UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020368
Receipt number 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 2020/02/03 17:12:06

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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 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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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