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（申请人提供）：ISS Inc.与马萨诸塞州总医院的 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监测脑氧代谢的新型仪器原型（CMRO2） ）结合了频域近红外组织血氧计 (FDNIRS) 和扩散相关光谱 (DCS) 装置。 FDNIRS 和 DCS 的结合将使我们能够测量脑血红蛋白氧合 (SO2) 和脑血流量 (CBF) 指数 (BFi)，以估计 CMRO2。我们的临床合作者波士顿儿童医院的 Ellen Grant 博士和费城儿童医院的 Daniel Licht 博士将为我们提供针对新生儿 ICU 临床环境优化设备的建议。床边快速准确评估新生儿脑代谢的能力对于改善新生儿科患者管理至关重要。目前还没有床边工具可以准确筛查脑损伤、监测损伤进展或评估治疗反应。众所周知，头部超声检查不敏感且非特异性，脑电图起到补充作用，MRI 太昂贵且耗时，无法用于筛查或监测，并且存在不必要的风险，可能会导致危重婴儿不稳定，必须将其送往 MRI 室。 传统的 NIRS 血氧测定法未能成为新生儿科的常规临床工具，因为在损伤后数小时（当氧气输送和消耗之间重新建立平衡时）SO2 检测脑损伤的敏感性较差。我们建议用这种新型仪器直接测量脑氧利用率，将为检测脑损伤提供更高的灵敏度，并能够监测正常和异常的脑发育。如果成功，该设备将允许实时干预，从而改善临床结果。我们的长期计划包括第一个 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，开始开发统一的采集和数据分析软件，并在人体模型和成人受试者中测试这个新系统。然后，我们将对新生儿进行一项试点研究，并将脑电图证实的癫痫活动婴儿与健康对照组进行比较，以验证耗氧量测量比血红蛋白氧合测量更能诊断脑损伤的假设。虽然 CMRO2 监测之前已在研究环境中通过将 ISS FDNIRS 系统与实验室构建的 DCS 仪器相结合进行，但这些测量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繁琐的研究系统转变为更强大的交钥匙设备，使医务人员能够在床边获得临床和相关测量结果。项目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（波士顿的布莱根妇女儿童医院和费城儿童医院（Daniel Licht 博士）。如果该计划被全部接受，我们预计将在预计的四年内完成 FDNIRS/DCS 系统（我们称之为 MetaOx）的开发。 公共卫生相关性：新生儿脑损伤会导致严重的发病率。缺乏新生儿大脑健康床边监测仪阻碍了改善神经发育结果的护理进展。该 SBIR 的总体目标是开发一种仪器，用于在床边量化脑氧代谢，以供新生儿重症监护病房使用。这种装置对于评估脑组织损伤和疾病以及跟踪治疗反应具有重要的临床实用性。