UMIN-CTR Clinical Trial

Basic information
Public title	Development of anesthesia management robot that deeply learns signs of upper airway obstruction and diagnosis/procedure data of anesthesiologist
Acronym	Development of anesthesia management robot
Scientific Title	Development of anesthesia management robot that deeply learns signs of upper airway obstruction and diagnosis/procedure data of anesthesiologist
Scientific Title:Acronym	Development of anesthesia management robot
Region	Japan

Condition
Condition	dentistry
Classification by specialty	Anesthesiology Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main purpose of this study is to digitize quantifiable items from various physiological functions that regulate the respiratory function during sedation into large-scale data, and use AI (artificial intelligence) to determine the severity of anesthesiologist illness. It is to develop an anesthesia management robot equipped with a new AI respiration monitor by performing deep learning using the judgment of the degree and the treatment of airway maintenance as teacher data.
Basic objectives2	Others
Basic objectives -Others	Sedation and non-intubation intravenous anesthesia have been applied in cases such as minor surgical operations/procedures, examinations, and dental treatments, but because they are managed under spontaneous breathing, there is always a risk of upper airway obstruction. is there. During sedation, respiratory management is performed by performing continuous measurements such as transcutaneous oxygen saturation, but the current condition is that no early signs of upper airway obstruction can be detected, and oxygen saturation is below 90%. After it began to decline, hypoxemia worsened suddenly, and in cases where the anesthesiologist was not involved in systemic management, it became a clinically extremely dangerous condition, such as delays in the airway maintenance of medical personnel. Could be. Therefore, it is necessary to detect the signs of upper airway obstruction early and generalize the diagnosis and treatment by anesthesiologists.
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Item 1: Waveform data of airflow limitation during inspiration and expiration obtained with a nasal mask Item 2: Carbon dioxide data by capnograph with nasal cannula Item 3: Movement data of forehead, temporal region, chin, chest, and abdomen using an acceleration sensor Item 4: Percutaneous arterial oxygen saturation data Item 5: Depth of anesthesia data by BIS monitor and EMG activity Item 6 (Teacher data): Anesthesiologist's determination of upper airway obstruction during sedation and treatment data are created in advance by selective formation, and comments and correspondence are leveled.
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
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Interventions/Control_5
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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	Twenty adult healthy volunteers (volunteers) who agreed with the explanation of the content of the research plan are targeted.
Key exclusion criteria	1)Patients with serious respiratory illness 2) Patients with serious cardiovascular disease 3)Diabetes patients with poor control 4)Severe renal disorder patient 5)Severe liver disorder patient 6)Patients who have hypersensitivity (allergy) to the drug to be used 7)Patients who are judged to be unsuitable by the research supervisor or the co-workers
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Ayuse
Organization	Nagasaki University
Division name	Dental Anesthesiology
Zip code	8528588
Address	Sakamoto Nagasaki Jpan
TEL	81958197713
Email	ayuse@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Ayuse
Organization	Nagasaki University Hospital
Division name	Dental Anesthesiology
Zip code	81958197713
Address	Sakamoto Nagasaki Jpan
TEL	81958197713
Homepage URL
Email	ayuse@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nagasaki university
Address	Sakamoto Nagasaki Jpan
Tel	0958197714
Email	ayuse@nagasaki-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	長崎県

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 29 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	2020 Year 06 Month 16 Day
Date of IRB	2020 Year 07 Month 29 Day
Anticipated trial start date	2020 Year 08 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	NONE

Management information
Registered date	2020 Year 07 Month 29 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047095