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OpenTrials
Completed

NCT Number: NCT04057612

Correlation Between Core Temperature and Skin Temperature 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.

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esophagus temperature monitoring

Other

Measuring core temperature by esophageal stethoscope

Other names: core temperature

Carotid artery temperature monitoring

Other

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

Other names: 3M™ Bair Hugger™ temperature monitoring

Primary outcomes

  1. Esophageal core temperature measured by stethoscope, ℃

    Time frame: 3 hours (during general anesthesia)

    Temperature measured by esophageal stethoscope, ℃

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

    Time frame: 3 hours (during general anesthesia)

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

Secondary outcomes

  1. Room temperature, ℃

    Time frame: 3 hours (during general anesthesia)

    Operating room temperature, ℃

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Acronym: temperature

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 15, 2019
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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