Adult Optical NonInvasive Brain Oxygenation Monitor

描述(申请人提供)：脑氧仪是一种在床边连续、无创地测量脑组织氧饱和度(SctO2)的光学方法。与仅测量动脉血氧饱和度(SaO2)的脉搏血氧仪相比，脑血氧仪测量的参数主要反映局部新陈代谢和局部组织氧供应/需求的平衡。因此，精确的脑血氧仪在基础研究和临床环境中都将有广泛的应用。然而，目前的脑血氧仪还没有实现其最初预期的潜力，成为像脉搏血氧仪一样的常规临床监测仪。脑血氧仪临床应用的主要挑战是证明 这类监测员的有效性。需要解决的关键问题是 开发能够量化光学信号的算法，从而推导出 SctO2的绝对值。更重要的是，有必要建立阈值StO2 这与患者在不同临床情况下的临床结果相关。在我们的概念验证原型脑氧仪的第二阶段验证研究中，我们证明了我们的经验性派生的新算法可以在成年人中以高精度确定绝对的大脑SctO2。我们假设，我们的商用绝对式脑氧仪在成年人身上也有类似的表现。拟议的研究将侧重于将现有的概念验证原型脑氧仪转化为商业产品。此外，我们将进行验证和临床结果研究，以证明我们的商用脑氧仪的有效性。如果成功，我们将 FDA批准的第一台绝对式脑氧仪商业化，自商业化以来 目前FDA批准的血氧计仅用于趋势监测。此外，我们 预期拟议的临床结果研究的结果将为医生提供指导，以建立适用于各种临床情况的SctO2阈值。

DESCRIPTION (provided by applicant): Cerebral oximetry is an optical method that measures cerebral tissue oxygen saturation (SctO2) continuously and non-invasively at the bedside. Complimentary to pulse oximetry, which only measures arterial oxygen saturation (SaO2), cerebral oximetry measures parameters that mostly reflect regional metabolism and the balance of local tissue oxygen supply/demand. Therefore, an accurate cerebral oximeter would have a wide range of applications, both in basic research and clinical settings. However, current cerebral oximeters have yet to achieve their initially expected potential of becoming a routine clinical monitor like pulse oximeters. The main challenge for clinical application of cerebral oximeters has been to demonstrate the effectiveness of such monitors. The critical issue that needs to be addressed is the development of algorithms that are able to quantify the optical signals and therefore derive absolute values of SctO2. More importantly, it is necessary to establish threshold StO2 values that correlate with patients' clinical outcomes for various clinical situations. In Phase II validation study of our proof-of-concept prototype cerebral oximeter, we demonstrated that our empirically derived novel algorithm could determine absolute cerebral SctO2 with a high degree of accuracy in the adult human. We hypothesize that our commercial absolute cerebral oximeter will perform similarly for adult humans. The proposed studies will focus on transforming the existing proof-of-concept prototype cerebral oximeter into a commercial product. Furthermore, we will conduct validation and clinical outcome studies to demonstrate the effectiveness of our commercial cerebral oximeter. If successful, we will commercialize the first FDA approved absolute cerebral oximeter, since commercial cerebral oximeters currently approved by the FDA are for trending only monitoring. In addition, we anticipate that result from the proposed clinical outcome studies will provide physicians guidance to establish threshold SctO2 values for various clinical situations.