UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061752 |
|---|---|
| Receipt number | R000070667 |
| Scientific Title | Validation of Core Body Temperature Measurement at the Inguinal Region Using a Core Body Temperature Sensor (Moni-Patch) |
| Date of disclosure of the study information | 2026/06/05 |
| Last modified on | 2026/06/04 12:41:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Validation of Core Body Temperature Measurement at the Inguinal Region Using a Core Body Temperature Sensor (Moni-Patch)
Acronym
Validation of Inguinal Core Body Temperature Measurement via Moni-Patch
Scientific Title
Validation of Core Body Temperature Measurement at the Inguinal Region Using a Core Body Temperature Sensor (Moni-Patch)
Scientific Title:Acronym
Validation of Inguinal Core Body Temperature Measurement via Moni-Patch
Region
| Japan |
Condition
Condition
Patients undergoing non-cardiac surgery under general anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Neurosurgery | Plastic surgery | Operative medicine |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the clinical utility of a wearable core body temperature sensor (Moni-Patch) attached to the inguinal region (over the femoral artery) in patients undergoing general anesthesia. The core body temperature measured at the inguinal region will be compared and correlated with that measured at the neck (over the common carotid artery) from the induction of anesthesia. After the initiation of standard monitoring (bladder or esophageal temperature), the correlations among inguinal, neck, and standard core body temperatures will be validated. Additionally, this study will analyze the impact of subcutaneous tissue thickness (the distance from the skin to the artery) at the measurement sites on the accuracy of the temperature readings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in measured body temperature (absolute values and mean errors) between the sensor attached to the neck and the sensor attached to the inguinal region. * Differences in measured body temperature (absolute values and mean errors) between the sensor attached to the inguinal region and bladder/esophageal temperature. * Chronological changes in body temperature measured at the three distinct sites (inguinal region, neck, and bladder or esophagus).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 years or older.
2.Patients undergoing non-cardiac surgery under general anesthesia.
3.Patients scheduled for core body temperature monitoring (esophageal or bladder temperature) for 180 minutes or longer during general anesthesia.
4.Patients (or their legally acceptable representatives) who provide written informed
Key exclusion criteria
1.Patients undergoing (or likely to undergo) surgery or procedures at the neck or inguinal region.
2.Patients with anatomical abnormalities, infections, or severe wounds on the skin of the neck or inguinal region.
3.Patients in surgical positions that prevent the attachment of temperature sensors to the neck or inguinal region.
4.Patients with a history of contact dermatitis or hypersensitivity to medical adhesive tapes.
5.Patients otherwise judged inappropriate for participation by the principal or sub-investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | HIROTAKA |
| Middle name | |
| Last name | OKUDA |
Organization
Department of Anesthesiology, St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
h2okuda@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROTAKA |
| Middle name | |
| Last name | OKUDA |
Organization
Department of Anesthesiology, St. Marianna University School of Medicine
Division name
Department of Anesthesiology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
TEL
044-977-8111
Homepage URL
h2okuda@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee, St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan
Tel
044-977-8111
rinsho-kenkyu@marianna-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Relationship with Standard Care (Exclusion of Intervention)
The data collected via the wearable temperature sensor (Moni-Patch) and ultrasound measurement of subcutaneous tissue thickness are exclusively for research purposes. These measurements will not be used for intraoperative patient management or clinical decision-making (e.g., initiating or stopping active warming) by the anesthesiologists. All intraoperative thermal management will be guided solely by standard clinical indicators (bladder or esophageal temperature).
2. Independence of Data Management and Analysis
Although this study is funded by Murata Manufacturing Co., Ltd., the collection, management, and statistical analysis of the data will be conducted independently by the research team at the Department of Anesthesiology, St. Marianna University School of Medicine. The funding company will have no involvement in data manipulation or the interpretation of the results.
Management information
Registered date
| 2026 | Year | 05 | Month | 31 | Day |
Last modified on
| 2026 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070667
