UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059415 |
|---|---|
| Receipt number | R000067953 |
| Scientific Title | Prospective Observational Study on the Clinical Utility of AI-based Facial Detection in the Pediatric Intensive Care Unit |
| Date of disclosure of the study information | 2025/10/16 |
| Last modified on | 2025/10/15 11:21:00 |
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Basic information
Public title
Prospective Observational Study on the Clinical Utility of AI-based Facial Detection in the Pediatric Intensive Care Unit
Acronym
Prospective Observational Study on the Clinical Utility of AI-based Facial Detection in the Pediatric Intensive Care Unit
Scientific Title
Prospective Observational Study on the Clinical Utility of AI-based Facial Detection in the Pediatric Intensive Care Unit
Scientific Title:Acronym
FIND-PICU Study Facial Identification using AI for Non-invasive monitoring in the Department of PICU
Region
| Japan |
Condition
Condition
All pediatric critical illnesses requiring intensive care
Classification by specialty
| Pediatrics | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate and compare the facial detection performance of the Google Vision API and a custom convolutional neural network (CNN) model using images captured in pediatric intensive care settings.
Detection success rates and bounding box localization accuracy (e.g., IoU) will be compared, considering real-world clinical conditions such as lighting variability, patient positioning, and presence of medical devices. This will inform future development of real-time AI applications in clinical monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of AI-based facial detection in camera-captured images
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
| 1 | days-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All photo of patients in PICU are included
Key exclusion criteria
none
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Wataru |
| Middle name | |
| Last name | Sakai |
Organization
Hokkaido Child Health and Rehabilitation Center
Division name
PICU
Zip code
060-0035
Address
1-1-240-6 Kanayama, Teine-ku, Sapporo, Hokkaido 006-0041, Japan
TEL
0116915696
sakaiwataru1128@gmail.com
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Sakai |
Organization
Sapporo Medical University of Medicine
Division name
Department of Anesthesiology
Zip code
006-0041
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido
TEL
0116915696
Homepage URL
https://kodomo.hospital.pref.hokkaido.lg.jp/department/kenkyubumon/
sakaiwataru1128@gmail.com
Sponsor or person
Institute
Hokkaido Child Health and Rehabilitation Center
Institute
Department
Personal name
Wataru Sakai
Funding Source
Organization
The Hokkaido Foundation for the Advancement of Science and Technology (Noastec Foundation)
Shinohara Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Medical Center for Child Health and Rehabilitation
Address
6, 1, 240, 1 Chome, 1Jyo, Kanayama, Teine, Sapporo, Hokkaido
Tel
0116915696
sakaiwataru1128@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
北海道
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067953
