MetaOx, Optical Monitor of Metabolic Rate of Oxygen Consumption

MetaOx，耗氧代谢率光学监测仪

• 批准号: 8334941
• 负责人: Beniamino Barbieri
• 金额: $ 24.73万
• 依托单位: ISS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-20 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8334941
• 关键词: Acute; Adult; Animal Model; Animals; Antiepileptic Agents; Biomedical Engineering; Blood flow; Boa; Boston; Brain; Brain Injuries; Bumetanide; Cardiac Surgery procedures; Caring; Cerebrovascular Circulation; Cerebrum; Clinic; Clinical; Collaborations; Computer software; Consumption; Critical Illness; Cyprinus carpio; Data Analyses; Data Quality; Detection; Development; Devices; Diagnosis; Diffuse; Diffusion; Disease; Electroencephalography; Energy Metabolism; Equilibrium; Europe; Evolution; Feedback; Frequencies; General Hospitals; Goals; Grant; Head; Health; Hemoglobin; Hospitals; Hour; Human; Hypercapnia; Infant; Injury; Intervention; Joints; Language; Magnetic Resonance Imaging; Marketing; Massachusetts; Measurement; Measures; Medical Staff; Metabolic; Metabolism; Monitor; Morbidity - disease rate; Motor; Neonatal; Neonatal Intensive Care Units; Neonatology; Neurons; Newborn Infant; Optics; Outcome; Oxygen; Oxygen Consumption; Oxygen saturation measurement; Patients; Pediatric Hospitals; Pennsylvania; Performance; Pharmaceutical Preparations; Phase; Philadelphia; Pilot Projects; Population; Positron-Emission Tomography; Research; Research Personnel; Risk; Role; Safety; Screening procedure; Seizures; Signal Transduction; Small Business Innovation Research Grant; Spectrum Analysis; System; Technology; Testing; Time; Tissues; Training; Translating; Translations; Ultrasonography; Universities; Woman; Work; clinically relevant; commercialization; data acquisition; design; fish Carp; healthy volunteer; human subject; improved; indexing; innovative technologies; instrument; instrumentation; natural hypothermia; neonate; novel; optical imaging; prototype; relating to nervous system; response; systems research; tool

DESCRIPTION (provided by applicant): ISS Inc., in collaboration with Dr. Franceschini of the Massachusetts General Hospital and Dr. Yodh of the University of Pennsylvania, proposes to develop and construct the prototype of a novel instrument to monitor cerebral oxygen metabolism (CMRO2) that combines a frequency-domain near-infrared tissue oximeter (FDNIRS) and a diffusion correlation spectroscopy (DCS) device. Combining FDNIRS and DCS will enable us to measure cerebral hemoglobin oxygenation (SO2) and an index (BFi) of cerebral blood flow (CBF) to estimate CMRO2. Our clinical collaborators Dr. Ellen Grant of Children's Hospitals in Boston, and Dr. Daniel Licht of Children's Hospital of Philadelphia will advise us on optimizing the device for the neonatal ICU clinical setting. The ability to rapidly an accurately assess cerebral metabolism at bedside in neonates is critical to improving patient management in neonatology. Currently there is no bedside tool that can accurately screen for brain injury, monitor injury evolution or assess response to therapy. Head ultrasounds are notoriously insensitive and nonspecific, EEG serves a complementary role, and MRI is too expensive and time-consuming to be used for screening or monitoring, and involves unnecessary risks of destabilizing critically ill infants who must be transported to the MRI suite. Conventional NIRS oximetry has failed to become a routine clinical tool in neonatology due to the poor sensitivity of SO2 in detecting brain injury hours after the insult, when equilibrium between oxygen delivery and consumption is reestablished. The direct measure of cerebral oxygen utilization we propose to measure with this novel instrument will provide higher sensitivity to detect brain injury and the ability to monitor normal and abnormal brain development. If successful, this device will allow for real-time interventions and thus could improve clinical outcome. Our long-term plans encompass the commercialization of the first FDNIRS/DCS cerebral metabolism monitoring system. In phase I we will build the first commercial prototype, start to develop unified acquisition and data analysis software, and test this new system in phantoms and adult human subjects. We will then perform a pilot study in newborns and compare infants with seizure activity confirmed by EEG with healthy controls, to validate the hypothesis that a measure of oxygen consumption is better able to diagnose brain damage than measure of hemoglobin oxygenation. While CMRO2 monitoring has been performed previously in a research setting, by combining ISS FDNIRS systems with lab-built DCS instrumentation, these measurements have required highly trained operators and data analysis by optical imaging experts. Our goal is to transform these cumbersome research systems into a more robust turnkey device that will enable medical staff to obtain clinically and relevant measurements at the bedside. After completion of the Phase I portion of the project, we will proceed with Phase II, during which we plan to refine the system and start demonstrating the clinical relevance of our CMRO2 measurements in three hospitals (Brigham and Women's and Children's Hospitals in Boston, and Children's Hospital of Philadelphia with Dr. Daniel Licht). If the plan is accepted in its entirety, we expect to complete development of the FDNIRS/DCS system, which we call MetaOx, within the projected four-year period. PUBLIC HEALTH RELEVANCE: Newborn brain injury causes significant morbidity. The lack of a bedside monitor for newborn brain health is hindering progress in care that could improve neurodevelopmental outcomes. The overall goal of this SBIR is to develop an instrument with which to quantify cerebral oxygen metabolism in at the bedside to be used in neonatal intensive care units. Such a device will have significant clinical utility for assessing cerebral tissue injuy and disease, and to follow response to treatment.

描述（由申请人提供）：ISS Inc.与马萨诸塞州综合医院的Franceschini博士和宾夕法尼亚大学的Yodh博士合作，提议开发和构建一种新型工具的原型，以监测脑氧代谢的原始原型（DC）设备。结合FDNIRS和DCS将使我们能够测量脑血红蛋白氧合（SO2）和脑血流量（CBF）的指数（BFI）以估计CMRO2。我们在波士顿儿童医院的临床合作者Ellen Grant博士以及费城儿童医院的Daniel Licht博士将建议我们为新生儿ICU临床环境优化该设备。快速评估新生儿床边准确评估脑代谢的能力对于改善新生儿学的患者管理至关重要。当前，没有床头工具可以准确筛选脑损伤，监测损伤的演变或评估对治疗的反应。众所周知，脑电图不敏感且非特异性，脑电图发挥了互补作用，MRI太昂贵且耗时，无法用于筛查或监测，并且涉及不必要的不​​必要的风险，即必须将必须运送到MRI Suite的严重生病的婴儿。 传统的NIRS血氧饱和度未能成为新生儿学的常规临床工具，因为SO2在侮辱后几小时检测脑损伤的敏感性不佳，当时氧气递送和消耗之间的平衡是重新建立的。我们建议使用这种新型仪器测量的脑氧利用的直接度量将提供更高的灵敏度，以检测脑损伤以及监测正常和异常脑发育的能力。如果成功，该设备将允许实时干预，从而可以改善临床结果。我们的长期计划涵盖了第一个FDNIRS/DCS脑代谢监测系统的商业化。在第一阶段，我们将构建第一个商业原型，开始开发统一的获取和数据分析软件，并在幻像和成人人类受试者中测试这个新系统。然后，我们将在新生儿进行一项试验研究，并比较脑电图证实的癫痫发作活性的婴儿与健康对照，以验证一种假设，即与血红蛋白氧气的测量相比，氧气消耗能够更好地诊断脑损伤。尽管CMRO2监测以前是在研究环境中进行的，但通过将ISS FDNIRS系统与实验室构建的DCS仪器相结合，这些测量值需要训练有素的操作员和光学成像专家的数据分析。我们的目标是将这些笨拙的研究系统转变为更强大的交钥匙设备，这将使医务人员能够在床边获得临床和相关的测量。在项目的第一阶段部分完成后，我们将继续进行第二阶段，在此期间，我们计划完善系统，并开始在三家医院（波士顿的Brigham，妇女和儿童医院）以及费城儿童医院与丹尼尔·利奇特（Daniel Licht）博士一起证明我们的CMRO2测量值的临床相关性。如果该计划全部接受，我们希望在预计的四年期内完成FDNIRS/DCS系统的开发，我们称之为Metaox。 公共卫生相关性：新生儿脑损伤会引起明显的发病率。缺乏用于新生儿大脑健康的床旁监视器正在阻碍护理的进步，这可以改善神经发育结果。该SBIR的总体目标是开发一种仪器，该仪器在床边量化脑氧代谢，以用于新生儿重症监护病房。这样的装置将具有评估脑组织不变和疾病的明显临床实用性，并遵循对治疗的反应。