UMIN-CTR Clinical Trial

Basic information
Public title	Development of vital signs prediction model using artificial intelligence:Supporting clinical decision.
Acronym	Development of vital signs prediction model using artificial intelligence:Supporting clinical decision.
Scientific Title	Creating a model to support clinical decision by predicting intraoperative vital signs using artificial Intelligence
Scientific Title:Acronym	Creating a model to support clinical decision by predicting intraoperative vital signs using artificial Intelligence
Region	Japan

Condition
Condition	Patient for operation under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To create a simulation model to predict intraoperative vital signs, and to validate and evaluate the model.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative vital signs: systolic blood pressure, mean blood pressure, diastolic blood pressure, heart rate.
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	150 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent surgery under the anesthesiologist in the operating room of Kansai Rosai Hospital from July 2011
Key exclusion criteria	If the patient or the patient's guardian refuses to participate in the research. Patients who are judged inappropriate by the principal investigator
Target sample size	40000

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Ueyama
Organization	Kansai Rosai Hospital
Division name	Department of Anesthesiology
Zip code	660-8511
Address	3-1-69, Inabasou,Amagasaki,Hyougo,Japan
TEL	06-6416-1221
Email	ueyama-hiroshi@kansaih.johas.go.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Ueyama
Organization	Kansai Rosai Hospital
Division name	Department of Anesthesiology
Zip code	660-8511
Address	3-1-69, Inabasou,Amagasaki,Hyougo,Japan
TEL	06-6416-1221
Homepage URL
Email	ueyama-hiroshi@kansaih.johas.go.jp

Sponsor
Institute	Kansai Rosai Hospital
Institute
Department

Funding Source
Organization	Philips Japan, LTD.
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	Ethics Committee, Kansai Rosai Hospital
Address	3-1-69, Inabasou,Amagasaki,Hyougo,Japan
Tel	06-6416-1221
Email	postmaster@kansaih.johas.go.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	2021 Year 07 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	2021 Year 03 Month 05 Day
Date of IRB	2021 Year 03 Month 05 Day
Anticipated trial start date	2021 Year 07 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	Verifying the accuracy of AI-based predictions of vital signs using validation data.

Management information
Registered date	2021 Year 06 Month 25 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050967