Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor

NCT07749209 | Not Yet Recruiting

• 1 other identifier: HE691250
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Intraoperative Temperature Monitoring; Body Temperature

Keywords

core temperature; temperature monitoring; nasopharyngeal probe; infrared tympanic thermometer; zero-heat-flux; SpotOn; TaiDoc TD-1261; Bland-Altman; agreement; method comparison; perioperative hypothermia

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From 15 minutes after anesthesia induction until surgery end (15-minute intervals)

• Proportional Bias Assessment

  From 15 minutes after anesthesia induction until surgery end

• Sensitivity and Specificity for Hypothermia Detection

  From 15 minutes after anesthesia induction until surgery end

• Intraclass Correlation Coefficient

  From 15 minutes after anesthesia induction until surgery end

• Percentage of Paired Measurements Within ±0.5°C

  From 15 minutes after anesthesia induction until surgery end

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (9)

• 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.

  PMID: 39885585 BACKGROUND

• Iden 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.

  PMID: 25693138 BACKGROUND

• Wan 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.

  PMID: 35797551 BACKGROUND

• Lu 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.

  PMID: 27838682 BACKGROUND

• Cork RC, Vaughan RW, Humphrey LS. Precision and accuracy of intraoperative temperature monitoring. Anesth Analg. 1983 Feb;62(2):211-4.

  PMID: 6829923 BACKGROUND

• Torossian 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.

  PMID: 19137809 BACKGROUND

• Matsukawa 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.

  PMID: 7879935 BACKGROUND

• Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.

  PMID: 18648241 BACKGROUND

• Sessler 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.

  PMID: 26775126 BACKGROUND

Central Study Contacts

Thepakorn Sathitkarnmanee, MD

CONTACT

66819547622; thepakorns@gmail.com

Sirirat Tribuddharat, MD, PhD

CONTACT

66816205920; sirirat.tribuddharat@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication of the primary manuscript; available for 5 years thereafter
• Access Criteria: Qualified researchers submitting a methodologically sound research proposal. Requests will be reviewed by the Principal Investigator. A signed data sharing agreement is required. Data will be provided in de-identified format via secure file transfer.

Locations

TH (1)