UMIN-CTR Clinical Trial

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