UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019681 |
|---|---|
| Receipt number | R000022570 |
| Scientific Title | Study on assistant algorism of intraoperative neurophysiological monitoring |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2021/01/07 14:20:31 |
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Basic information
Public title
Study on assistant algorism of intraoperative neurophysiological monitoring
Acronym
Retrospective study on intraoperative neurophysiological monitoring
Scientific Title
Study on assistant algorism of intraoperative neurophysiological monitoring
Scientific Title:Acronym
Retrospective 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
Data which is not sufficient quality to analysis because of missing-value or noise etc.
Target sample size
100
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
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2340
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
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2340
Homepage URL
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
Ethics Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel
052-744-2973
ethics@med.nagoya-u.ac.jp
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
| 2015 | Year | 11 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 12 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
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]
All data conducted intraoperative neurophysiological monitoring for motor function of cardiovascular surgery or orthopedic surgery in 2009 through date of approval for study
[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 | 11 | Month | 08 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022570
