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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)

2026年8月1日 更新者：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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

270

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 泰国
      • Khon Kaen、泰国、40002
        • Faculty of Medicine, Khon Kaen University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Khon Kaen University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月10日

初级完成 (估计的)

2027年2月28日

研究完成 (估计的)

2027年4月30日

研究注册日期

首次提交

2026年8月1日

首先提交符合 QC 标准的

2026年8月1日

首次发布 (实际的)

2026年8月6日

研究记录更新

最后更新发布 (实际的)

2026年8月6日

上次提交的符合 QC 标准的更新

2026年8月1日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • HE691250

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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