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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039646
Receipt No. 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

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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
Email 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
Email kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute TOKYO WOMEN'S MEDICAL UNIVERISTY
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044774

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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