UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044725
Receipt number R000051084
Scientific Title Using machine learning to create a system for predicting blood pressure decline from thermographic images during anesthesia induction
Date of disclosure of the study information 2021/07/02
Last modified on 2021/07/01 14:12:22

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Basic information

Public title

Using machine learning to create a system for predicting blood pressure decline from thermographic images during anesthesia induction

Acronym

Using machine learning to create a system for predicting blood pressure decline from thermographic images during anesthesia induction

Scientific Title

Using machine learning to create a system for predicting blood pressure decline from thermographic images during anesthesia induction

Scientific Title:Acronym

Using machine learning to create a system for predicting blood pressure decline from thermographic images during anesthesia induction

Region

Japan


Condition

Condition

Elective surgery patients

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to create a classifier (system) that can discriminate cases where blood pressure drops during induction of anesthesia from thermographic images at the time of entering the operating room using an image analysis system and machine learning.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Create a classifier (system) that can discriminate between drops in blood pressure, create a receiver operating characteristic curve, and determine sensitivity and specificity.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing elective surgery at Yamagata University Hospital

Key exclusion criteria

Cardiac surgery
Patients with predicted peripheral circulatory blood flow disturbances

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Misato
Middle name
Last name Kurota

Organization

Yamagata University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code

9909585

Address

2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan

TEL

023-628-5400

Email

patsykurota224@gmail.com


Public contact

Name of contact person

1st name Misato
Middle name
Last name Kurota

Organization

Yamagata University Faculty of Medicine

Division name

Department of Anesthesiology

Zip code

9909585

Address

2-2-2 Iida-nishi, Yamagata city, Yamagata, Japan

TEL

023-628-5400

Homepage URL


Email

patsykurota224@gmail.com


Sponsor or person

Institute

Yamagata University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Yamagata University Faculty of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The Ethical Review Committee of Yamagata University Faculty of Medicine

Address

2-2-2, Iida-nishi, yamagata-shi, Yamagata Japan

Tel

0236285015

Email

ikekenkyu@jm.kj.yamagata-u.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

2021 Year 07 Month 02 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 06 Month 01 Day

Date of IRB

2021 Year 06 Month 28 Day

Anticipated trial start date

2021 Year 07 Month 05 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

An anesthesiologist will administer anesthesia as usual and record the degree of hypotension. Before entering the operating room, a frontal photograph of the patient and thermographic images of both hands are taken. Machine learning is performed and a classifier is created as supervised learning. After that, a receiver operating characteristic curve is created, and sensitivity and specificity are obtained.


Management information

Registered date

2021 Year 07 Month 01 Day

Last modified on

2021 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051084


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name