Adult Optical Non-Invasive Brain Oxygenation Monitor

成人光学无创脑氧合监测仪

• 批准号: 6741695
• 负责人: BO CHEN
• 金额: $ 57.57万
• 依托单位: CAS MEDICAL SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-02-01 至 2006-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6741695
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; brain; brain imaging /visualization /scanning; clinical biomedical equipment; clinical research; computer data analysis; computer program /software; gas analyzer; human subject; infrared spectrometry; mathematical model; noninvasive diagnosis; oximetry; oxygen tension; oxygen transport; patient monitoring device; respiratory oxygenation

DESCRIPTION (provided by applicant): There is a need for a non-invasive bedside monitor for adult human patients to continuously measure brain oxygenation. Near-infrared spectroscopy (NIRS) is an optically based technique that could meet such demand. However, NIRS instruments have yet to achieve their initially expected potential of becoming routine clinical monitors complementary to pulse oximetry. One major challenge is to develop an optical probe and a corresponding algorithm to solve the problem of interference from extracerebral tissue (skin, scalp, and skull) in adult NIRS applications. Another critical issue is to develop an algorithm that will be able to absolutely quantify the optical signals to derive quantitative variables or indices that are of clinical significance. Our goal is to resolve these issues by developing an NIRS monitor that will determine absolute brain hemoglobin oxygen saturation on adult patients. In Phase I, we have determined an optimum adult NIRS probe configuration to minimize extracerebral interference. We quantitatively demonstrated that the effect of extracerebral tissue oxygenation interference is reduced using a novel algorithm with experiments using the pig model, and with a preliminary human adult study. We demonstrated that our novel algorithm could determine absolute brain oxygen saturation (SnO2) with a high degree of accuracy over a full range of oxygen saturation in the pig model. The primary objectives of this SBIR Phase II proposal are: 1) To refine the design of a NIRS monitor for use on adult human patients. To construct and test improved prototypes and to determine pre-manufacturing requirements of a commercial adult NIRS monitor system. 2) To validate our NIRS monitor for measuring absolute oxygen saturation in healthy human adults.

描述（由申请人提供）：成人人类患者需要非侵入性床旁监视器来连续测量脑氧合。近红外光谱（NIRS）是一种基于光学的技术，可以满足这种需求。但是，NIRS仪器尚未达到其最初成为常规临床监测器与脉搏血氧饱和度互补的预期潜力。一个主要的挑战是开发光学探针和相应的算法，以解决成人NIRS应用中脑外组织（皮肤，头皮和头骨）干扰的问题。另一个关键问题是开发一种算法，该算法将能够绝对量化光学信号以得出临床意义的定量变量或指数。我们的目标是通过开发NIRS监测仪来解决这些问题，该监测器将确定成人患者的绝对脑血红蛋白氧饱和度。 在第一阶段，我们确定了最佳的成年NIRS探针构型，以最大程度地减少脑外干扰。我们定量地证明，使用新型算法使用PIG模型和初步的人类成人研究，使用新型算法使用新型算法来减少脑外组织氧合干扰的作用。我们证明了我们的新型算法可以在猪模型中的全范围氧饱和度上确定具有高度准确性的绝对脑氧饱和度（SNO2）。 该SBIR II期建议的主要目标是：1）完善NIRS监测仪的设计，以用于成人人类患者。构建和测试改进的原型并确定商业成人NIRS监视系统的制造前要求。 2）验证我们的NIRS监测，以测量健康的人类成年人中的绝对氧饱和度。