- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05770830
Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients
Correlation Between Esophageal Temperature and Skin Temperature Measured by 3M™ Bair Hugger™ in Trauma Patients
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
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Suwon, Gyeonggi-do, Korea, Republic of, 16499
- Ajou University School of Medicine
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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™
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
accuracy
Time Frame: 3 hours
|
Mean difference between the two temperatures
|
3 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AJOUIRB-MDB-2021-557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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