UMIN-CTR Clinical Trial

Basic information
Public title	Construction of monitoring camera system for medical use with the function of recogniting the facial imformation.
Acronym	Construction of the medical monitoring camera system.
Scientific Title	Construction of monitoring camera system for medical use with the function of recogniting the facial imformation.
Scientific Title:Acronym	Construction of the medical monitoring camera system.
Region	Japan

Condition
Condition	The patients aged 20 years or older who are entered at the intensive care unit.
Classification by specialty	Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to construct a camera system with the function to automatically evaluate the scale of analgesia or sedation using face information.
Basic objectives2	Others
Basic objectives -Others	Development of camera system with AI Evaluation of the effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary outcome is the correct answers rate of the prediction model which is constructed the machine learning. The correct answer of the prediction model is as follow, RASS, BPS: perfect maching or difference within 1 point. VAS: perfect maching or difference within 10mm. GCS: The maching of the 2 or full items After the second year of research, we will incorporate the data obtained in the previous year into the model, and update the evaluation of the accuracy rate every year.
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 entering the intensive care unit
Key exclusion criteria	Patients who are unable to agree to participate in this study Patients deemed inappropriate as subjects by physicians
Target sample size	1400

Research contact person
Last name of lead principal investigator	1st name shunsuke Middle name Last name Takaki
Organization	Yokohama city university school of medecine
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	2360004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	+81457872800
Email	shunty5323@gmail.com

Public contact
1st name of contact person	1st name Shunsuke Middle name Last name Takaki
Organization	Yokohama city university school of medecine
Division name	Department of Anesthesiology and Critical Care Medicine
Zip code	2360004
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL	+81457872800
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama city university school of medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology Strategic Information and Communications R&D Promotion Programme (SCOPE)
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	The institutional ethics committee of the Yokohama City University Hospital
Address	3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel	+81453707627
Email	rinri@yokohama-cu.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	2022 Year 04 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	2017 Year 12 Month 28 Day
Date of IRB	2017 Year 11 Month 16 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The collection of the data from medical record; patient characterisitics (i.e. height, weight, sex, American society of Anesthesiologists Physical Status, complications [i.e. hyper tension, dibetes, cerebral infarction, dementia, and other neurlogical disease], ope information, and physical findings of head and neck [i.e. intubation, denture, tape, gauze, medical equipment, or tumor]. The facial imformation data is aquired from the bd side medical camera. The sedative or pain scale are evaluted by the nurse who are not related the data analysis. These data are collected at fixed intervals. The data of facial information, sedative or pain scale data, and vitai signs data at the same time are matched. Then these data are used for the machine learning. The the data pairs are collected at 5 to 10 times per day. The cohort of the first year is devoted to data collection for constructing an initial prediction model. From the next year, we will randomly divide into cohorts to construct prediction models and cohorts to confirm the validity of prediction models built up to the previous year. We will improve the prediction model accuracy of artificial intelligence using the data obtained every fiscal year and examine data collection and validity in the following year.

Management information
Registered date	2018 Year 03 Month 30 Day
Last modified on	2019 Year 04 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035399