UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Consideration of left-right difference of phrenic nerve conduction time
Title of the study (Brief title)	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	Yoshimi Katayama
Organization	Okayama University Hospital
Division name	Department of Rehabilitation Medicine
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	Yoshimi Katayama
Organization	Okayama University Hospital
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029918