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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041243
Receipt No. R000047095
Scientific Title Development of anesthesia management robot that deeply learns signs of upper airway obstruction and diagnosis/procedure data of anesthesiologist
Date of disclosure of the study information 2020/07/29
Last modified on 2020/07/29

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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
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 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
2020 Year 07 Month 29 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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