Correlation Between Esophageal Temperature and Skin Tempe... | NCT05770830

Studies
Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients

NCT05770830

Sponsor

Ajou University School of Medicine

Status

Completed

Last Update Posted

Apr 10, 2023Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Core Temperature
Trauma

Interventions

Esophageal temperature
Skin core temperature

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Mar 4, 2023

First Submission Date that Met QC Criteria

Mar 4, 2023

First Posted Date

Mar 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2023

Last Update Posted Date

Apr 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

In-kyong Yi, Assistana professor, Ajou University School of MedicinePrincipal Investigator

Lead Sponsor

Ajou University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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, the correlation between the skin core temperature and the esophageal temperature was investigated

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Esophageal temperature		Esophageal temperature	Device: Esophageal temperature
Skin core temperature		Skin core temperature	Device: Skin core temperature

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esophageal temperature	Device	Temperature data measured by esophageal temperature probe (disposable probe, Ace-medical, Seoul, Korea)	Esophageal temperature

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
accuracy	Mean difference between the two temperatures	3 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajou university school of medicine		Suwon	Gyeonggi-do	16499	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42101749	Derived	Lee J, Ahn H, Sohn HM, Song SH, Yi IK. Clinical agreement and physiological relevance of the zero-heat-flux temperature measurement in trauma patients during operating room resuscitation. J Clin Monit Comput. 2026 May 8. doi: 10.1007/s10877-026-01441-z. Online ahead of print.