UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041496 |
|---|---|
| Receipt number | R000047346 |
| Scientific Title | Analysis of Real-Time Physiologic Data in ICU Patients through Application of Video-Based Image Processing Programs |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2023/02/22 09:29:34 |
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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 | Hideo |
| Middle name | |
| Last name | Yamanouchi |
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
yamanouchi.ccm@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 Intensive Care Medicine
Zip code
113-1519
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
03-5803-5959
Homepage URL
yamanouchi.ccm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Sony Corporation
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
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
17
Results
In the present study, we examined whether there was a correlation between vital signs and video features such as anguished facial expressions and body movements in patients who became critically ill during the imaging process, with a time lag, but no significant results were obtained. Further study of more cases may reveal whether or not video features are useful as a leading indicator of changes in vital signs or sudden changes in patients.
Results date posted
| 2021 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients admitted to the ICU
Participant flow
The camera is used to take pictures of patients for whom consent has been obtained.
Adverse events
no
Outcome measures
To determine if there is a correlation between values obtained from facial expressions and body movements and vital signs.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047346
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
