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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
时间窗: 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.
次要结局
- 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)
- Clinical Covariate Association With Method Difference(Baseline characteristics collected before surgery; temperature data from 15 minutes post-induction until surgery end)
- Incidence of Device-Related Adverse Events(From device placement until surgery end)
研究者
Thepakorn Sathitkarnmanee
Associate Professor
Khon Kaen University