Brain Trauma Assessment System

描述(申请人提供)：在美国，每年有超过150万人遭受头部损伤，约有50,000人死于这些损伤，因此有必要对脑损伤进行早期直接评估。目前，损伤必须通过格拉斯哥昏迷评分(GCS)、低血压和/或低脉搏血氧饱和度来推断，但没有直接测量现场大脑状况的方法。Active Signal建议测试一种小型、便携式、手持设备，以执行脑损伤的非侵入性测量，即使在缺乏患者反应性的情况下也可以直接评估损伤。因此，脑损伤将与药物、酒精和低血糖引起的低CGS以及用于分诊甚至早期干预的信息区分开来。脑创伤评估系统(BTAS)是以成功识别马里兰大学休克创伤中心(STC)150名创伤患者的神经状态的系统为原型的。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。这些测量结果将与STC入院时的诊断结果进行比较，以评估该设备的敏感性和特异性。Active Signal将进行调整，以适应EMS环境的需求，为第二阶段的广泛研究做准备。

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.