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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020368
Receipt No. R000023126
Scientific Title Study on assistant algorism of intraoperative neurophysiological monitoring (Prospective study)
Date of disclosure of the study information 2016/03/25
Last modified on 2018/07/17

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Basic information
Public title Study on assistant algorism of intraoperative neurophysiological monitoring (Prospective study)
Acronym Prospective study on intraoperative neurophysiological monitoring
Scientific Title Study on assistant algorism of intraoperative neurophysiological monitoring (Prospective study)
Scientific Title:Acronym Prospective study on intraoperative neurophysiological monitoring
Region
Japan

Condition
Condition Cases conducted intraoperative neurophysiological monitoring (IONM) for motor function
Classification by specialty
Orthopedics Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To improve accuracy of IONM by correcting the amplitude of motor evoked potential (MEP) with vital signs etc.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Detection accuracy (sensitivity and specificity) of postoperative paraplegia
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases conducted IONM for motor function in cardiosurgery and orthopedics
Key exclusion criteria Cases without responses of motor evoked potential due to strong paralysis before surgery.
Data which is not sufficient quality to analysis because of missing-value or noise etc.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimitoshi Nishiwaki
Organization Nagoya University Graduate School of Medicine
Division of Clinical Medicine
Biomedical Regulation
Division name Anesthesiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2340
Email nishi@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Fujii
Organization Nagoya University Graduate School of Medicine Division of Clinical Medicine Biomedical Regulation
Division name Anesthesiology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2340
Homepage URL
Email plus9@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Graduate School of Engineering
Department of Information and Communication Engineering
Institute
Department

Funding Source
Organization Applying
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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 25 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
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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analyzing data collecting from EHR, anesthesia record, vital sign monitor and neural function measuring system.

[Study design]
Secondary analysis

[Subscription for eligible patient]
The data conducted intraoperative neurophysiological monitoring for motor function of cardiovascular surgery or orthopedic surgery with agreement by patient and without paralysis before surgery in date of approval for study through March 2018

[Collecting items]
<EMR>
Disease, procedure, age, gender, height, weight, summary of in hospital, report of medical image
<Patient monitor or anesthesia record>
Waveform and numeric data of ECG, BP, temperature, SpO2, respiration, CO2, plethysmogram, BIS, NIRS, anesthesia record, anamnesis of neurological disease, incident of paralysis
<Neural function measuring system>
Patient information without personal information, condition of measurement, MEP and other EPs, EMG, EEG, event data

Management information
Registered date
2015 Year 12 Month 27 Day
Last modified on
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023126

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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