UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047549 |
|---|---|
| Receipt number | R000054226 |
| Scientific Title | Research on the construction of an automatic control system for general anesthesia applying artificial intelligence |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2022/04/21 16:19:32 |
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Basic information
Public title
Research on the construction of an automatic control system for general anesthesia applying artificial intelligence
Acronym
Research on the construction of an automatic control system for general anesthesia applying artificial intelligence
Scientific Title
Research on the construction of an automatic control system for general anesthesia applying artificial intelligence
Scientific Title:Acronym
Research on the construction of an automatic control system for general anesthesia applying artificial intelligence
Region
| Japan |
Condition
Condition
Adult patients undergoing non-cardiac surgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Applying machine learning of artificial intelligence, we will build an automatic control system for general anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a) Patient information (height, weight, age, complications)
b) Vital signs (mean blood pressure, heart rate, SpO2, EtCO2, body temperature, BIS value)
c) Patient information (height, weight, age, complications)
d) Dosage of various anesthetics (sevoflurane, desflurane, propofol, remifentanil, fentanyl, rocuronium, sugammadex)
e) Intraoperative drugs (ephedrine, atropine sulfate, neocinedin, perdipine, adrenaline, steroids)
f) Infusion information (infusion volume, blood transfusion volume, urine volume)
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing non-cardiac surgery under general anesthesia
Key exclusion criteria
(1) Patients under 20 years old
(2) Cardiac surgery patients
(3) Patients with serious complications
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hoshijima |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Dento-oral Anesthesiology
Zip code
980-8575
Address
Seiryomachi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8420
hhoshi6@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hoshijima |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Dento-oral Anesthesiology
Zip code
980-8575
Address
Seiryomachi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-8420
Homepage URL
hhoshi6@gmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry,Division of Dento-oral Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Dentistry, Division of Dento-oral Anesthesiology
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
Tohoku University Graduate School of Dentistry
Address
Seiryomachi 4-1, Aoba, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8420
hhoshi6@gmail.com
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
| 2023 | Year | 01 | 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
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect perioperative management records of adult non-cardiac surgery performed under general anesthesia at our hospital from electronic medical records, anesthesia charts, and nursing records.
The collected data is replaced with a CSV file and analyzed by artificial intelligence. 40,000 patients are set in the training set to build an initial prototype model for the construction of an automatic anesthesia control system, and 10,000 patients are set in the test set to validate the model.
Management information
Registered date
| 2022 | Year | 04 | Month | 21 | Day |
Last modified on
| 2022 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
