Tissue Oxygen Scanning for Acute Compartment Syndrome (ACS) Diagnosis

组织氧扫描用于急性筋膜室综合征 (ACS) 诊断

• 批准号: 10697253
• 负责人: Shai Ashkenazi
• 金额: $ 27.61万
• 依托单位: ASCAN L. L. C.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697253
• 关键词: Acute; Affect; Algorithms; Animal Model; Certification; Classification; Clinical; Code; Compartment syndromes; Complication; Consensus; Contracture; Databases; Dependence; Device Designs; Devices; Diagnosis; Diagnostic; Diagnostic Specificity; Dissociation; Early Diagnosis; Early Intervention; FDA approved; Family suidae; Fracture; Functional disorder; Future; Health; Hindlimb; Hospitalization; Hour; Hypoxia; Incidence; Injury; Ischemia; Isolated limb perfusion; Joints; Judgment; Length; Malignant Neoplasms; Marketing; Measurement; Measures; Mechanics; Methods; Movement; Mus; Muscle; Myoglobin; Necrosis; Needles; Operative Surgical Procedures; Optics; Outcome; Oxygen; Pathway interactions; Performance; Perfusion; Phase; Positioning Attribute; Procedures; Process; Property; Reading; Reporting; Research; Sampling; Sampling Errors; Scanning; Site; Small Business Innovation Research Grant; Specific qualifier value; Speed; Surgeon; Temperature; Testing; Tissue Viability; Tissues; Tourniquets; Ultrasonography; Uncertainty; Unnecessary Surgery; bone; brain tissue; cerebral oxygenation; clinical application; commercialization; design; diagnostic accuracy; high risk; improved; in vivo; in vivo evaluation; indexing; limb injury; novel; performance tests; porcine model; pressure; statistics; tibia; tissue injury; tissue oxygenation; tumor

PROJECT SUMMARY Acute compartment syndrome (ACS) is a complication of extremity injury caused by increasingly elevated intracompartmental pressure (ICP) that eventually compromises perfusion, causing ischemia of the muscles within the compartment. If this persists longer than 6-8 hours, permanent ischemic damage to the muscle occurs (myofibrosis and ischemic contracture). ACS demands immediate surgical fasciotomy to restore tissue perfusion, yet early ACS diagnosis is problematic because of the current lack of a reliable diagnostic standard. Surgeons rely on clinical judgment and index of suspicion to diagnose and make treatment decisions. Since delayed fasciotomy is the most important factor contributing to poor outcomes; treatment decisions are biased towards early intervention, often leading to unnecessary fasciotomy procedures. Since clinical findings are subjective, measurement of ICP is commonly used despite lack of consensus regarding a threshold for performing fasciotomy Research is needed to identify new methods to diagnose ACS. ICP is the most common objective test used to diagnose ACS, but ICP does not tell the clinician whether the involved muscles are healthy, ischemic, or necrotic, and has poor diagnostic specificity. Current ICP devices provide only a single-point pressure measurement, although it has been shown that ICP varies throughout the compartment. Furthermore, measurement of pressure via a percutaneous needle is subject to sampling and technical error. These factors contribute to uncertainty about the ICP reading and therefore the diagnosis. Here we propose developing a new method to diagnose ACS by measuring a depth profile of tissue oxygen in the affected muscle. A-Scan LLC (Minneapolis, MN) has developed an optical scanning needle probe that scans pO2 along its length without mechanical movement. In this project we will characterize the device performance and then test it in a swine model that replicates the pathophysiology of ACS. Commercially, the market of ACS diagnosis is derived from the fact that ACS is considered in every case of tibia fracture. Considering an annual incidence of 300,000 tibia fractures in the US, the market is estimated at $90 million. This phase I of the project plan will focus on validating the functionality and performance of the probe in a large animal model. In a future phase II extension we plan to significantly advance the process of commercializing the device. It includes optimizing the device design for clinical application, perform testing and device characterization for complying with FDA regulatory requirements and complete an initial request for information (Q-Submission) to the FDA in order to obtain a specific device classification code and a pathway to marketing clearance.

项目总结 急性脑室间隔综合征(Acs)是一种肢体损伤的并发症，其原因是 室内压(ICP)，最终影响血流灌注，导致肌肉缺血 在车厢里。如果这种情况持续6-8小时以上，肌肉就会发生永久性的缺血性损伤。 (肌纤维化和缺血性肌挛缩)。急性冠脉综合征要求立即手术切开筋膜以恢复组织灌注， 然而，由于目前缺乏可靠的诊断标准，早期诊断ACS是有问题的。外科医生 依靠临床判断和怀疑指数进行诊断和治疗决策。自延迟以来 筋膜切开术是导致不良结果的最重要因素；治疗决定偏向于 早期干预，往往导致不必要的筋膜切开手术。由于临床表现是主观的， 尽管对实施的门槛缺乏共识，但对颅内压的测量是常用的 需要进行筋膜切开术研究，以确定诊断急性冠脉综合征的新方法。 颅内压是诊断急性冠脉综合征最常见的客观检查，但并不能告诉临床医生 受累肌肉是健康的、缺血的或坏死的，诊断特异性较差。当前的电感耦合等离子体器件 仅提供单点压力测量，尽管已显示在整个 车厢。此外，通过经皮针测量压力需要取样和 技术错误。这些因素造成了对比较方案读数的不确定性，因此也造成了诊断的不确定性。 在这里，我们建议开发一种新的方法来诊断急性冠脉综合征，通过测量组织氧的深度剖面 受影响的肌肉。A-Scan LLC(明尼阿波利斯，明尼苏达州)已经开发出一种光学扫描针头，可以扫描 PO2沿其长度方向，无需机械运动。在这个项目中，我们将描述设备的性能 然后在复制急性冠脉综合征病理生理学的猪模型中进行测试。 在商业上，ACS诊断的市场源于这样一个事实，即在每一个胫骨病例中都考虑到了ACS 骨折。考虑到美国每年30万例胫骨骨折的发病率，这一市场的价格估计为90美元 百万美元。项目计划的第一阶段将侧重于验证探测器的功能和性能 一个大型动物模型。在未来的第二阶段扩展中，我们计划大幅推进 将该设备商业化。它包括为临床应用优化设备设计，执行测试和 符合FDA法规要求的设备表征，并完成初始请求 向FDA提交信息(Q-提交)，以获得特定的设备分类代码和路径 营销许可。