UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059000 |
|---|---|
| Receipt number | R000067476 |
| Scientific Title | Correlation between Forehead and Mandibular Placement of the Patient State Index Sensor |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/10/20 14:46:17 |
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Basic information
Public title
Correlation between Forehead and Mandibular Placement of the Patient State Index Sensor
Acronym
Correlation between Mandibular and Forehead Patient State Index Sensors
Scientific Title
Correlation between Forehead and Mandibular Placement of the Patient State Index Sensor
Scientific Title:Acronym
Correlation between Mandibular and Forehead Patient State Index Sensors
Region
| Japan |
Condition
Condition
Diseases requiring surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between Patient State Index (PSI) values obtained from sensors placed on the mandible and the forehead during general anesthesia, and to clarify the potential utility of the mandible as an alternative monitoring site.
Basic objectives2
Others
Basic objectives -Others
To analyze the differences in Patient State Index (PSI) values between mandible and forehead placement, and to assess the clinical feasibility of mandible placement as a monitoring site.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation coefficient between Patient State Index (PSI) values obtained from sensors placed on the mandible and the forehead
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients scheduled for surgery under general anesthesia
Patients who provide informed consent for the placement of PSI sensors
Key exclusion criteria
Patients under 20 years of age
Patients with skin conditions or trauma that make PSI sensor placement difficult
Patients with neurological disorders or severe cognitive impairment that could affect assessment
Patients who do not provide informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Yaguchi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
3170077
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
TEL
0294231111
takuya.shiraishi.fw@hitachi.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Shiraishi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
3170077
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
TEL
09025579046
Homepage URL
tshiraishi.1217@gmail.com
Sponsor or person
Institute
Hitachi, Ltd.
Institute
Department
Personal name
Funding Source
Organization
NA
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
Hitachi General Hospital
Address
2-1-1 Jonan-cho, Hitachi, Ibaraki 317-0077, Japan
Tel
0294231111
takuya.shiraishi.fw@hitachi.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
| 2025 | Year | 09 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 09 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067476
