ClinicalTrials.gg
CompletedNCT04057612temperatureUpdated Sep 30, 2022

Correlation Between Core Temperature and Skin Temperature in Pediatrics

An observational study in Temperature Change, Body, Anesthesia and Children, Only, sponsored by Ajou University School of Medicine. Completed at 1 site in Korea, Republic of. Open to participants aged 1 Year to 5 Years. Per ClinicalTrials.gov, last updated 2022-09-30.

Sponsored by Ajou University School of Medicine · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
66
Ages
1 Year to 5 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temperature Change, Body
  • Anesthesia
  • Children, Only

Keywords

  • pediatric
  • temperature
  • general anesthesia
03

In context

Body Temperature Changes

97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.

This study's enrollment of 66 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.

Browse Body Temperature Changes studies →

Lead sponsor

Ajou University School of Medicine is the lead sponsor of 173 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 5 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • scheduled operation under general anesthesia
  • Who need esophageal temperature monitoring
  • American society of anesthesiology physical status 1 or 2

Exclusion criteria

Exclusion Criteria:

  • > 35 kg/m2
  • Who cannot be inserted esophageal temperature prove
  • Patients with fever > 38'C
  • History of malignant hyperthermia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • Pediatric participants

    Participants' temperature measured at 2 places at the same time * Esophagus * Skin near to carotid artery

    Other: Esophagus temperature monitoring · Other: Carotid artery temperature monitoring

Interventions

  • OtherEsophagus temperature monitoring

    Measuring core temperature by esophageal stethoscope

    Also known as: core temperature

  • OtherCarotid artery temperature monitoring

    Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system

    Also known as: 3M™ Bair Hugger™ temperature monitoring

06

What researchers measure

Primary outcomes

  1. Esophageal core temperature measured by stethoscope, ℃

    Temperature measured by esophageal stethoscope, ℃

    Time frame: 3 hours (during general anesthesia)

  2. Carotid skin temperature by 3M™ Bair Hugger™, ℃

    Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ℃

    Time frame: 3 hours (during general anesthesia)

Secondary outcomes

  1. Room temperature, ℃

    Operating room temperature, ℃

    Time frame: 3 hours (during general anesthesia)

07

Study locations

1 site
  • Ajou university school of medicine
    Suwon, Gyeonggi-do 16499, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04057612
Responsible party
In-kyong Yi (Clinical Assistant Professor, Ajou University School of Medicine) — Principal investigator
First posted
Aug 15, 2019
Start date
Sep 1, 2019
Primary completion
Aug 30, 2022
Completion
Sep 29, 2022
Last update
Sep 30, 2022

Study contacts

In Kyong Yi, MD
principal investigator · Ajou University School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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