Tokyo, June 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061752) titled 'Validation of Core Body Temperature Measurement at the Inguinal Region Using a Core Body Temperature Sensor (Moni-Patch)' on June 5.

Study Type: Observational

Primary Sponsor: Institute - St. Marianna University School of Medicine

Condition: Condition - Patients undergoing non-cardiac surgery under general anesthesia Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

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 Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 01 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2027 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070667

Disclaimer: Curated by HT Syndication.