Adult Optical NonInvasive Brain Oxygenation Monitor

成人光学无创脑氧合监测仪

基本信息

批准号：
7222990
负责人：
BO CHEN
金额：
$ 85.3万
依托单位：
CAS MEDICAL SYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2003
资助国家：
美国
起止时间：
2003-02-01 至 2010-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7222990
关键词：
Address Adult Algorithms Anesthesiology Basic Science Brain Caliber Cardiac Surgery procedures Cerebrum Childhood Clinical Clinical Data Condition Data Development Device Approval Devices Durable Medical Equipment Effectiveness Ensure Equilibrium Equipment Design Forehead Goals Head Hemoglobin Hypoxia Intensive Care Intervention Invasive Marketing Measurement Measures Medical Medical center Metabolism Modeling Modification Monitor Near-Infrared Spectroscopy Neurocognitive Neurologic Operative Surgical Procedures Optical Methods Optics Organ Outcome Outcome Measure Outcome Study Oxygen Oxygen saturation measurement Patients Phase Physicians Physiologic pulse Postoperative Period Protocols documentation Publishing Pulse Oximetry Pulse taking Range Recruitment Activity Reference Values Risk Safety Sampling Signal Transduction Standards of Weights and Measures System Testing Tissues United States Food and Drug Administration Validation Venous base biomaterial compatibility clinical application concept design improved in vivo natural hypothermia novel prototype radial artery sensor size tissue oxygenation trend validation studies volunteer

项目摘要

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.

描述（由申请人提供）：脑血氧计是一种光学方法，可在床边连续且非侵入性地测量脑组织氧饱和度（SCTO2）。脉搏血氧饱和度仅测量动脉氧饱和度（SAO2），脑血氧饱和度测量参数主要反映区域代谢和局部组织氧气供求的平衡。因此，在基础研究和临床环境中，准确的脑血氧仪将具有广泛的应用。然而，当前的脑血氧仪尚未达到其最初成为常规临床监测仪（如脉搏血氧仪法）的预期潜力。大脑血氧仪临床应用的主要挑战是证明此类监视器的有效性。需要解决的关键问题是能够量化光学信号并因此得出的算法的开发 SCTO2的绝对值。更重要的是，有必要建立阈值STO2值这与患者在各种临床情况下的临床结果相关。在对我们的概念验证原型脑血氧仪的II阶段验证研究中，我们证明了我们的经验得出的新型算法可以确定成人人中具有高度准确性的绝对脑SCTO2。我们假设我们的商业绝对脑血氧仪对成年人的性能类似。拟议的研究将着重于将现有的概念验证原型脑血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，以证明我们的商业脑血氧仪的有效性。如果成功，我们将由于商业大脑 FDA当前批准的血氧仪仅用于趋势监测。另外，我们预计拟议的临床结果研究的结果将为医生提供指导，以在各种临床情况下建立阈值SCTO2值。