Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients

Sponsor

Ajou University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT05770830

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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, we investigate whether the skin core temperature matches the esophageal temperature.

Condition or Disease	Intervention/Treatment	Phase
Core Temperature Trauma	Device: Esophageal temperature Device: Skin core temperature

Detailed 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 temeprature 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 temperatue properly.

3M™ Bair Hugger™ temperature monitoring system was develped 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 studis have reported that skin core temperature reflects core temperatue 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, we use the anesthesia records.

Study Design

Study Type:

Observational

Actual Enrollment :

54 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Esophageal temperature Esophageal temperature	Device: Esophageal temperature Temperature data measured by esophageal temperature probe
Skin core temperature Skin core temperature	Device: Skin core temperature Temperature data measured by skin core temperature device

Arm

Intervention/Treatment

Esophageal temperature

Device: Esophageal temperature

Temperature data measured by esophageal temperature probe

Skin core temperature

Device: Skin core temperature

Temperature data measured by skin core temperature device

Outcome Measures

Primary Outcome Measures

accuracy [3 hours]
Mean difference between the two temperatures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou university school of medicine	Suwon	Gyeonggi-do	Korea, Republic of	16499

Sponsors and Collaborators

Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-kyong Yi, Assistana professor, Ajou University School of Medicine

ClinicalTrials.gov Identifier:

NCT05770830

Other Study ID Numbers:

AJOUIRB-MDB-2021-557

First Posted:

Mar 16, 2023

Last Update Posted:

Mar 16, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Mar 16, 2023