UMIN-CTR Clinical Trial

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

Cases conducted intraoperative neurophysiological monitoring (IONM) for motor function

Classification by specialty

Orthopedics	Anesthesiology	Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Detection accuracy (sensitivity and specificity) of postoperative paraplegia

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Applying

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

名古屋大学医学部附属病院（愛知県）

Date of disclosure of the study information

2016

Year

03

Month

25

Day

URL releasing protocol

N/A (The study was terminated.)

Publication of results

Unpublished

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

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 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

Registered date

2015

Year

12

Month

27

Day

Last modified on

2020

Year

02

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023126