 |
|---|---|
| Receipt number | R000066479 |
| Scientific Title | The anatomical study of the venous access sites for peripheral inserted central catheterization in Japanese healthy volunteers: a single center study |
| Date of disclosure of the study information | 2025/06/13 |
| Last modified on | 2025/06/12 14:39:29 |
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Basic information
Public title
The anatomical study of the venous access sites for peripheral inserted central catheterization in Japanese healthy volunteers: a single center study
Acronym
The anatomical study of the venous access sites for PICC in Japanese healthy volunteers: a single center study
Scientific Title
The anatomical study of the venous access sites for peripheral inserted central catheterization in Japanese healthy volunteers: a single center study
Scientific Title:Acronym
The anatomical study of the venous access sites for PICC in Japanese healthy volunteers: a single center study
Region
| Japan |
Condition
Condition
Japanese healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The venous access sites for peripheral inserted central catheterization and midline catheter are selected in the order of basilic vein, brachial vein, and cephalic vein. However, there has not been certain anatomical data about these vein in Japanese. The purpose of this study is to acquire the depth from the skin and the diameter of these veins in healthy volunteers
Basic objectives2
Others
Basic objectives -Others
The other purpose is to facilitate the transition to new study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The medial upper arm is divided by three zones. The primary outcome is the venous diameters of basilic vein, brachial vein and cephalic vein in the distal portion, the middle portion and the proximal portion.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Anesthesiologists, nurses working in the operating room, clinical engineers, residents training in the department of anesthesiology
Key exclusion criteria
Individuals requested to opt out of this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Ami |
| Middle name | |
| Last name | Namba |
Organization
Sapporo Medical University
Division name
Research Support Section of Administrative Office
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
rinri@sapmed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Research Support Section of Administrative Office
Address
S1, W16, Chuo-ku, Sapporo
Tel
011-611-2111
rinri@sapmed.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
| 2025 | Year | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We provide the information about the study in advance via e-mail and our website. Also, for medical students, we provide the information about this study using the printed materials displayed in the Department of Anesthesiology office and operating room.
Management information
Registered date
| 2025 | Year | 06 | Month | 12 | Day |
Last modified on
| 2025 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066479
