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.

项目摘要 急性骨筋膜室综合征（ACS）是一种由高血压引起的肢体损伤的并发症， 室间压（ICP），最终损害灌注，导致肌肉缺血 在车厢内。如果这种情况持续超过6-8小时，就会发生永久性的肌肉缺血性损伤 （肌纤维化和缺血性挛缩）。ACS需要立即进行筋膜切开术以恢复组织灌注， 然而，由于目前缺乏可靠的诊断标准，ACS的早期诊断是有问题的。外科医生 依靠临床判断和怀疑指数来诊断和作出治疗决定。由于拖延 筋膜切开术是导致不良结局的最重要因素;治疗决策偏向于 早期干预，往往导致不必要的筋膜切开术。由于临床结果是主观的， 尽管对执行ICP的阈值缺乏共识， 筋膜切开术研究需要确定新的方法来诊断ACS。 ICP是用于诊断ACS的最常见的客观测试，但ICP并不能告诉临床医生是否存在ACS。 受累肌肉是健康的、缺血的或坏死的，并且具有差的诊断特异性。当前ICP设备 仅提供单点压力测量，尽管已经表明ICP在整个过程中变化 车厢此外，经由经皮针的压力测量经受采样， 技术错误。这些因素导致ICP阅读的不确定性，从而导致诊断的不确定性。 在这里，我们建议开发一种新的方法来诊断ACS，通过测量组织氧的深度分布， 受影响的肌肉A-Scan LLC（Minneapolis，MN）已经开发了一种光学扫描针探头，其扫描 pO 2沿着其长度，无机械运动。在这个项目中，我们将表征设备性能 然后在复制ACS病理生理学的猪模型中进行测试。 在商业上，ACS诊断的市场来源于这样一个事实，即ACS在每个胫骨病例中都被考虑到 骨折考虑到美国每年发生30万例胫骨骨折，市场估计为90美元 万项目计划的第一阶段将重点验证探头的功能和性能， 大型动物模型。在今后的第二阶段延长中，我们计划大大推进 将该装置商业化。它包括优化临床应用的器械设计，进行测试， 符合FDA法规要求的器械表征，并完成初始申请， 向FDA提交信息（Q提交），以获得特定的器械分类代码和途径， 销售许可。