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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036436
Receipt No. R000041517
Scientific Title Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Date of disclosure of the study information 2019/05/01
Last modified on 2019/06/13

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Basic information
Public title Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Acronym Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Scientific Title Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Scientific Title:Acronym Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Region
Japan

Condition
Condition cardiovascular surgery
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Can we predict the onset of delirium in the intensive care unit using bedside physiological monitoring?
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Can we predict the onset of delirium in the intensive care unit using bedside physiological monitoring?
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Open-heart surgery and major vessel surgery
Key exclusion criteria History of mental illness
Patients with dementia
Unconscious
The person in charge of research judged it to be inappropriate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Maiko
Middle name
Last name Satomoto
Organization Toho University
Division name Anesthesiology
Zip code 1438541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Email maiko.satomoto@med.toho-u.ac.jp

Public contact
Name of contact person
1st name Maiko
Middle name
Last name Satomoto
Organization Toho University
Division name Research consultation desk
Zip code 1438541
Address 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 0337624151
Homepage URL
Email maiko.satomoto@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Toho University
Address Ota-ku
Tel 0337624161
Email maiko.satomoto@med.toho-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
2019 Year 05 Month 01 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 Enrolling by invitation
Date of protocol fixation
2021 Year 02 Month 01 Day
Date of IRB
2019 Year 02 Month 01 Day
Anticipated trial start date
2021 Year 05 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Analysis data (sample) protects personal information by deleting identifiable personal information (anonymization). In anonymization, random numbering is performed in Excel to create a correspondence table. Also, all information files are used with a password, and the stored USB and paper media information is also stored in a locker locker and not used on PCs that can connect to the Internet environment. Analysis data after the end of the study is stored by a research executor in a locker that takes 10 years.

Management information
Registered date
2019 Year 04 Month 07 Day
Last modified on
2019 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041517

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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