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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026029
Receipt No. R000029918
Scientific Title Consideration of left-right difference of phrenic nerve conduction time
Date of disclosure of the study information 2017/03/01
Last modified on 2019/02/09

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Basic information
Public title Consideration of left-right difference of phrenic nerve conduction time
Acronym Consideration of left-right difference of phrenic nerve conduction time
Scientific Title Consideration of left-right difference of phrenic nerve conduction time
Scientific Title:Acronym Consideration of left-right difference of phrenic nerve conduction time
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measured the phrenic nerve conduction time of healthy subjects and examined the presence or absence of left and right difference, normal value, and wanted to use it for the diagnosis of phrenic paralysis.
Basic objectives2 Others
Basic objectives -Others The phrenic nerve anatomically passes through different routes on the right and left, and the lengths are not the same on the left and right.In case of phrenic nerve paralysis (or injury), delay of nerve conduction time conduction blockade occurs. In order to diagnose the presence or absence of delay in conduction time, there is a method to compare with the healthy side, but when the right and left nerve conduction time normal values are different, it can not be compared with the healthy side. We measured the phrenic nerve conduction time of healthy subjects and examined the presence or absence of left and right difference, normal value, and wanted to use it for the diagnosis of phrenic paralysis.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Phrenic nerve conduction time (Only once)
Key secondary outcomes age
height
body weight

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 A phrenic nerve conduction test is performed on the subject. The electrode for recording is placed on the xiphoid process, the indifferent electrode is placed on the transition portion of the 8 th intercostal osteochondral, and the stimulation electrode is percutaneously stimulated behind the neck sternocleidomastoid muscle. Measure the conduction time of the phrenic nerve and compare the left and right phrenic nerve.
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
40 years-old >
Gender Male
Key inclusion criteria 1. Working staff or student under training
2. A healthy person who can acquire the consent of research participation by voluntary intention from the person himself / herself
Key exclusion criteria Persons who have a history of respiratory disease or cardiovascular disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimi Katayama
Organization Okayama University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 2-5-1 Shikada cho Kita-ku, Okayama-city
TEL 086-235-7752
Email yoshimikatayama@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimi Katayama
Organization Okayama University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 2-5-1 Shikada cho Kita-ku, Okayama-city
TEL 086-235-7752
Homepage URL
Email yoshimikatayama@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation Medicine, Okayama University Hospital
Institute
Department

Funding Source
Organization Department of Rehabilitation Medicine, Okayama University Hospital
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
Address
Tel
Email

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
2017 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2017 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029918

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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