TemperatureTemperatureNCT03745079
Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
An observational study of Temperature and General Anesthesia, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature 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 19 to 60 years
- Conditions the study is for
- Temperature, General Anesthesia
- What is being tested?
- Esophagus temperature monitoring, Spoton Temporal and Spoton Carotid
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2019to 31 Dec 2023
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who scheduled surgery more than 2 hours under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.
Who may be able to join
- Age 19~60 years old
- Who need surgery more than 2 hours under general anesthesia
- American Society of Anesthesiologists physical status 1 or 2
Who cannot join
- Body mass index < 35
- Head and neck surgery
- Patients with fever > 38'C
- History of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Ajou university school of medicine
Suwon, Gyeonggi-do, 16499
In Kyong Yi, MD, +82-10-3012-6972, lyrin01@hotmail.com
Yoon Jung Chae, MD, +82-31-219-5689
About this study
Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature 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 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery
Read the detailed description
Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M Spoton skin temeprature 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 Spoton on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery
- Conditions
- Temperature, General Anesthesia
- Being tested
- Esophagus temperature monitoring, Spoton Temporal, Spoton Carotid
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
Spoton TemporalOther
Also called Mesuring temperature on skin near to temporal artery
Mesuring temperature on skin near to temporal artery using Spoton
Spoton CarotidOther
Also called Mesuring temperature on skin near to carotid artery
Mesuring temperature on skin near to carotidl artery using Spoton
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Participants' temperature measured at 3 places at the same time
* Esophagus
* Skin near to temporal artery
* Skin near to carotid artery Receives: Other: Esophagus temperature monitoring; Other: Spoton Temporal; Other: Spoton Carotid |
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 SpotOn, ℃
Temperature measured by SpotOn near to carotid artery, ℃
Measured: 3 hours (during general anesthesia)
Temporal skin temperature by SpotOn, ℃
Temperature measured by SpotOn near to temporal 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 posted19 Nov 2018
- Study start20 Sep 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
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
- NCT03745079
- Sponsor's protocol ID
- MED-OBS-18-350
- Acronym
- Temperature
- Status last verified
- Mar 2023
- First submitted
- 12 Nov 2018
- Last updated
- 6 Mar 2023
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Core Temperature and Skin Temperature Measured by 3M SpotOn
- ClinicalTrials.gov ID
- NCT03745079
- Acronym / sponsor ID
- Temperature / MED-OBS-18-350
- Conditions
- Temperature, General Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Nov 2018 (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.
Core temperature should be monitored under general anesthesia. Recently developed 3M Spoton skin temeprature 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 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery
Detailed description
Core temperature should be monitored under general anesthesia. Because patients are prone to hypothermia during surgery. Conventional core temperature is monitored at esophagus, rectum, nasopharynx. But some of them are invasive and impossible in sometimes. Recently developed 3M Spoton skin temeprature 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 Spoton on carotid artery could be alternative method measuring core temperature. The purpose of this study is comparing 3 methods of temperature monitoring. First, conventional core temperature measure by esophageal stethoscope. Second, 3M Spoton applying on temporal artery. Third, 3M Spoton applying on carotid artery
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Esophagus temperature monitoring, Other: Spoton Temporal, Other: Spoton CarotidParticipants' temperature measured at 3 places at the same time * Esophagus * Skin near to temporal artery * Skin near to carotid artery |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who scheduled surgery more than 2 hours under general anesthesia. Who need esophageal temperature monitoring for routine monitoring.
Key inclusion criteria (3 listed)
- Age 19~60 years old
- Who need surgery more than 2 hours under general anesthesia
- American Society of Anesthesiologists physical status 1 or 2
Key exclusion criteria (4 listed)
- Body mass index < 35
- Head and neck surgery
- 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 | Group 1 |
| Spoton TemporalAlso: Mesuring temperature on skin near to temporal arteryMesuring temperature on skin near to temporal artery using Spoton | Other | Group 1 |
| Spoton CarotidAlso: Mesuring temperature on skin near to carotid arteryMesuring temperature on skin near to carotidl artery using Spoton | Other | Group 1 |
Primary outcome
Esophageal core temperature measured by stethoscope ℃
Time frame: 3 hours (during general anesthesia)
Temperature measured by esophageal stethoscope, ℃
Carotid skin temperature by SpotOn, ℃
Time frame: 3 hours (during general anesthesia)
Temperature measured by SpotOn near to carotid artery, ℃
Temporal skin temperature by SpotOn, ℃
Time frame: 3 hours (during general anesthesia)
Temperature measured by SpotOn near to temporal artery, ℃
1 secondary outcome
Room temperature, ℃
Time frame: 3 hours (during general anesthesia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- 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 and General 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: status not confirmed, as of the sponsor's last update on 6 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact In Kyong Yi, MD (+82312197522, lyrin01@hotmail.com), or a site near the patient. 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 3 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 6 Mar 2023.