UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022355 |
|---|---|
| Receipt number | R000025771 |
| Scientific Title | The development using EEG for prediction of delirium |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2020/12/14 15:53:50 |
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Basic information
Public title
The development using EEG for prediction of delirium
Acronym
The development using EEG for prediction of delirium
Scientific Title
The development using EEG for prediction of delirium
Scientific Title:Acronym
The development using EEG for prediction of delirium
Region
| Japan |
Condition
Condition
complete resection of esoghageal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prediction using EEG for the incidence of delirium
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Can we predict the incidence of delirium to use EEG?
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who agree this intervention
Key exclusion criteria
no consciousness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Miho |
| Middle name | |
| Last name | Miyajima |
Organization
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences
Division name
Section of Liaison Psychiatry and Palliative Medicine
Zip code
1138519
Address
1-5-45 Yushima, Tokyo, Japan
TEL
03-5803-5859
miholppm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Miho Miyajima |
Organization
Tokyo Medical and Dental University
Division name
Section of Liaison Psychiatry and Palliative Medicine
Zip code
1138519
Address
1-5-45 Yushima, Tokyo, Japan
TEL
03-5803-5859
Homepage URL
miholppm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Section of Liaison Psychiatry and Palliative Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Department of anesthesiology
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
Tokyo Medical and Dental University Review Board
Address
1-5-45 Yushima, Tokyo, Japan
Tel
03-5803-4085
info.bec@tmd.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
東京医科歯科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | 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
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2016 | Year | 05 | Month | 19 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025771
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
