UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026029 |
|---|---|
| Receipt number | 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 09:07:50 |
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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
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
yoshimikatayama@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029918
