Minimally Invasive Cerebral Blood Flow and Oxygenation Monitoring for Intracranial Hypertension

颅内高压的微创脑血流和氧合监测

• 批准号: 10443383
• 负责人: Thomas F. Floyd
• 金额: $ 181.48万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10443383
• 关键词: Acute; Awareness; Blood flow; Brain; Brain Injuries; Cerebral hemisphere hemorrhage; Cerebrovascular Circulation; Cerebrum; Computer software; Consult; Data; Development; Device Designs; Device Safety; Device or Instrument Development; Devices; Diagnosis; Diffuse; Dura Mater; Edema; Evaluation; Family suidae; Human; Intracranial Hypertension; Ischemia; Ischemic Stroke; Location; Magnetic Resonance Imaging; Measurement; Measures; Metabolic; Modeling; Modification; Monitor; Neurological outcome; Optics; Outcome; Oxygen; Oxygen saturation measurement; Patients; Performance; Population; Resolution; Safety; Secondary to; Sensitivity and Specificity; Skin; Spectrum Analysis; Spinal Cord Ischemia; Stroke; Surface; Surveys; System; Technology; Testing; Tissues; Translating; Trauma; Traumatic Brain Injury; Trephine hole; Validation; brain tissue; cerebral oxygenation; clinical efficacy; clinical translation; cranium; design; experience; feasibility testing; first-in-human; flexibility; gray matter; improved; improved outcome; minimally invasive; monitoring device; pre-clinical; preclinical study; prototype; regional difference; safety assessment; safety testing; survival outcome; tissue oxygenation; white matter

ABSTRACT/PROJECT SUMMARY Traumatic brain injury, acute ischemic stroke, and intracerebral hemorrhage are frequently complicated by intracranial hypertension leading to progressive ischemia and secondary brain injury. Recent efforts focused on improving outcomes have therefore been focused upon improving cerebral oxygenation and the development of monitoring devices to guide therapy. Current devices designed to measure tissue oxygenation are, however, severely limited in their scope of surveillance and accuracy. Surface oximetry monitors interrogate only superficial brain tissue, with contamination from intervening skin and skull. Intraparenchymal brain tissue oxygen probes survey relatively metabolically less active white matter (compared to gray matter), a volume of less than 3 mm3, and at a single location. Lastly, intraparenchymal tissue oxygen monitors are bulky, incompatible with magnetic resonance imaging, and have yet to demonstrate clinical efficacy. To fill this need, we will finalize the development of a brain-specific, minimally invasive, optical blood flow and oxygenation monitoring system (FLOXBR), then translate this device to humans. The FLOXBR, employing diffuse optical and correlation spectroscopies via a brain surface probe, may offer improved sensitivity and specificity compared to non-invasive probes and will probe larger volumes than currently available invasive probes, such as the LicoxTM tissue pO2 probe. Unlike intraparenchymal probes, this device can lie above or below the dura and will be more sensitive to highly metabolically active gray matter. Its small size and flexibility will permit multiple probes to be placed through a single burr hole, thus allowing for the monitoring of regional differences in flow and oxygenation. Unlike surface oximetry, the FLOXBR is not impacted by superficial trauma or edema, improving reliability and sensitivity. Continuous, easily interpreted, and reliable minimally invasive monitoring of cerebral oxygen delivery may enhance management and outcomes in patients suffering from intracranial hypertension. Our aims are succinctly summarized below. Aim 1) Finalize development & manufacture the FLOXBR brain flow and oximetry monitoring device. Aim 2) Pre-clinical device evaluation, measurement validation, and safety testing of FLOXBR. Aim 3) Complete regulatory and safety requirements to support FLOXBR first-in-humans feasibility testing. Aim 4) Conduct first-in-humans feasibility testing.

摘要/项目摘要 创伤性脑损伤、急性缺血性中风和脑出血经常并发于 颅内高压导致进行性脑缺血和继发性脑损伤。最近的重点工作 因此，改善预后的重点是改善大脑的氧合能力和 开发用于指导治疗的监测设备。目前设计用于测量组织氧合的设备 然而，它们的监督范围和准确性受到严重限制。表面血氧监测仪 只审问浅表的脑组织，带有介入皮肤和头骨的污染。实质内 脑组织氧探测器检测相对代谢较少的白质(与灰质相比)， 体积小于3毫立方米，并且在单一位置。最后，实质内组织氧监测仪是 体积大，与磁共振成像不兼容，尚未证明临床疗效。 为了满足这一需求，我们将最终开发出一种特定于大脑的、微创的光学血流 和氧合监测系统(FLOXBR)，然后将这个设备移植到人类身上。FLOXBR，雇用 通过脑表面探针的漫反射光学和相关光谱可以提供更高的灵敏度和 与非侵入性探头相比的特异性，并将探测比目前可用的侵入性探头更大的体积 探针，如LICOX TM组织PO2探针。与实质内探头不同，该装置可以位于或 在硬脑膜下方，对高度代谢活跃的灰质更敏感。它的体积小，灵活性强 将允许通过单个毛刺孔放置多个探头，从而允许监测区域 在血流和氧合方面的差异。与表面血氧测定仪不同，FLOXBR不受表面创伤的影响 或水肿，提高可靠性和敏感度。连续、易于解释且可靠的微创 监测脑氧供应可能会加强对患有脑血管疾病患者的治疗和预后 颅内压升高。 我们的目标简明扼要总结如下。 目的1)完成FLOXBR脑血流和血氧监测装置的研制。 目的2)FLOXBR的临床前设备评估、测量验证和安全性测试。 目标3)完成监管和安全要求，以支持FLOXBR首次人体可行性测试。 目标4)进行第一次人类可行性测试。