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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)

2026년 8월 1일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

270

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Limits of Agreement Between Each Test Method and the Nasopharyngeal Probe
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Systematic Bias (Mean Difference) of Each Test Method vs. NP Probe
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Khon Kaen University

간행물 및 유용한 링크

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일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 10일

기본 완료 (추정된)

2027년 2월 28일

연구 완료 (추정된)

2027년 4월 30일

연구 등록 날짜

최초 제출

2026년 8월 1일

QC 기준을 충족하는 최초 제출

2026년 8월 1일

처음 게시됨 (실제)

2026년 8월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 1일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • HE691250

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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