Innovative Method for Real-time Assessment of Intracranial Compliance

实时评估颅内顺应性的创新方法

• 批准号: 9901747
• 负责人: Robert S B Clark
• 金额: $ 43.04万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901747
• 关键词: Address; Adult; Algorithms; Bedside Technology; Blood; Blood Pressure; Blood Vessels; Brain; Carbon Dioxide; Cardiovascular system; Cause of Death; Cerebrovascular Circulation; Cerebrum; Child; Childhood Injury; Clinical; Computers; Coupled; Data; Decision Making; Development; Devices; Electronic Health Record; Guidelines; Head; Human; Impairment; Injury; Institutional Review Boards; Intervention; Intracranial Hypertension; Intracranial Pressure; Knowledge; Laws; Length of Stay; Life; Lung; Machine Learning; Measurement; Measures; Mechanical ventilation; Medical; Medicine; Methods; Modeling; Monitor; Morbidity - disease rate; Neurologic; Neurological outcome; Operative Surgical Procedures; Osmolar Concentration; Partial Pressure; Patient Care; Patient Monitoring; Patients; Pattern; Perfusion; Pharmaceutical Preparations; Physiological; Physiology; Radial; Running; Savings; Sedation procedure; Sentinel; Series; Signal Transduction; Surgical Decompression; TBI Patients; Testing; Therapeutic Intervention; Time; Titrations; Traumatic Brain Injury; Validation; Weaning; base; care outcomes; cerebral blood volume; cerebrovascular; clinical application; clinically relevant; cohort; comparative; data streams; density; improved; indexing; innovation; insight; large datasets; models and simulation; patient response; point of care; prevent; regional difference; response; signal processing; standard of care; therapeutic target; tool

"Standard of care" neurological monitoring for patients with severe traumatic brain injury (TBI) - a leading cause of death and long-term neurological impairment in children and adults-has not changed in decades, relying mainly on intracranial pressure {ICP) monitoring. Remarkably, the use of ICP alone as a therapeutic target for severe TBI is currently controversial due to a lack of robust supporting evidence, especially for its use in children. To address this clinical need, we developed the ICP-PC02 Compliance Index (ICP-PCI), an algorithm to compute dynamic intracranial compliance in real-time by integrating continuous ICP and end tidal CO, (ETC02) data streams. Bedside assessment of intracranial compliance-the relationship between changes in ICP and concomitant changes in intracranial volume, has been limited because of the lack of point-of-care devices to measure cerebral blood flow (CBF)/cerebral blood volume (CBV). The ICP-PCI is based on the well-known and robust relationship between the partial pressure of CO2 in blood (PC02) and CBV, where a change in PC02 of 1 mmHg induces an -3% change in CBF in patients with severe TBI. Since CBF is proportional to blood vessel radius to the fourth power, changes in CBF reflect immediate changes in CBV. As continuous ICP and ETC02 monitoring are standard of care for patients with severe TBI, ICP-PCI can be determined using existing ICU monitoring. To date we have obtained preliminary data in children with severe TBI in an IRB approved study that validates the physiologic premise and demonstrates feasibility for measurement of ICPPCI using existing, continuous ICU monitoring deemed guidelines-based standard of care. In this proposal, dense time series data, including continuous ETC02, ICP, and other physiologic waveforms will be interrogated. ICP-PCI will be calculated as the running moment-to-moment correlation between ETC02 and ICP across optimized temporal epochs, and subject to additional signal processing. We will confirm our findings across a larger cohort and define the temporal pattern of ICP-PCI and associations with relevant clinical variables: ICP, CPP, duration of ICP monitoring, medical and surgical interventions, and ICU and hospital length of stay. In addition, high-density, time series data will be integrated and time-synchronized with electronic health record (EHR) data and simulation models will be generated and refined to define the capacity for ICP-PCI to predict the need and response to relevant medical and surgical interventions. Clinical application of ICP-PCI will be compared head-to-head with ICP alone. Successful validation of ICP-PCI would lay the groundwork for the development of a valuable clinical tool for all Centers managing children and possibly adults with severe TBI, that could be readily integrated and implemented using existing ICU monitoring.

针对严重创伤性脑损伤 (TBI) 患者的“护理标准”神经学监测——领先 儿童和成人的死亡原因和长期神经功能障碍——几十年来没有改变， 主要依靠颅内压（ICP）监测。值得注意的是，单独使用 ICP 作为治疗方法 由于缺乏强有力的支持证据，严重 TBI 的目标目前存在争议，尤其是其使用 在儿童中。 为了满足这一临床需求，我们开发了 ICP-PC02 合规指数 (ICP-PCI)，这是一种算法 通过集成连续 ICP 和呼气末 CO 实时计算动态颅内顺应性， (ETC02) 数据流。颅内顺应性的床边评估——颅内顺应性变化之间的关系 由于缺乏护理点，ICP 和伴随的颅内容量变化受到限制 测量脑血流量（CBF）/脑血容量（CBV）的设备。 ICP-PCI 基于众所周知的 血液中 CO2 分压 (PC02) 与 CBV 之间存在稳健关系，其中变化 1 mmHg 的 PC02 会导致严重 TBI 患者的 CBF 变化 -3%。由于 CBF 正比于 血管半径的四次方，CBF 的变化反映了 CBV 的即时变化。作为连续 ICP 和 ETC02 监测是严重 TBI 患者的护理标准，ICP-PCI 可以使用以下方法确定： 现有 ICU 监护。迄今为止，我们已经获得了 IRB 中严重 TBI 儿童的初步数据 经批准的研究验证了生理前提并证明了 ICPPCI 测量的可行性 使用现有的、连续的 ICU 监测被视为基于指南的护理标准。在这个提案中， 密集的时间序列数据，包括连续的ETC02、ICP和其他生理波形将被 审问。 ICP-PCI 将计算为 ETC02 和 ETC02 之间的运行时刻相关性 跨优化时间周期的 ICP，并接受额外的信号处理。我们将确认我们的 更大队列中的研究结果，并定义 ICP-PCI 的时间模式以及与相关相关的关联 临床变量：ICP、CPP、ICP 监测持续时间、医疗和手术干预以及 ICU 和 住院时间。此外，高密度的时间序列数据将被集成并与时间同步。 将生成并完善电子健康记录（EHR）数据和模拟模型以定义容量 ICP-PCI 可以预测相关医疗和手术干预的需求和反应。临床 ICP-PCI 的应用将与单独的 ICP 进行正面比较。 ICP-PCI 成功验证 将为所有管理中心开发有价值的临床工具奠定基础 患有严重 TBI 的儿童和可能的成人，可以使用以下方法轻松整合和实施 现有 ICU 监护。