臨床研究等提出・公開システム

Date of registration	June. 23, 2025
Last modified on	June. 23, 2025
Trial ID	jRCT1012250016

Scientific Title	Evaluation of the Accuracy of the Moni-PatchTM Noninvasive Core Temperature Monitoring System in Obese Patients Under General Anesthesia: A Prospective Observational Comparison with Tympanic Temperature
Public Title	Evaluating the Accuracy of Moni-PatchTM for Measuring Body Temperature During Surgery in Obese Patients

Contact for Scientific Queries	Name	Tachibana Shunsuke
	Affiliation	Sapporo Medical University School of Medicine
	Address	Department of Anesthesiology, Sapporo Medical University, School of Medicine, Sapporo, Japan South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
	Telephone	+81-116112111
	E-mail	shunsuke.tachibana@gmail.com
Contact for Public Queries	Name	Tanaka Soichi
	Affiliation	Sapporo Medical University School of Medicine
	Address	Department of Anesthesiology, Sapporo Medical University, School of Medicine, Sapporo, Japan South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
	Telephone	+81-11-611-2111
	E-mail	soichi.t321@gmail.com

Recruitment status	Pending

Anticipated date of first enrollment		June. 23, 2025
Target sample size		47
Study Type		Observational
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	crossover assignment
	purpose	diagnostic purpose
Key inclusion & exclusion criteria	Inclusion Criteria	obese patients with a BMI thirty or more undergoing general anesthesia
	Exclusion Criteria	Patients were excluded if they had otolaryngological diseases that contraindicated the placement of a tympanic membrane probe, were scheduled to undergo right-sided head and neck surgery, were to undergo surgery in which the temperature probe would interfere with the surgical field, if informed consent could not be obtained from the patient, or if the attending anesthesiologist, principal investigator, or co-investigators judged the patient to be otherwise unsuitable for participation in this study.
	Age Minimum	18age 0month 0week old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Intraoperative core body temperature monitoring in patients with obesity.
Health Condition(s) Keyword		Obese, Perioperative hypothermia
Health Condition(s) Code		D009765
Primary Outcome(s)		Mean difference between neck temperature and tympanic temperature
Secondary Outcome(s)		Correlation coefficients of the measurements and the proportion within the clinically acceptable range

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	The Institutional Review Board of the Sapporo Medical University School of Medicine Hospital
Address	Sapporo Medical University, School of Medicine, Sapporo, Japan South 1, West 16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan, Hokkaido
Telephone	+81-11-611-2111
E-Mail	soichi.t321@gmail.com
Approval Status	Approval
Date of approval	June. 12, 2025

Plan to share IPD	Yes
Plan description	The individual participant data collected in this study will be thoroughly anonymized to prevent the identification of any individuals, and are planned to be shared with collaborating institutions or academic organizations, through appropriate procedures, for use in future related research and academic purposes.

Countries of Recruitment（Except Japan）	none