Patients Undergoing General AnesthesiaNCT04964232
Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures
A study testing Infrared Camera, Esophageal Temperature Probe and Skin temperature probe in people with Patients Undergoing General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial summary
"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body… Read more about this study
- Who is it for?
- Ages 19 to 78 years
- Conditions the study is for
- Patients Undergoing General Anesthesia
- What is being tested?
- Infrared Camera, Esophageal Temperature Probe and Skin temperature probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2021to Sep 2021
- Phase
- Interventional
- 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. An adult who underwent endoscopic/laparotomy Hepatectomy of living donor, Pylorus preserving pancreaticoduodenectomy, Renal allograft, Flexible ureterorenoscopic removal of calculus of upper ureter with regular surgery
Who cannot join
- 1. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Jeongmin Kim, +82 10-8926-2684, ANESJEONGMIN@yuhs.ac
About this study
"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body temperature non-invasive as it may feel uncomfortable during placement and maintenance management. Various methods have been developed to measure body temperature noninvasive, such as in the mouth, armpits, skin surfaces, and aural canals. However, developed methods can also cause discomfort to patients in that they attach sensors to their skin.
In this study, we use the esophageal temperature measurement method, the skin contact temperature measurement method, and the IR contactless temperature measurement method to simultaneously measure body temperature and to compare the accuracy of body temperature measurement according to each method."
- Conditions
- Patients Undergoing General Anesthesia
- Being tested
- Infrared Camera, Esophageal Temperature Probe, Skin temperature probe
- Keywords
- core-temperature, non-contact temperature measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared CameraDevice
The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.
Esophageal Temperature ProbeDevice
In patients undergoing general anesthesia, the Esophageal temeperature parameters are measured using an Esophageal probe.
Skin temperature probeDevice
In patients undergoing general anesthesia, the skin spot temeperature parameters are measured using an skin adhesive probe.
| Study group | Role | What they receive |
|---|---|---|
| Temperature monitoring group | Experimental | The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera. Receives: Device: Infrared Camera; Device: Esophageal Temperature Probe; Device: Skin temperature probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of core-temperature measurements
The accuracy of core-temperature measurements between infrared camera,esophageal probe and skin probe in patients with general anesthesia
Measured: Intraoperative period about 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Feb 2021
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeongmin Kim, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964232
- Sponsor's protocol ID
- 1-2020-0083
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
PubMed 7879936Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.
PubMed 18931198Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.
PubMed 15211129Boggan WO, Meyer JS. Effects of serotonergic drugs on methaqualone-induced hypothermia. Res Commun Chem Pathol Pharmacol. 1977 Apr;16(4):629-36.
PubMed 140451Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.
PubMed 18431110Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.
PubMed 18156884Poveda VB, Nascimento AS. Intraoperative body temperature control: esophageal thermometer versus infrared tympanic thermometer. Rev Esc Enferm USP. 2016 Nov-Dec;50(6):946-952. doi: 10.1590/S0080-623420160000700010. English, Portuguese.
PubMed 28198959Callanan D. Detecting fever in young infants: reliability of perceived, pacifier, and temporal artery temperatures in infants younger than 3 months of age. Pediatr Emerg Care. 2003 Aug;19(4):240-3. doi: 10.1097/01.pec.0000086231.54586.15.
PubMed 12972820Morley CJ, Hewson PH, Thornton AJ, Cole TJ. Axillary and rectal temperature measurements in infants. Arch Dis Child. 1992 Jan;67(1):122-5. doi: 10.1136/adc.67.1.122.
PubMed 1739325Muma BK, Treloar DJ, Wurmlinger K, Peterson E, Vitae A. Comparison of rectal, axillary, and tympanic membrane temperatures in infants and young children. Ann Emerg Med. 1991 Jan;20(1):41-4. doi: 10.1016/s0196-0644(05)81116-3.
PubMed 1984726Cattaneo CG, Frank SM, Hesel TW, El-Rahmany HK, Kim LJ, Tran KM. The accuracy and precision of body temperature monitoring methods during regional and general anesthesia. Anesth Analg. 2000 Apr;90(4):938-45. doi: 10.1097/00000539-200004000-00030.
PubMed 10735803Jean-Mary MB, Dicanzio J, Shaw J, Bernstein HH. Limited accuracy and reliability of infrared axillary and aural thermometers in a pediatric outpatient population. J Pediatr. 2002 Nov;141(5):671-6. doi: 10.1067/mpd.2002.127664.
PubMed 12410196Negishi T, Abe S, Matsui T, Liu H, Kurosawa M, Kirimoto T, Sun G. Contactless Vital Signs Measurement System Using RGB-Thermal Image Sensors and Its Clinical Screening Test on Patients with Seasonal Influenza. Sensors (Basel). 2020 Apr 13;20(8):2171. doi: 10.3390/s20082171.
PubMed 32294973
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Body Temperature Measurement Using Infrared Camera: Comparison With Esophageal, and Skin Temperatures
- ClinicalTrials.gov ID
- NCT04964232
- Acronym / sponsor ID
- 1-2020-0083
- Conditions
- Patients Undergoing General Anesthesia
- Keywords
- core-temperature, non-contact temperature measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 16 Jul 2021 (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.
"A method of monitoring body temperature during surgery is to measure esophageal temperature using a catheter. Although this method is known as a method to accurately measure core temperature, it is not recommended for local anesthesia patients and requires an invasive procedure that can be used to monitor body temperature non-invasive as it may feel uncomfortable during placement and maintenance management. Various methods have been developed to measure body temperature noninvasive, such as in the mouth, armpits, skin surfaces, and aural canals. However, developed methods can also cause discomfort to patients in that they attach sensors to their skin.
In this study, we use the esophageal temperature measurement method, the skin contact temperature measurement method, and the IR contactless temperature measurement method to simultaneously measure body temperature and to compare the accuracy of body temperature measurement according to each method."
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temperature monitoring group | Experimental | Device: Infrared Camera, Device: Esophageal Temperature Probe, Device: Skin temperature probeThe core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera. |
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. An adult who underwent endoscopic/laparotomy Hepatectomy of living donor, Pylorus preserving pancreaticoduodenectomy, Renal allograft, Flexible ureterorenoscopic removal of calculus of upper ureter with regular surgery
Key exclusion criteria (1 listed)
- 1. Subjects at risk of bleeding due to esophageal probe, and past cranial, esophageal varicose veins surgery.
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 |
|---|---|---|
| Infrared CameraThe core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera. | Device | Temperature monitoring group |
| Esophageal Temperature ProbeIn patients undergoing general anesthesia, the Esophageal temeperature parameters are measured using an Esophageal probe. | Device | Temperature monitoring group |
| Skin temperature probeIn patients undergoing general anesthesia, the skin spot temeperature parameters are measured using an skin adhesive probe. | Device | Temperature monitoring group |
Primary outcome
The accuracy of core-temperature measurements
Time frame: Intraoperative period about 1 hour
The accuracy of core-temperature measurements between infrared camera,esophageal probe and skin probe in patients with general anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Background: PubMed 7879936Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009.
- Background: PubMed 18931198Hannenberg AA, Sessler DI. Improving perioperative temperature management. Anesth Analg. 2008 Nov;107(5):1454-7. doi: 10.1213/ane.0b013e318181f6f2. No abstract available.
- Background: PubMed 15211129Wolberg AS, Meng ZH, Monroe DM 3rd, Hoffman M. A systematic evaluation of the effect of temperature on coagulation enzyme activity and platelet function. J Trauma. 2004 Jun;56(6):1221-8. doi: 10.1097/01.ta.0000064328.97941.fc.
- Background: PubMed 140451Boggan WO, Meyer JS. Effects of serotonergic drugs on methaqualone-induced hypothermia. Res Commun Chem Pathol Pharmacol. 1977 Apr;16(4):629-36.
- Background: PubMed 18431110Langesaeter E. Is it more informative to focus on cardiac output than blood pressure during spinal anesthesia for cesarean delivery in women with severe preeclampsia? Anesthesiology. 2008 May;108(5):771-2. doi: 10.1097/ALN.0b013e31816bbe04. No abstract available.
- Background: PubMed 18156884Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.
- Background: PubMed 28198959Poveda VB, Nascimento AS. Intraoperative body temperature control: esophageal thermometer versus infrared tympanic thermometer. Rev Esc Enferm USP. 2016 Nov-Dec;50(6):946-952. doi: 10.1590/S0080-623420160000700010. English, Portuguese.
- Background: PubMed 12972820Callanan D. Detecting fever in young infants: reliability of perceived, pacifier, and temporal artery temperatures in infants younger than 3 months of age. Pediatr Emerg Care. 2003 Aug;19(4):240-3. doi: 10.1097/01.pec.0000086231.54586.15.
- Background: PubMed 1739325Morley CJ, Hewson PH, Thornton AJ, Cole TJ. Axillary and rectal temperature measurements in infants. Arch Dis Child. 1992 Jan;67(1):122-5. doi: 10.1136/adc.67.1.122.
- Background: PubMed 1984726Muma BK, Treloar DJ, Wurmlinger K, Peterson E, Vitae A. Comparison of rectal, axillary, and tympanic membrane temperatures in infants and young children. Ann Emerg Med. 1991 Jan;20(1):41-4. doi: 10.1016/s0196-0644(05)81116-3.
- Background: PubMed 10735803Cattaneo CG, Frank SM, Hesel TW, El-Rahmany HK, Kim LJ, Tran KM. The accuracy and precision of body temperature monitoring methods during regional and general anesthesia. Anesth Analg. 2000 Apr;90(4):938-45. doi: 10.1097/00000539-200004000-00030.
- Background: PubMed 12410196Jean-Mary MB, Dicanzio J, Shaw J, Bernstein HH. Limited accuracy and reliability of infrared axillary and aural thermometers in a pediatric outpatient population. J Pediatr. 2002 Nov;141(5):671-6. doi: 10.1067/mpd.2002.127664.
- 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.
Jeongmin Kim principal investigator
Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infrared Camera, Esophageal Temperature Probe and Skin temperature probe in people with Patients Undergoing General Anesthesia, run by Yonsei University 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 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 2021. 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 Jeongmin Kim (+82 10-8926-2684, ANESJEONGMIN@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of core-temperature measurements (time frame: Intraoperative period about 1 hour). 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 NCT04964232, which also lists 13 linked publications.
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 16 Jul 2021.