Correlation Between Core Temperature and Skin Temperature in Pediatrics

Completed

• Conditions: Temperature Change, Body; Anesthesia; Children, Only
• Interventions: Other: Esophagus temperature monitoring; Other: Carotid artery temperature monitoring

• Registration Number: NCT04057612
• Lead Sponsor: Ajou University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Study Start: 2019-09-01
• Primary Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Study Completion: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric participants	Carotid artery temperature monitoring	Participants' temperature measured at 2 places at the same time * Esophagus * Skin near to carotid artery
Pediatric participants	Esophagus temperature monitoring	Participants' temperature measured at 2 places at the same time * Esophagus * Skin near to carotid artery

Primary Outcome Measures

Name	Time	Method
Esophageal core temperature measured by stethoscope, ℃	3 hours (during general anesthesia)	Temperature measured by esophageal stethoscope, ℃
Carotid skin temperature by 3M™ Bair Hugger™, ℃	3 hours (during general anesthesia)	Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ℃

Secondary Outcome Measures

Name	Time	Method
Room temperature, ℃	3 hours (during general anesthesia)	Operating room temperature, ℃

Trial Locations

Locations (1)

Ajou university school of medicine; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of