NCT03745079

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

November 12, 2018

Last Update Submit

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

Other: Esophagus temperature monitoringOther: Spoton TemporalOther: Spoton Carotid

Interventions

Measuring core temperature by esophageal stethoscope

Also known as: Core temperature
Group 1

Mesuring temperature on skin near to temporal artery using Spoton

Also known as: Mesuring temperature on skin near to temporal artery
Group 1

Mesuring temperature on skin near to carotidl artery using Spoton

Also known as: Mesuring temperature on skin near to carotid artery
Group 1

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

In Kyong Yi, MD

CONTACT

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

Locations