UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of Real-Time Physiologic Data in ICU Patients through Application of Video-Based Image Processing Programs
Acronym	Analysis of Real-Time Physiologic Data in ICU Patients through Application of Video-Based Image Processing Programs
Scientific Title	Analysis of Real-Time Physiologic Data in ICU Patients through Application of Video-Based Image Processing Programs
Scientific Title:Acronym	Analysis of Real-Time Physiologic Data in ICU Patients through Application of Video-Based Image Processing Programs
Region	Japan

Condition
Condition	ICU patients
Classification by specialty	Intensive care medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of physiologic data through video image
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between physiological changes and image changes
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	all patients in ICU
Key exclusion criteria	patients without consent
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Hidenobu Middle name Last name Shigemitsu
Organization	Tokyo Medical and Dental University
Division name	Department of Intensive Care Medicine
Zip code	113-08510
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5652
Email	hshiccm@tmd.ac.jp

Public contact
Name of contact person	1st name Hideo Middle name Last name Yamanouchi
Organization	Tokyo Medical and Dental University
Division name	Department of Advanced Systems Modeling in Intensive Care Medicine
Zip code	113-1519
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03-5803-5959
Homepage URL
Email	yamanouchi.ccm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Sony Imaging Products & Solutions Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Ethics Committee, Tokyo Medical and Dental University
Address	1-5-45 Yushima Bunkyo-ku Tokyo
Tel	03-3813-6111
Email	shomu1.adm@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

Other administrative information
Date of disclosure of the study information	2020 Year 10 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 10 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	Observational study on connecting between physiologic data and video image in ICU patients

Management information
Registered date	2020 Year 08 Month 21 Day
Last modified on	2020 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047346

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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