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NCT05770830 Clinical Trial

Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients

Trauma Clinical Trial

Official title:
Correlation Between Esophageal Temperature and Skin Temperature Measured by 3M™ Bair Hugger™ in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05770830
Other study ID # AJOUIRB-MDB-2021-557
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2022

Study information
Verified date April 2023
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this retrospective data-based study is to investigate the correlation between esophageal temperature and skin core temperature in trauma patients who underwent emergency surgery. Based on the medical records of patients who applied both temperature measurements simultaneously, the correlation between the skin core temperature and the esophageal temperature was investigated

Description:

Hypothermia is known to be one of the factors that increase mortality rate in trauma patients. Therefore it is important to measure and manage the core temperature in trauma patients. Esophageal temperature is common method to measure core temperature in patients undergoing surgery under general anesthesia. However, it is not applicable in patients who have not been intubated or in patients with suspected esophageal damage. In addition, esophageal temperature probe is twisted in the mouth and does not reflect core temperature properly. 3M™ Bair Hugger™ temperature monitoring system was developed to measure the core temperature by attaching to the skin using zero heat flow mechanism. It is simple to apply, and available at the trauma scene. Previous studies have reported that skin core temperature reflects core temperature well, but no studies have been conducted on trauma patients with rapid changes in the core temperature and poor perfusion state. This retrospective data-based study investigate the medical records of trauma patients who underwent emergency surgery. Patients who applied two temperature measurements at the same time were targeted. Since this center has the system that automatically transfer the hemodynamic data of the monitor to the anesthesia record, the investigators use the anesthesia records.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years to 90 Years
Eligibility Inclusion Criteria: - Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021 - Who applied both a esophageal thermometer and a 3M™ Bair Hugger™ temperature monitoring system at the same time Exclusion Criteria: - When more than half of the data is missing

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Esophageal temperature
Temperature data measured by esophageal temperature probe (disposable probe, Ace-medical, Seoul, Korea)
• Skin core temperature
Temperature data measured by skin core temperature device measured by 3M™ Bair Hugger™

Locations
Country Name City State
Korea, Republic of Ajou university school of medicine Suwon Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary accuracy Mean difference between the two temperatures 3 hours
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