AccuTemp Sensor: Radiometry based non-invasive continuous core body temperature monitoring for patients undergoing prolonged anesthesia and critically ill patients.

AccuTemp 传感器：基于辐射测量的无创连续核心体温监测，适用于长时间麻醉的患者和危重患者。

• 批准号: 8834124
• 负责人: Douglas O Reudink
• 金额: $ 74.18万
• 依托单位: THERMIMAGE, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-01 至 2017-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8834124
• 关键词: Address; Amplifiers; Anesthesia procedures; Bladder; Body Temperature; Brain; Bypass; Caliber; Calibration; Cardiac Surgery procedures; Cardiopulmonary Bypass; Caring; Cerebrum; Cessation of life; Clinical; Clinical Research; Clinics and Hospitals; Computer software; Critical Illness; Data; Detection; Development; Development Plans; Device Approval; Devices; Diagnostic; Electromagnetics; Electronics; Emergency Department Physician; Environment; Esophageal; Esophagus; Feedback; Forehead; Frequencies; Goals; Head; Health Personnel; Healthcare; Hemorrhage; Hospitalization; Hour; Human; Immune; Institutional Review Boards; Intensive Care; Intensive Care Units; Ischemic Neuronal Injury; Kidney; Length; Letters; Lung; Marketing; Measurement; Measures; Medical; Medical Device; Medical Research; Mission; Modeling; Monitor; Myocardial; Nasopharynx; Operative Surgical Procedures; Organ; Outcome; Patient Monitoring; Patients; Phase; Physicians; Pilot Projects; Population Study; Practice Guidelines; Preparation; Printing; Procedures; Process; Protocols documentation; Public Health; Pulmonary artery structure; Quality of Care; Radiometry; Reader; Reading; Recovery; Rectum; Regulation; Research; Signal Transduction; Site; Small Business Innovation Research Grant; Staging; Structure of jugular vein; System; Technology; Temperature; Testing; Tissues; Translating; Traumatic Brain Injury; Universities; Utah; Validation; Work; base; brain tissue; clinical application; clinical investigation; clinical practice; commercialization; cost; design; detector; improved; innovation; instrument; instrumentation; interest; microwave electromagnetic radiation; natural hypothermia; new technology; non-invasive monitor; novel; operation; prevent; prototype; public health relevance; rectal; research and development; research clinical testing; sensor; success; technological innovation; tool

DESCRIPTION (provided by applicant): There is a growing need for accurate and continuous non-invasive monitoring of brain temperature in hospitals and clinics throughout the world. The need for physicians and anesthesiologists to know the brain as well as the core body temperature of a patient is well established. Temperature management of patients under anesthesia during cardio-pulmonary bypass surgery is imperative to a positive outcome and ongoing patient quality of care, yet there is no non-invasive, accurate measurement device available to physicians. Current practice guidelines for anesthesiologists, intensive care physicians, neonatologists, and emergency physicians require the monitoring of the core brain temperature. However, there are no devices that provide immediate, accurate data. Devices that are non-invasive only measure superficial temperatures, insufficient for critical situations. Invasive monitors are placed into the bladder, rectum, esophagus or the nasopharynx to measure core temperature more accurately, but the medical professional must then infer the most important temperature, brain temperature, with the hope that this is "accurate enough" for critical medical decisions during surgical operations and difficult intensive care unit stays. Thee are several devices that attempt to measure brain temperature. The most accurate prediction of brain temperature today uses intravascular sensors in the pulmonary artery or jugular vein, but these are invasive, inconvenient and potentially harmful. Even sensors directly in the brain have shown that when hypothermia is induced and reversed rapidly, standard monitoring sites fail to reflect cerebral temperature. With success in kidney and bladder temperature detection and monitoring, Thermimage is now developing the AccuTemp" Sensor, a non-invasive radiometric based system to accurately and rapidly measure the core brain temperature 5 cm deep. This system consists of a >2.5 cm diameter receiving microwave antenna placed on the patient's forehead, and a specialized radiometer to amplify and process the antenna signal to determine the actual brain temperature. The device detects the energy emitted from the brain at low frequencies with a sensitive receiver that detects signal strength of only a billionth of a watt. There is a clear need for a new, non-invasive temperature measurement device that provides fast and accurate readings of the body's most sensitive tissue, the brain. This Phase II SBIR research and development will demonstrate: 1) the noninvasive sensing technology successfully prepared in Phase I provides reliable monitoring of deep core brain temperature during hypothermic surgery; and 2) the cutting-edge radiometer prototype built in Phase I can be translated into a low-cost system that combines technological innovation with universal commercial appeal and clinical validation.

描述（由申请人提供）：在世界各地的医院和诊所中，对脑温度的准确和连续的非侵入性监测的需求日益增长。医生和麻醉师需要了解患者的大脑以及核心体温。心肺转流手术期间麻醉下患者的温度管理对于积极的结果和持续的患者护理质量至关重要，但没有无创的精确测量设备可供医生使用。 目前麻醉医师、重症监护医师、麻醉医师和急诊医师的实践指南要求监测核心脑温度。然而，没有设备可以提供即时、准确的数据。非侵入性设备仅测量表面温度，不足以用于关键情况。侵入式监测器被放置到膀胱、直肠、食道或鼻咽中以更准确地测量核心温度，但是医疗专业人员必须随后推断最重要的温度，即大脑温度，希望这对于外科手术和困难的重症监护病房期间的关键医疗决策是“足够准确的”。 有几种装置试图测量大脑温度。目前，对大脑温度最准确的预测是使用肺动脉或颈静脉中的血管内传感器，但这些传感器具有侵入性，不方便且可能有害。即使是直接在大脑中的传感器也表明，当低温被诱导并迅速逆转时，标准监测部位无法反映大脑温度。 随着肾脏和膀胱温度检测和监测的成功，Thermimage现在正在开发AccuTemp”传感器，这是一种基于辐射测量的非侵入性系统，可以准确快速地测量5 cm深的核心大脑温度。该系统由放置在患者前额上的直径>2.5 cm的接收微波天线和用于放大和处理天线信号以确定实际大脑温度的专用辐射计组成。该设备通过一个灵敏的接收器检测大脑发出的低频能量，该接收器检测到的信号强度仅为十亿分之一瓦。 显然需要一种新的非侵入式温度测量设备，可以快速准确地读取人体最敏感的组织-大脑。第二阶段SBIR研究和开发将证明：1）在第一阶段成功准备的非侵入性传感技术在低温手术期间提供了对深部核心脑温度的可靠监测; 2）第一阶段构建的尖端辐射计原型可以转化为一个低成本系统，将技术创新与普遍的商业吸引力和临床验证相结合。