Correlation Between Core Temperature and Skin Temperature in Pediatrics (temperature)

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Children, Only; Temperature Change, Body
• Intervention / Treatment: Other: Esophagus temperature monitoring; Other: Carotid artery temperature monitoring

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 1 to 5 years old who scheduled surgery under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric participants; Participants' temperature measured at 2 places at the same time; Esophagus; Skin near to carotid artery	Other: Esophagus temperature monitoring; Measuring core temperature by esophageal stethoscope; Other Names: core temperature; Other: Carotid artery temperature monitoring; Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system; Other Names: 3M™ Bair Hugger™ temperature monitoring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Room temperature, ℃	Operating room temperature, ℃	3 hours (during general anesthesia)

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): August 30, 2022
• Study Completion (ACTUAL): September 29, 2022

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 13, 2019
• First Posted (ACTUAL): August 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pediatric; general anesthesia; temperature
• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: AJIRB-MED-OBS-19-277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No