Correlation Between Core Temperature and Skin Temperature in Pediatrics

Anesthesia Clinical Trial

— temperature  

Official title:

Correlation Between Core Temperature and Skin Temperature Near Carotid Artery Measured by 3M™ Bair Hugger™ in Pediatrics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057612
• Other study ID #: AJIRB-MED-OBS-19-277
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 29, 2022

Study information

• Verified date: September 2022
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature 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 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.

Description:

Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™ skin temperature 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 3M™ Bair Hugger™ on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 29, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

• scheduled operation under general anesthesia

• Who need esophageal temperature monitoring

• American society of anesthesiology physical status 1 or 2

Exclusion Criteria:

• Body mass index > 35 kg/m2

• Who cannot be inserted esophageal temperature prove

• Patients with fever > 38'C

• History of malignant hyperthermia

Related Conditions & MeSH terms

• Anesthesia
• Body Temperature Changes
• Children, Only
• Temperature Change, Body

Intervention

Other:
• Esophagus temperature monitoring
Measuring core temperature by esophageal stethoscope
• Carotid artery temperature monitoring
Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system

Locations

Country	Name	City	State
Korea, Republic of	Ajou university school of medicine	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Esophageal core temperature measured by stethoscope, ?	Temperature measured by esophageal stethoscope, ?	3 hours (during general anesthesia)
Primary	Carotid skin temperature by 3M™ Bair Hugger™, ?	Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ?	3 hours (during general anesthesia)
Secondary	Room temperature, ?	Operating room temperature, ?	3 hours (during general anesthesia)