Agreement Among Three Methods of Intraoperative Core Temperature Monitoring: Nasopharyngeal Probe, TaiDoc TD-1261 Infrared Tympanic Thermometer, and 3M SpotOn™ Skin Sensor (TEMP-AGREE)
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.
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Thepakorn Sathitkarnmanee, MD
- Número de telefone: 66819547622
- E-mail: thepakorns@gmail.com
Estude backup de contato
- Nome: Sirirat Tribuddharat, MD, PhD
- Número de telefone: 66816205920
- E-mail: sirirat.tribuddharat@gmail.com
Locais de estudo
-
-
-
Khon Kaen, Tailândia, 40002
- Faculty of Medicine, Khon Kaen University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- 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.
- 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.
- Cork RC, Vaughan RW, Humphrey LS. Precision and accuracy of intraoperative temperature monitoring. Anesth Analg. 1983 Feb;62(2):211-4.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- HE691250
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .