Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Temperature
1 other identifier
observational
80
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
September 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 6, 2023
March 1, 2023
4.3 years
November 12, 2018
March 3, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
Room temperature, ℃
3 hours (during general anesthesia)
Study Arms (1)
Group 1
Participants' temperature measured at 3 places at the same time * Esophagus * Skin near to temporal artery * Skin near to carotid artery
Interventions
Measuring core temperature by esophageal stethoscope
Mesuring temperature on skin near to temporal artery using Spoton
Mesuring temperature on skin near to carotidl artery using Spoton
Eligibility Criteria
Patients who scheduled surgery more than 2 hours under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.
You may qualify if:
- Age 19\~60 years old
- Who need surgery more than 2 hours under general anesthesia
- American Society of Anesthesiologists physical status 1 or 2
You may not qualify if:
- Body mass index \< 35
- Head and neck surgery
- Patients with fever \> 38'C
- History of malignant hyperthermia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
In Kyong Yi, MD
Ajou University School of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
November 12, 2018
First Posted
November 19, 2018
Study Start
September 20, 2019
Primary Completion
December 30, 2023
Study Completion
December 31, 2023
Last Updated
March 6, 2023
Record last verified: 2023-03