Intraoperative Temperature MonitoringTEMP-AGREENCT07749209
Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor
An observational study of Intraoperative Temperature Monitoring and Body Temperature, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Keeping a patient's body temperature normal during surgery is an important part of safe anesthetic care. When the body temperature drops below 36°C (called inadvertent perioperative hypothermia), patients face higher risks of bleeding, wound infection, heart problems, and a slower recovery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intraoperative Temperature Monitoring, Body Temperature
- How many people
- 270 participants
- Where
- 1 siteThailand
- Study dates
- 10 Aug 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective surgery under general anesthesia with tracheal intubation at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand, with expected surgical duration ≥ 60 minutes and ASA Physical Status I-III.
Who may be able to join
- Age ≥ 18 years
- We will include 3 independent groups of patients receiving general anesthesia with tracheal intubation:
- Group 1: Cardiac surgery Group 2: Thoracic surgery Group 3: General surgery, including neurosurgery
- Expected surgical duration ≥ 60 minutes
- ASA Physical Status Classification I- III
- Able to provide written informed consent
Who cannot join
- Prior nasal surgery, nasal polyps, deviated nasal septum, or significant epistaxis history precluding safe nasopharyngeal probe insertion
- Otitis media, tympanic membrane perforation, significant cerumen impaction, or external auditory canal deformity that would prevent reliable infrared tympanic temperature measurement
- Facial or forehead skin lesions, burns, or known adhesive hypersensitivity at the planned 3M SpotOn™ application site, craniotomy, and head and neck surgery.
- Baseline core temperature < 35.0°C or > 38.5°C at preoperative assessment
- Planned use of neuraxial anesthesia as the primary or adjunct technique
- Emergency procedures, pregnancy, or procedures involving deliberate hypothermia or cardiopulmonary bypass.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Method-Comparison Study of the Agreement Among Nasopharyngeal Temperature Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Zero-Heat-Flux Skin Sensor for Intraoperative Core Temperature Monitoring in Adult Patients Undergoing Elective Surgery Under General Anesthesia
Keeping a patient's body temperature normal during surgery is an important part of safe anesthetic care. When the body temperature drops below 36°C (called inadvertent perioperative hypothermia), patients face higher risks of bleeding, wound infection, heart problems, and a slower recovery. To prevent these complications, anesthesiologists monitor core body temperature continuously during surgery.
Three monitoring methods are commonly used in clinical practice: (1) a nasopharyngeal probe - a small soft sensor inserted through the nose and placed at the back of the throat, which provides continuous readings and is considered the gold standard; (2) an infrared tympanic thermometer (TaiDoc TD-1261) - a handheld device that measures ear temperature in about one second; and (3) the 3M SpotOn™ sensor - a non-invasive adhesive patch placed on the forehead that continuously estimates core temperature without requiring insertion into any body cavity.
Read more
Although all three methods are used interchangeably at Srinagarind Hospital, no study has directly compared all three simultaneously in the same patient to determine how well they agree with each other. If significant differences exist between methods, a clinician who switches from one device to another may unknowingly under-detect or over-estimate hypothermia.
This study will enroll 92 adult patients scheduled for elective surgery under general anesthesia at Srinagarind Hospital, Khon Kaen University. All three temperature sensors will be applied at the same time, and readings will be recorded simultaneously every 15 minutes throughout the operation. The main goal is to determine whether each device gives results close enough to the nasopharyngeal probe to be safely used as an alternative. The study is observational - no medications or procedures will be added to routine care.
Read the detailed description
Background: Inadvertent perioperative hypothermia (IPH), defined as a core body temperature < 36.0°C, affects 20-90% of patients undergoing general anesthesia and is associated with coagulopathy, surgical site infection, morbid cardiac events, and prolonged drug metabolism. Accurate intraoperative temperature monitoring is mandated by professional society guidelines.
Study design: Prospective, single-center, triple-method observational agreement study at Srinagarind Hospital, Khon Kaen University, Thailand. All three thermometry modalities are applied simultaneously in each participant. No intervention is assigned; temperature monitoring is additional to standard perioperative care.
Methods: After induction of general anesthesia and tracheal intubation, the nasopharyngeal (NP) probe (reference standard), TaiDoc TD-1261 infrared tympanic thermometer (test method 1), and 3M SpotOn™ zero-heat-flux forehead sensor (test method 2) are placed. Simultaneous temperature readings are recorded at 15-minute intervals from 15 minutes after induction until surgery end. For the TD-1261, two consecutive readings are taken at each time point and averaged; pinna retraction and fresh disposable probe cover are used at every measurement. The SpotOn™ sensor requires a 10-minute equilibration period before the first recorded value.
Statistical analysis: Primary analysis uses repeated-measures Bland-Altman analysis (Myles \& Cui, 2007 framework) to estimate bias and limits of agreement (LoA) for each method pair against the NP probe. Pre-specified clinical acceptability criterion: LoA within ±0.5°C (Sessler, 2008). Variance of differences is decomposed into between-subject (σ²_B) and within-subject (σ²_W) components. Secondary analyses: proportional bias assessment, sensitivity/specificity for hypothermia detection (NP < 36.0°C), intraclass correlation coefficient (ICC, two-way mixed-effects model), and multivariable linear mixed-effects regression for clinical covariates. Sample size: 92 patients (Lu et al., 2016 method; 80% power; α = 0.05; SD of differences = 0.30°C for NP vs. TM; LoA acceptability threshold ±0.50°C; 15% dropout allowance).
This study provides the first institution-specific, population-specific evidence on temperature monitoring agreement in Thai surgical patients and constitutes the first published intraoperative validation of the TaiDoc TD-1261 infrared tympanic thermometer.
- Keywords
- core temperature, temperature monitoring, nasopharyngeal probe, infrared tympanic thermometer, zero-heat-flux, SpotOn, TaiDoc TD-1261, Bland-Altman; agreement, method comparison, perioperative hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Patients - All Three Monitoring Methods | Adult patients (age ≥ 18 years) undergoing elective surgery under general anesthesia with tracheal intubation at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University, with an expected surgical duration ≥ 60 minutes and ASA Physical Status I-III. All participants have all three temperature monitoring devices (NP probe, TaiDoc TD-1261 IR tympanic thermometer, and 3M SpotOn™ ZHF sensor) applied simultaneously following induction of anesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
The 95% limits of agreement (LoA = Bias ± 1.96 × SD_total) between (i) the TaiDoc TD-1261 infrared tympanic thermometer and the nasopharyngeal probe, and (ii) the 3M SpotOn™ sensor and the nasopharyngeal probe, estimated by repeated-measures Bland-Altman analysis. Pre-specified clinical acceptability criterion: LoA must be contained within ±0.5°C with both 95% CI limits of the upper and lower LoA falling within this range.
Measured: From 15 minutes after anesthesia induction until end of surgery; measurements recorded at 15-minute intervals (estimated total observation window: 60-195 minutes per participant)
Secondary outcomes (7)
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
Mean difference (°C) with 95% CI between each test method and the NP probe across all paired observations, estimated from the repeated-measures Bland-Altman model
Measured: From 15 minutes after anesthesia induction until surgery end (15-minute intervals)
Proportional Bias Assessment
Linear regression of the difference (test - reference) on the mean of both methods, with cluster-robust standard errors; Pitman's test for correlation between sum and difference
Measured: From 15 minutes after anesthesia induction until surgery end
Sensitivity and Specificity for Hypothermia Detection
Sensitivity, specificity, PPV, and NPV of each test method for detecting intraoperative hypothermia defined as NP temperature < 36.0°C, with AUROC estimated by DeLong's method
Measured: From 15 minutes after anesthesia induction until surgery end
Intraclass Correlation Coefficient
ICC (two-way mixed-effects model, absolute agreement) with 95% CI for each method pair
Measured: From 15 minutes after anesthesia induction until surgery end
Percentage of Paired Measurements Within ±0.5°C
Percentage of all paired simultaneous readings in which the test method falls within ±0.5°C of the simultaneous NP reference reading
Measured: From 15 minutes after anesthesia induction until surgery end
Clinical Covariate Association With Method Difference
Association between clinical covariates (age, sex, BMI, ASA status, surgical duration, anesthetic technique, active warming use, ambient OR temperature, baseline core temperature) and the absolute method difference, estimated by multivariable linear mixed-effects regression
Measured: Baseline characteristics collected before surgery; temperature data from 15 minutes post-induction until surgery end
Incidence of Device-Related Adverse Events
Rate of epistaxis (NP probe), aural discomfort or canal injury (TD-1261), and adhesive skin reaction (SpotOn™) during the monitoring period
Measured: From device placement until surgery end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Intraoperative Temperature MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749209
- Sponsor's protocol ID
- HE691250
- Acronym
- TEMP-AGREE
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant temperature measurement data, baseline characteristics, and covariate data will be made available to qualified researchers following publication of the primary results in a peer-reviewed journal, subject to a data sharing agreement. Requests should be directed to the principal investigator.
Publications
Wang J, Liang H, Tian C, Rong G, Shao X, Ran C. Agreement of zero-heat-flux thermometry compared with infrared tympanic temperature monitoring in adults undergoing major surgery. Eur J Med Res. 2025 Jan 30;30(1):60. doi: 10.1186/s40001-025-02317-9.
PubMed 39885585Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232.
PubMed 25693138Wan L, Shen PY, Zhang SX, Wang LZ. Agreement of infrared ear temperature with nasopharyngeal temperature and diagnostic performance on hypothermia in general anesthetized patients. J Chin Med Assoc. 2022 Nov 1;85(11):1093-1097. doi: 10.1097/JCMA.0000000000000770. Epub 2022 Jul 6.
PubMed 35797551Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.
PubMed 27838682Cork RC, Vaughan RW, Humphrey LS. Precision and accuracy of intraoperative temperature monitoring. Anesth Analg. 1983 Feb;62(2):211-4.
PubMed 6829923Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
PubMed 19137809Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
PubMed 7879935Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
PubMed 26775126
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Method-Comparison Study of the Agreement Among Nasopharyngeal Temperature Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Zero-Heat-Flux Skin Sensor for Intraoperative Core Temperature Monitoring in Adult Patients Undergoing Elective Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07749209
- Acronym / sponsor ID
- TEMP-AGREE / HE691250
- Keywords
- core temperature, temperature monitoring, nasopharyngeal probe, infrared tympanic thermometer, zero-heat-flux, SpotOn, TaiDoc TD-1261, Bland-Altman; agreement
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 6 Aug 2026 (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.
Keeping a patient's body temperature normal during surgery is an important part of safe anesthetic care. When the body temperature drops below 36°C (called inadvertent perioperative hypothermia), patients face higher risks of bleeding, wound infection, heart problems, and a slower recovery. To prevent these complications, anesthesiologists monitor core body temperature continuously during surgery.
Three monitoring methods are commonly used in clinical practice: (1) a nasopharyngeal probe - a small soft sensor inserted through the nose and placed at the back of the throat, which provides continuous readings and is considered the gold standard; (2) an infrared tympanic thermometer (TaiDoc TD-1261) - a handheld device that measures ear temperature in about one second; and (3) the 3M SpotOn™ sensor - a non-invasive adhesive patch placed on the forehead that continuously estimates core temperature without requiring insertion into any body cavity.
Although all three methods are used interchangeably at Srinagarind Hospital, no study has directly compared all three simultaneously in the same patient to determine how well they agree with each other. If significant differences exist between methods, a clinician who switches from one device to another may unknowingly under-detect or over-estimate hypothermia.
This study will enroll 92 adult patients scheduled for elective surgery under general anesthesia at Srinagarind Hospital, Khon Kaen University. All three temperature sensors will be applied at the same time, and readings will be recorded simultaneously every 15 minutes throughout the operation. The main goal is to determine whether each device gives results close enough to the nasopharyngeal probe to be safely used as an alternative. The study is observational - no medications or procedures will be added to routine care.
Detailed description
Background: Inadvertent perioperative hypothermia (IPH), defined as a core body temperature < 36.0°C, affects 20-90% of patients undergoing general anesthesia and is associated with coagulopathy, surgical site infection, morbid cardiac events, and prolonged drug metabolism. Accurate intraoperative temperature monitoring is mandated by professional society guidelines.
Study design: Prospective, single-center, triple-method observational agreement study at Srinagarind Hospital, Khon Kaen University, Thailand. All three thermometry modalities are applied simultaneously in each participant. No intervention is assigned; temperature monitoring is additional to standard perioperative care.
Methods: After induction of general anesthesia and tracheal intubation, the nasopharyngeal (NP) probe (reference standard), TaiDoc TD-1261 infrared tympanic thermometer (test method 1), and 3M SpotOn™ zero-heat-flux forehead sensor (test method 2) are placed. Simultaneous temperature readings are recorded at 15-minute intervals from 15 minutes after induction until surgery end. For the TD-1261, two consecutive readings are taken at each time point and averaged; pinna retraction and fresh disposable probe cover are used at every measurement. The SpotOn™ sensor requires a 10-minute equilibration period before the first recorded value.
Statistical analysis: Primary analysis uses repeated-measures Bland-Altman analysis (Myles \& Cui, 2007 framework) to estimate bias and limits of agreement (LoA) for each method pair against the NP probe. Pre-specified clinical acceptability criterion: LoA within ±0.5°C (Sessler, 2008). Variance of differences is decomposed into between-subject (σ²_B) and within-subject (σ²_W) components. Secondary analyses: proportional bias assessment, sensitivity/specificity for hypothermia detection (NP < 36.0°C), intraclass correlation coefficient (ICC, two-way mixed-effects model), and multivariable linear mixed-effects regression for clinical covariates. Sample size: 92 patients (Lu et al., 2016 method; 80% power; α = 0.05; SD of differences = 0.30°C for NP vs. TM; LoA acceptability threshold ±0.50°C; 15% dropout allowance).
This study provides the first institution-specific, population-specific evidence on temperature monitoring agreement in Thai surgical patients and constitutes the first published intraoperative validation of the TaiDoc TD-1261 infrared tympanic thermometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Patients - All Three Monitoring Methods | – | –Adult patients (age ≥ 18 years) undergoing elective surgery under general anesthesia with tracheal intubation at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Khon Kaen University, with an expected surgical duration ≥ 60 minutes and ASA Physical Status I-III. All participants have all three temperature monitoring devices (NP probe, TaiDoc TD-1261 IR tympanic thermometer, and 3M SpotOn™ ZHF sensor) applied simultaneously following induction of anesthesia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective surgery under general anesthesia with tracheal intubation at Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand, with expected surgical duration ≥ 60 minutes and ASA Physical Status I-III.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- We will include 3 independent groups of patients receiving general anesthesia with tracheal intubation:
- Group 1: Cardiac surgery Group 2: Thoracic surgery Group 3: General surgery, including neurosurgery
- Expected surgical duration ≥ 60 minutes
- ASA Physical Status Classification I- III
Key exclusion criteria (6 listed)
- Prior nasal surgery, nasal polyps, deviated nasal septum, or significant epistaxis history precluding safe nasopharyngeal probe insertion
- Otitis media, tympanic membrane perforation, significant cerumen impaction, or external auditory canal deformity that would prevent reliable infrared tympanic temperature measurement
- Facial or forehead skin lesions, burns, or known adhesive hypersensitivity at the planned 3M SpotOn™ application site, craniotomy, and head and neck surgery.
- Baseline core temperature < 35.0°C or > 38.5°C at preoperative assessment
- Planned use of neuraxial anesthesia as the primary or adjunct technique
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
Time frame: From 15 minutes after anesthesia induction until end of surgery; measurements recorded at 15-minute intervals (estimated total observation window: 60-195 minutes per participant)
The 95% limits of agreement (LoA = Bias ± 1.96 × SD_total) between (i) the TaiDoc TD-1261 infrared tympanic thermometer and the nasopharyngeal probe, and (ii) the 3M SpotOn™ sensor and the nasopharyngeal probe, estimated by repeated-measures Bland-Altman analysis. Pre-specified clinical acceptability criterion: LoA must be contained within ±0.5°C with both 95% CI limits of the upper and lower LoA falling within this range.
7 secondary outcomes
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
Time frame: From 15 minutes after anesthesia induction until surgery end (15-minute intervals)
Proportional Bias Assessment
Time frame: From 15 minutes after anesthesia induction until surgery end
Sensitivity and Specificity for Hypothermia Detection
Time frame: From 15 minutes after anesthesia induction until surgery end
Intraclass Correlation Coefficient
Time frame: From 15 minutes after anesthesia induction until surgery end
Percentage of Paired Measurements Within ±0.5°C
Time frame: From 15 minutes after anesthesia induction until surgery end
Clinical Covariate Association With Method Difference
Time frame: Baseline characteristics collected before surgery; temperature data from 15 minutes post-induction until surgery end
Incidence of Device-Related Adverse Events
Time frame: From device placement until surgery end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Background: PubMed 39885585Wang J, Liang H, Tian C, Rong G, Shao X, Ran C. Agreement of zero-heat-flux thermometry compared with infrared tympanic temperature monitoring in adults undergoing major surgery. Eur J Med Res. 2025 Jan 30;30(1):60. doi: 10.1186/s40001-025-02317-9.
- Background: PubMed 25693138Iden T, Horn EP, Bein B, Bohm R, Beese J, Hocker J. Intraoperative temperature monitoring with zero heat flux technology (3M SpotOn sensor) in comparison with sublingual and nasopharyngeal temperature: An observational study. Eur J Anaesthesiol. 2015 Jun;32(6):387-91. doi: 10.1097/EJA.0000000000000232.
- Background: PubMed 35797551Wan L, Shen PY, Zhang SX, Wang LZ. Agreement of infrared ear temperature with nasopharyngeal temperature and diagnostic performance on hypothermia in general anesthetized patients. J Chin Med Assoc. 2022 Nov 1;85(11):1093-1097. doi: 10.1097/JCMA.0000000000000770. Epub 2022 Jul 6.
- Background: PubMed 27838682Lu MJ, Zhong WH, Liu YX, Miao HZ, Li YC, Ji MH. Sample Size for Assessing Agreement between Two Methods of Measurement by Bland-Altman Method. Int J Biostat. 2016 Nov 1;12(2):/j/ijb.2016.12.issue-2/ijb-2015-0039/ijb-2015-0039.xml. doi: 10.1515/ijb-2015-0039.
- Background: PubMed 6829923Cork RC, Vaughan RW, Humphrey LS. Precision and accuracy of intraoperative temperature monitoring. Anesth Analg. 1983 Feb;62(2):211-4.
- Background: PubMed 19137809Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
- Background: PubMed 7879935Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
- Background: PubMed 18648241Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Background: PubMed 26775126Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8.
- Individual participant dataSharing planned: Yes. Deidentified individual participant temperature measurement data, baseline characteristics, and covariate data will be made available to qualified researchers following publication of the primary results in a peer-reviewed journal, subject to a data sharing agreement. Requests should be directed to the principal investigator.
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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.
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 Intraoperative Temperature Monitoring and Body Temperature, run by Khon Kaen University at 1 site in Thailand.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 6 Aug 2026. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thepakorn Sathitkarnmanee, MD (66819547622, thepakorns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe (time frame: From 15 minutes after anesthesia induction until end of surgery; measurements recorded at 15-minute intervals (estimated total observation window: 60-195 minutes per participant)). 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 NCT07749209, which also lists 9 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 6 Aug 2026.