UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039646 |
|---|---|
| Receipt number | R000044774 |
| Scientific Title | Evaluating the risk of radial nerve injury during radial cutaneous venous puncture and anatomical relationship between medial cubital vein and superficial radial nerve using ultrasound and nerve stimulation in volunteers |
| Date of disclosure of the study information | 2020/02/29 |
| Last modified on | 2020/08/24 12:23:21 |
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Basic information
Public title
Evaluating the risk of radial nerve injury during radial cutaneous venous puncture and anatomical relationship between medial cubital vein and superficial radial nerve using ultrasound and nerve stimulation in volunteers
Acronym
Evaluating the risk of radial nerve injury during radial cutaneous venous puncture and anatomical relationship between medial cubital vein and superficial radial nerve using ultrasound and nerve stimulation in volunteers
Scientific Title
Evaluating the risk of radial nerve injury during radial cutaneous venous puncture and anatomical relationship between medial cubital vein and superficial radial nerve using ultrasound and nerve stimulation in volunteers
Scientific Title:Acronym
Evaluating the risk of radial nerve injury during radial cutaneous venous puncture and anatomical relationship between medial cubital vein and superficial radial nerve using ultrasound and nerve stimulation in volunteers
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Previous studies report that radial venous punctures within 12-cm proximal to the radial styloid process should be avoided because of radial nerve damage. However, the related anatomical researches were performed using cadavers, which sometimes sustained damage to the superficial nerves during dissection. We investigated the intersection points between the superficial branches of the radial nerve using portable ultrasound and a pen-type cutaneous nerve stimulator, in volunteers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We investigated the intersection points between the superficial branches of the radial nerve using portable ultrasound and a pen-type cutaneous nerve stimulator, in volunteers.
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
healthy volunteer
Key exclusion criteria
Nothing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | MITSUHARU |
| Middle name | |
| Last name | KODAKA |
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
Division name
ANESTHESIOLOGY
Zip code
1628666
Address
8-1 KAWADACYO SHINJYUKU TOKYO
TEL
0333538112
kmkodaka@cb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | MITSUHARU |
| Middle name | |
| Last name | KODAKA |
Organization
TOKYO WOMEN'S MEDICAL UNIVERSITY
Division name
ANESTHESIOLOGY
Zip code
1628666
Address
8-1 KAWADACYO SHINJYUKU TOKYO
TEL
09022047740
Homepage URL
kmkodaka@cb3.so-net.ne.jp
Sponsor or person
Institute
TOKYO WOMEN'S MEDICAL UNIVERISTY
Institute
Department
Personal name
Funding Source
Organization
TOKYO WOMEN'S MEDICAL UNIVERISTY
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
TOKYO WOMEN'S MEDICAL UNIVERSITY
Address
8-1 KAWADACYO SHINJYUKU TOKYO
Tel
0300538112
kmkodaka@cb3.so-net.ne.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
4679
Org. issuing International ID_1
TOKYO WOMEN'S MEDICAL UNIVERSITY
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
32
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special information
Management information
Registered date
| 2020 | Year | 02 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044774
