Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn (Temperature)

Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery

Study Overview

• Status: Recruiting
• Conditions: General Anesthesia; Temperature
• Intervention / Treatment: Other: Esophagus temperature monitoring; Other: Spoton Temporal; Other: Spoton Carotid

Detailed Description

Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M Spoton skin temeprature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using Spoton on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: In Kyong Yi, MD; Phone Number: +82312197522; Email: lyrin01@hotmail.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Recruiting
      • Ajou University School of Medicine
      • Contact: In Kyong Yi, MD; Phone Number: +82-10-3012-6972; Email: lyrin01@hotmail.com
      • Contact: Yoon Jung Chae, MD; Phone Number: +82-31-219-5689

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who scheduled surgery more than 2 hours under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.

Description

Inclusion Criteria:

• Age 19~60 years old
• Who need surgery more than 2 hours under general anesthesia
• American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

• Body mass index < 35
• Head and neck surgery
• Patients with fever > 38'C
• History of malignant hyperthermia

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Group 1; Participants' temperature measured at 3 places at the same time; Esophagus; Skin near to temporal artery; Skin near to carotid artery

Other: Esophagus temperature monitoring; Measuring core temperature by esophageal stethoscope; Other Names: Core temperature; Other: Spoton Temporal; Mesuring temperature on skin near to temporal artery using Spoton; Other Names: Mesuring temperature on skin near to temporal artery; Other: Spoton Carotid; Mesuring temperature on skin near to carotidl artery using Spoton; Other Names: Mesuring temperature on skin near to carotid artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal core temperature measured by stethoscope ℃	Temperature measured by esophageal stethoscope, ℃	3 hours (during general anesthesia)
Carotid skin temperature by SpotOn, ℃	Temperature measured by SpotOn near to carotid artery, ℃	3 hours (during general anesthesia)
Temporal skin temperature by SpotOn, ℃	Temperature measured by SpotOn near to temporal artery, ℃	3 hours (during general anesthesia)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Room temperature, ℃	Operating room temperature, ℃	3 hours (during general anesthesia)

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 12, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MED-OBS-18-350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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