NCT04057612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2022

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

August 13, 2019

Last Update Submit

September 28, 2022

Conditions

Keywords

pediatrictemperaturegeneral anesthesia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Room temperature, ℃

    3 hours (during general anesthesia)

Study Arms (1)

Pediatric participants

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

Other: Esophagus temperature monitoringOther: Carotid artery temperature monitoring

Interventions

Measuring core temperature by esophageal stethoscope

Also known as: core temperature
Pediatric participants

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

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

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Body mass index \> 35 kg/m2
  • Who cannot be inserted esophageal temperature prove
  • Patients with fever \> 38'C
  • History of malignant hyperthermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou university school of medicine

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • In Kyong Yi, MD

    Ajou University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

September 1, 2019

Primary Completion

August 30, 2022

Study Completion

September 29, 2022

Last Updated

September 30, 2022

Record last verified: 2022-09

Locations