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

1 augustus 2026 bijgewerkt door: Thepakorn Sathitkarnmanee, Khon Kaen University

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.

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

270

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Faculty of Medicine, Khon Kaen University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
Tijdsspanne: 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.
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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
Tijdsspanne: From 15 minutes after anesthesia induction until surgery end (15-minute intervals)
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
From 15 minutes after anesthesia induction until surgery end (15-minute intervals)
Proportional Bias Assessment
Tijdsspanne: From 15 minutes after anesthesia induction until surgery end
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
From 15 minutes after anesthesia induction until surgery end
Sensitivity and Specificity for Hypothermia Detection
Tijdsspanne: From 15 minutes after anesthesia induction until surgery end
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
From 15 minutes after anesthesia induction until surgery end
Intraclass Correlation Coefficient
Tijdsspanne: From 15 minutes after anesthesia induction until surgery end
ICC (two-way mixed-effects model, absolute agreement) with 95% CI for each method pair
From 15 minutes after anesthesia induction until surgery end
Percentage of Paired Measurements Within ±0.5°C
Tijdsspanne: From 15 minutes after anesthesia induction until surgery end
Percentage of all paired simultaneous readings in which the test method falls within ±0.5°C of the simultaneous NP reference reading
From 15 minutes after anesthesia induction until surgery end
Clinical Covariate Association With Method Difference
Tijdsspanne: Baseline characteristics collected before surgery; temperature data from 15 minutes post-induction until surgery end
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
Baseline characteristics collected before surgery; temperature data from 15 minutes post-induction until surgery end
Incidence of Device-Related Adverse Events
Tijdsspanne: From device placement until surgery end
Rate of epistaxis (NP probe), aural discomfort or canal injury (TD-1261), and adhesive skin reaction (SpotOn™) during the monitoring period
From device placement until surgery end

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Khon Kaen University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

10 augustus 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

30 april 2027

Studieregistratiedata

Eerst ingediend

1 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 augustus 2026

Eerst geplaatst (Werkelijk)

6 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

1 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • HE691250

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Starting 6 months after publication of the primary manuscript; available for 5 years thereafter

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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