Tokyo, Sept. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059000) titled 'Correlation between Forehead and Mandibular Placement of the Patient State Index Sensor' on Sept. 5.
Study Type:
Observational
Primary Sponsor:
Institute - Hitachi, Ltd.
Condition:
Condition - Diseases requiring surgery
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
Eligibility:
Age-lower limit - 20
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 Size - 40
Recruitment Status:
Recruitment status - Preinitiation
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067476
Disclaimer: Curated by HT Syndication.
