Comparative Analysis of Core Body Temperature Measurement

Comparative Analysis of Core Body Temperature Measurement During Endoscopy: Esophageal Temperature Probe Versus Skin Temperature Sensors

Comparison and evaluation of the correlation, accuracy, and precision between a skin-attached temperature sensor and the standard method of deep body temperature measurement, the esophageal thermometer, by measuring and assessing both temperature measurement methods.

Study Overview

• Status: Recruiting
• Conditions: Temperature Change, Body
• Intervention / Treatment: Diagnostic test: Body temperature measurement

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: JEAYEON PARK, MD; Phone Number: 821036380746; Email: jyeonpark202@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy adults aged 19 years and above, but under 70 years

Exclusion Criteria:

• Cases where there were serious side effects during a previous examination performed under sedation or anesthesia
• Currently undergoing treatment for a diagnosed disease
• Diagnosed with esophageal varices or having a history of esophagitis
• Having undergone esophageal and gastric resection surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects	Diagnostic test: Body temperature measurement; Comparative analysis of temperature between esophageal temperature and skin temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body temperature	Esophageal Temperature Probe versus Skin Temperature Sensors	From enrollment to the end of the treatment at 1month

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Esophageal temperature; 3M Spot On; Zero heat flux temperature
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: 2311-164-1488

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes