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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022355
Receipt No. R000025771
Scientific Title The development using EEG for prediction of delirium
Date of disclosure of the study information 2016/07/20
Last modified on 2018/10/08

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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
Middle name
Last name Miho 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
Address 1-5-45 Yushima, Tokyo, Japan
TEL 03-5803-5859
Email miholppm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Miyajima
Organization Tokyo Medical and Dental University
Division name Section of Liaison Psychiatry and Palliative Medicine
Zip code
Address 1-5-45 Yushima, Tokyo, Japan
TEL 03-5803-5859
Homepage URL
Email miholppm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences, Section of Liaison Psychiatry and Palliative Medicine
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2016 Year 05 Month 19 Day
Last modified on
2018 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025771

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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