UMIN-CTR Clinical Trial

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 Kimitoshi Middle name Last name Nishiwaki
Organization	Nagoya University Graduate School of Medicine Division of Clinical Medicine Biomedical Regulation
Division name	Anesthesiology
Zip code	466-8560
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 Tasuku Middle name Last name Fujii
Organization	Nagoya University Graduate School of Medicine Division of Clinical Medicine Biomedical Regulation
Division name	Anesthesiology
Zip code	466-8560
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	N/A
Address	N/A
Tel	N/A
Email	N/A

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	N/A (The study was terminated.)
Publication of results	Unpublished

Result
URL related to results and publications	N/A (The study was terminated.)
Number of participants that the trial has enrolled	0
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	Terminated
Date of protocol fixation	2015 Year 12 Month 25 Day
Date of IRB	2015 Year 12 Month 25 Day
Anticipated trial start date	2016 Year 03 Month 25 Day
Last follow-up date	2020 Year 02 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study had been terminated before starting. We did not submit IRB application but the date of IRB is the same as the date of protocol fixation because empty of the date of IRB did not allowed. 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	2020 Year 02 Month 03 Day

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