CClinicalTrials.gg
Status unknownNCT03745079TemperatureUpdated Mar 6, 2023

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

An observational study in Temperature and General Anesthesia, sponsored by Ajou University School of Medicine. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by Ajou University School of Medicine · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
80
Ages
19 Years to 60 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Temperature
  • General Anesthesia
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In context

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 171 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · Other: Spoton Temporal · Other: Spoton Carotid

Interventions

  • OtherEsophagus temperature monitoring

    Measuring core temperature by esophageal stethoscope

    Also known as: Core temperature

  • OtherSpoton Temporal

    Mesuring temperature on skin near to temporal artery using Spoton

    Also known as: Mesuring temperature on skin near to temporal artery

  • OtherSpoton Carotid

    Mesuring temperature on skin near to carotidl artery using Spoton

    Also known as: Mesuring temperature on skin near to carotid artery

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What researchers measure

Primary outcomes

  1. Esophageal core temperature measured by stethoscope ℃

    Temperature measured by esophageal stethoscope, ℃

    Time frame: 3 hours (during general anesthesia)

  2. Carotid skin temperature by SpotOn, ℃

    Temperature measured by SpotOn near to carotid artery, ℃

    Time frame: 3 hours (during general anesthesia)

  3. Temporal skin temperature by SpotOn, ℃

    Temperature measured by SpotOn near to temporal artery, ℃

    Time frame: 3 hours (during general anesthesia)

Secondary outcomes

  1. Room temperature, ℃

    Operating room temperature, ℃

    Time frame: 3 hours (during general anesthesia)

07

Study locations

1 of 1 sites recruiting
  • Ajou university school of medicine
    Suwon, Gyeonggi-do 16499, Korea, Republic of
    • In Kyong Yi, MD · Contact · lyrin01@hotmail.com · +82-10-3012-6972
    • Yoon Jung Chae, MD · Contact · +82-31-219-5689
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03745079
Lead sponsor
Ajou University School of Medicine
Responsible party
In-kyong Yi (Clinical assistant professor, Ajou University School of Medicine) — Principal investigator
First posted
Nov 19, 2018
Start date
Sep 20, 2019
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Mar 6, 2023

Study contacts

In Kyong Yi, MD
Contact
lyrin01@hotmail.com
+82312197522
In Kyong Yi, MD
principal investigator · Ajou University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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