Brain Trauma Assessment System

描述（由申请人提供）：在美国，每年有超过150万人遭受头部损伤，大约5万人死于这些损伤，因此需要对脑损伤进行早期直接评估。目前，损伤必须从格拉斯哥昏迷评分（GCS）、低血压和/或低脉搏血氧测定来推断，但没有直接的方法来测量现场的大脑状况。Active Signal公司提议测试一种小型、便携、手持设备，对脑损伤进行非侵入性测量，即使在缺乏患者反应的情况下也能直接评估损伤。因此，将脑损伤与药物、酒精和低血糖引起的低CGS区分开来，并将信息用于分诊甚至早期干预。脑外伤评估系统（BTAS）以马里兰大学休克创伤中心（STC）成功识别150名创伤患者神经系统状态的系统为模型。在这里，急救人员将在受伤现场和运输过程中对患者使用BTAS。测量结果将与STC入院时的诊断结果进行比较，以评估该装置的敏感性和特异性。主动信号会作出调整，以配合环境管理系统的需要，为第二期的广泛研究作准备。

DESCRIPTION (provided by applicant): With over 1.5 million persons suffering head injury annually in the U.S., and approximately 50,000 dying from these injuries, a need exists for early direct assessment of brain injury. Currently, injuries must be inferred from Glascow Coma Scores (GCS), low blood pressure, and/or low pulse oximetry, but there is no direct method of measuring brain condition at the scene. Active Signal proposes to test a small, portable, hand-held device to perform non-invasive measurements of brain injury, allowing direct assessment of injury even with lack of patient responsiveness. Thus, brain injury will be distinguished from low CGS caused by drugs, alcohol and hypoglycemia, and the information used for triaging and even early intervention. The brain trauma assessment system (BTAS) is modeled on one that has successfully identified neurological status on >150 trauma patients at the University of Maryland Shock Trauma Center (STC). Here, EMTs will use the BTAS on patients at the scene of injury and during transport. The measurements will be compared to the diagnosis upon admission to the STC to evaluate the device's sensitivity and specificity. Active Signal will make adjustments to accommodate demands of the EMS environment in preparation for a broad study in Phase II.