UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041569
Receipt number R000045033
Scientific Title Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation
Date of disclosure of the study information 2020/08/27
Last modified on 2020/08/27 05:50:11

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Basic information

Public title

Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation

Acronym

Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation

Scientific Title

Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation

Scientific Title:Acronym

Variation in the axillary brachial plexus detected via ultrasonography and nerve stimulation

Region

Japan


Condition

Condition

volunteer

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

There are few reports that researched anatomical variation of brachial plexus using both ultrasonography and a pen-type nerve stimulator via skin. On the other hand, most of previous references reported either left or right side of brachial plexus anatomically due to orthopedic operations. Therefore, we originally compared the difference between both sides of nerve positions for each case.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The mean and standard deviation value of each nerve angle (left and right) was evaluated and the difference between left and right would be shown in Figure .

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

HEALTY ADULTS VOLUNTEERS

Key exclusion criteria

DIFFICULT TO UNDERSTAND JAPANESE

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, Medical Center East

Division name

ANESTHESIOLOGY

Zip code

116-8567

Address

2-1-10 Nishi-ogu ARAKAWAKU TOKYO

TEL

+81338101111

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, Medical Center East

Division name

ANESTHESIOLOGY

Zip code

116-8567

Address

2-1-10 Nishi-ogu ARAKAWAKU TOKYO

TEL

+81338101111

Homepage URL


Email

kmkodaka@cb3.so-net.ne.jp


Sponsor or person

Institute

TOKYO WOMEN'S MEDICAL CENTER EAST

Institute

Department

Personal name



Funding Source

Organization

TOKYO WOMEN'S MEDICAL CENTER EAST

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, Medical Center East

Address

2-1-10 Nishi-ogu AKAKAWAKU TOKYO

Tel

+81338101111

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 08 Month 27 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

36

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

2017 Year 03 Month 01 Day

Date of IRB

2017 Year 03 Month 01 Day

Anticipated trial start date

2017 Year 03 Month 01 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observatory trial


Management information

Registered date

2020 Year 08 Month 27 Day

Last modified on

2020 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name