Core TemperatureNCT05770830
Correlation Between Esophageal Temperature and Skin Temperature in Trauma Patients
An observational study of Core Temperature and Trauma, run by Ajou University School of Medicine at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Core Temperature, Trauma
- What is being tested?
- Esophageal temperature and Skin core temperature
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021
Who may be able to join
- 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
Who cannot join
- When more than half of the data is missing
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
About this study
Official title: 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
Read the 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.
- Conditions
- Core Temperature, Trauma
- Being tested
- Esophageal temperature, Skin core temperature
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal temperatureDevice
Temperature data measured by esophageal temperature probe (disposable probe, Ace-medical, Seoul, Korea)
Skin core temperatureDevice
Temperature data measured by skin core temperature device measured by 3M™ Bair Hugger™
| Study group | Role | What they receive |
|---|---|---|
| Esophageal temperature | Esophageal temperature Receives: Device: Esophageal temperature | |
| Skin core temperature | Skin core temperature Receives: Device: Skin core temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
Mean difference between the two temperatures
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Core TemperatureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-kyong Yi, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770830
- Sponsor's protocol ID
- AJOUIRB-MDB-2021-557
- Status last verified
- Apr 2023
- First submitted
- 4 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We can shre the data when there is a reasonable request to the corresponding author.
Publications
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 Aug;40(4):867-873. doi: 10.1007/s10877-026-01441-z. Epub 2026 May 8.
PubMed 42101749
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Esophageal Temperature and Skin Temperature Measured by 3M™ Bair Hugger™ in Trauma Patients
- ClinicalTrials.gov ID
- NCT05770830
- Acronym / sponsor ID
- AJOUIRB-MDB-2021-557
- Conditions
- Core Temperature, Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Esophageal temperature | – | Device: Esophageal temperatureEsophageal temperature |
| Skin core temperature | – | Device: Skin core temperatureSkin core temperature |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Trauma patients who underwent emergency surgery from January 1, 2021 to October 31, 2021
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- When more than half of the data is missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophageal temperatureTemperature data measured by esophageal temperature probe (disposable probe, Ace-medical, Seoul, Korea) | Device | Esophageal temperature |
| Skin core temperatureTemperature data measured by skin core temperature device measured by 3M™ Bair Hugger™ | Device | Skin core temperature |
Primary outcome
accuracy
Time frame: 3 hours
Mean difference between the two temperatures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Derived from this study: PubMed 42101749Lee 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 Aug;40(4):867-873. doi: 10.1007/s10877-026-01441-z. Epub 2026 May 8.
- Individual participant dataSharing planned: Undecided. We can shre the data when there is a reasonable request to the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Core Temperature and Trauma, run by Ajou University School of Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.