Temperature Change, BodytemperatureNCT04057612
Correlation Between Core Temperature and Skin Temperature in Pediatrics
An observational study of Temperature Change, Body and Anesthesia, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Temperature Change, Body, Anesthesia, Children, Only
- What is being tested?
- Esophagus temperature monitoring and Carotid artery temperature monitoring
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 29 Sep 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 1 to 5 years old who scheduled surgery under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.
Who may be able to join
- scheduled operation under general anesthesia
- Who need esophageal temperature monitoring
- American society of anesthesiology physical status 1 or 2
Who cannot join
- Body mass index > 35 kg/m2
- Who cannot be inserted esophageal temperature prove
- Patients with fever > 38'C
- History of malignant hyperthermia
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 Core Temperature and Skin Temperature Near Carotid Artery Measured by 3M™ Bair Hugger™ in Pediatrics
During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.
Read the detailed description
Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using 3M™ Bair Hugger™ on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.
- Conditions
- Temperature Change, Body, Anesthesia, Children, Only
- Being tested
- Esophagus temperature monitoring, Carotid artery temperature monitoring
- Keywords
- pediatric, temperature, general anesthesia
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagus temperature monitoringOther
Also called core temperature
Measuring core temperature by esophageal stethoscope
Carotid artery temperature monitoringOther
Also called 3M™ Bair Hugger™ temperature monitoring
Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Pediatric participants | Participants' temperature measured at 2 places at the same time
* Esophagus
* Skin near to carotid artery Receives: Other: Esophagus temperature monitoring; Other: Carotid artery temperature monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal core temperature measured by stethoscope, ℃
Temperature measured by esophageal stethoscope, ℃
Measured: 3 hours (during general anesthesia)
Carotid skin temperature by 3M™ Bair Hugger™, ℃
Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ℃
Measured: 3 hours (during general anesthesia)
Secondary outcomes (1)
Room temperature, ℃
Operating room temperature, ℃
Measured: 3 hours (during general anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Aug 2022
- Study completion29 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies 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
- Prospective
- Enrolment
- 66 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
- Investigators
- In Kyong Yi, MD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057612
- Sponsor's protocol ID
- AJIRB-MED-OBS-19-277
- Acronym
- temperature
- Status last verified
- Sep 2022
- First submitted
- 13 Aug 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Core Temperature and Skin Temperature Near Carotid Artery Measured by 3M™ Bair Hugger™ in Pediatrics
- ClinicalTrials.gov ID
- NCT04057612
- Acronym / sponsor ID
- temperature / AJIRB-MED-OBS-19-277
- Conditions
- Temperature Change, Body, Anesthesia, Children, Only
- Keywords
- pediatric, temperature, general anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 15 Aug 2019 (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.
During general anesthesia, temperature monitoring is critical especially in pediatrics. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measure by esophageal prove in several studies. Conventional skin temperature over carotid artery is also correlated with core temperature in several studies. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.
Detailed description
Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery, besides, pediatric patients are more vulnerable in temperature control. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M™ Bair Hugger™ skin temperature which is applied on temporal artery is correlated with core temperature measured by esophageal prove in several studies. Its mechanism is making zero heat flux on skin applied. But it also cannot apply in head or facial surgery. Other studies showed conventional skin temperature over carotid artery is also correlated with core temperature. The investigators hypothesized using 3M™ Bair Hugger™ on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 2 methods of temperature monitoring in pediatrics. First, conventional core temperature measure by esophageal stethoscope. Second, 3M™ Bair Hugger™ applying on carotid artery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric participants | – | Other: Esophagus temperature monitoring, Other: Carotid artery temperature monitoringParticipants' temperature measured at 2 places at the same time * Esophagus * Skin near to carotid artery |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 1 to 5 years old who scheduled surgery under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.
Key inclusion criteria (3 listed)
- scheduled operation under general anesthesia
- Who need esophageal temperature monitoring
- American society of anesthesiology physical status 1 or 2
Key exclusion criteria (4 listed)
- Body mass index > 35 kg/m2
- Who cannot be inserted esophageal temperature prove
- Patients with fever > 38'C
- History of malignant hyperthermia
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 |
|---|---|---|
| Esophagus temperature monitoringAlso: core temperatureMeasuring core temperature by esophageal stethoscope | Other | Pediatric participants |
| Carotid artery temperature monitoringAlso: 3M™ Bair Hugger™ temperature monitoringMeasuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system | Other | Pediatric participants |
Primary outcome
Esophageal core temperature measured by stethoscope, ℃
Time frame: 3 hours (during general anesthesia)
Temperature measured by esophageal stethoscope, ℃
Carotid skin temperature by 3M™ Bair Hugger™, ℃
Time frame: 3 hours (during general anesthesia)
Temperature measured by 3M™ Bair Hugger™ near to carotid artery, ℃
1 secondary outcome
Room temperature, ℃
Time frame: 3 hours (during general anesthesia)
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 30 Sep 2022.
- Individual participant dataSharing planned: Undecided
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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.
In Kyong Yi, MD principal investigator
Ajou University School of Medicine
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 Temperature Change, Body and Anesthesia, 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 3 inclusion and 4 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 30 Sep 2022. 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?
Esophageal core temperature measured by stethoscope, ℃ (time frame: 3 hours (during general anesthesia)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2022.