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Trial record 11 of 80602 for:    measured

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

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ClinicalTrials.gov Identifier: NCT03745079
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
In-kyong Yi, Ajou University School of Medicine

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

Condition or disease Intervention/treatment
Temperature General Anesthesia 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

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
Actual Study Start Date : September 20, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019

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 Name: Core temperature

Other: Spoton Temporal
Mesuring temperature on skin near to temporal artery using Spoton
Other Name: Mesuring temperature on skin near to temporal artery

Other: Spoton Carotid
Mesuring temperature on skin near to carotidl artery using Spoton
Other Name: Mesuring temperature on skin near to carotid artery




Primary Outcome Measures :
  1. Esophageal core temperature measured by stethoscope ℃ [ Time Frame: 3 hours (during general anesthesia) ]
    Temperature measured by esophageal stethoscope, ℃

  2. Carotid skin temperature by SpotOn, ℃ [ Time Frame: 3 hours (during general anesthesia) ]
    Temperature measured by SpotOn near to carotid artery, ℃

  3. Temporal skin temperature by SpotOn, ℃ [ Time Frame: 3 hours (during general anesthesia) ]
    Temperature measured by SpotOn near to temporal artery, ℃


Secondary Outcome Measures :
  1. Room temperature, ℃ [ Time Frame: 3 hours (during general anesthesia) ]
    Operating room temperature, ℃



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03745079


Contacts
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Contact: In Kyong Yi, MD +82312197522 lyrin01@hotmail.com

Locations
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Korea, Republic of
Ajou university school of medicine Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16499
Contact: In Kyong Yi, MD    +82-10-3012-6972    lyrin01@hotmail.com   
Contact: Yoon Jung Chae, MD    +82-31-219-5689      
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: In Kyong Yi, MD Ajou University School of Medicine

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Responsible Party: In-kyong Yi, Clinical assistant professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT03745079     History of Changes
Other Study ID Numbers: MED-OBS-18-350
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No