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临床试验/NCT04571554
NCT04571554已完成不适用

Accuracy of Infrared Thermography for Detecting Febrile Critically Ill Patients: a Prospective Cohort Study

Kasr El Aini Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
1
主要终点
Accuracy of IRT to detect fever (≥38.3⁰C).

研究概览

简要总结

Accurate determination of critically ill patient of being febrile or not is an essential part of management critically ill patients as it prompt investigating the underlying cause and initiating therapeutic action.

Pulmonary artery catheter thermistor is considered the gold standard for temperature measurement . Central non-vascular thermometer such as esophageal, bladder and rectal thermometer showed excellent correlation and agreement with pulmonary artery catheter thermistor and has been accepted as alternative methods for core body temperature assessment. However, those methods are invasive and cannot be tolerated in conscious patients. Peripheral thermometer such as oral, axillary and tympanic membrane thermometer are either impractical in unconscious patient and/or carry the risk of trauma and infection.

Infrared thermography (IRT) is a non-contact and non-invasive imaging approach that enable real-time estimation of body temperature by detecting infrared emission. IRT had been used for screening for mass detection of febrile patients at airport at times of infectious disease outbreak. In adult population, IRT showed good accuracy in detecting febrile patients in emergency department; however, those studies used 37.7⁰ C as the fever threshold and the reference standard was either oral 6 or tympanic membrane thermometer. No studies to the best of our knowledge had evaluated the IRT accuracy in detecting fever in critically ill patients using esophageal thermometer as a reference method.

详细描述

The enrolled patient will be sedated according to the ICU protocol. A calibrated esophageal thermometer will be inserted by the attending intensivist through the nostril or oral cavity into the lower third of the esophagus to approximately 10-20 cm.

IRT will be performed using FLIR C2 compact thermal camera. The focal length of the thermal camera will be adjusted at 0.5 meter from the patient head. scanning will conducted over a period of 10-seconds. The researcher will record the highest reading obtained from medial canthus. No cold fomentations will be applied to the head nor the axilla of the patient for 30 minutes at least before measuring IRT.

FLIR C2 thermal camera will be calibrated before use to eliminate the effect of the ambient room temperature.

The researcher of will obtain the IRT temperature will be blinded to the esophageal probe reading.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Critically ill intubated adult patients (>18 years)

排除标准

  • Patients with condition that preclude the application of esophageal thermometer such as esophageal varices, diverticulum, stenosis and malignancy
  • patients with eye pathology as inflammation or malignancy which would interfere with the interpretation of the IRT reading,
  • Pregnant women.

结局指标

主要结局

Accuracy of IRT to detect fever (≥38.3⁰C).

时间窗: from focusing the camera on the patients face for 10 seconds

Accuracy of IRT to detect fever (≥38.3⁰C) measured by esophageal thermometer

次要结局

  • Correlation between IRT temperature readings and the simultaneous esophageal thermometer reading(from focusing the camera on the patients face for 10 seconds)
  • Bias and agreement in IRT temperature readings and the simultaneous esophageal thermometer reading(from focusing the camera on the patients face for 10 seconds)
  • Comparison the accuracy of IRT and tympanic membrane temperature in detecting fever(from focusing the camera on the patients face for 10 seconds)
  • Comparison the accuracy of IRT and axillary temperature in detecting fever(from focusing the camera on the patients face for 10 seconds)

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Mostafa Ahmad, MD

Principal Investigator

Kasr El Aini Hospital

研究点 (1)

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