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.

项目概要 急性骨筋膜室综合征 (ACS) 是由于血压升高而引起的肢体损伤的并发症。 房内压力（ICP）最终会损害灌注，导致肌肉缺血 车厢内。如果这种情况持续超过 6-8 小时，肌肉就会发生永久性缺血性损伤 （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，早期ACS诊断存在问题。外科医生 依靠临床判断和怀疑指数来诊断和做出治疗决定。由于延迟 筋膜切开术是导致不良结果的最重要因素；治疗决策偏向于 早期干预，通常会导致不必要的筋膜切开手术。由于临床结果是主观的， 尽管对于执行阈值缺乏共识，但 ICP 测量仍被普遍使用 筋膜切开术需要研究来确定诊断 ACS 的新方法。 ICP 是用于诊断 ACS 最常见的客观测试，但 ICP 并不能告诉临床医生是否 所涉及的肌肉是健康的、缺血的或坏死的，并且诊断特异性较差。目前的ICP设备 只提供单点压力测量，尽管已经表明 ICP 在整个过程中变化 隔间。此外，通过经皮针测量压力需要采样和 技术错误。这些因素导致 ICP 读数的不确定性，从而导致诊断的不确定性。 在这里，我们建议开发一种通过测量组织氧深度分布来诊断 ACS 的新方法。 受影响的肌肉。 A-Scan LLC（明尼苏达州明尼阿波利斯）开发了一种光学扫描针式探头，可扫描 pO2 沿其长度方向无机械运动。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。 从商业角度来看，ACS诊断市场源于每一个胫骨病例都考虑到ACS这一事实 断裂。考虑到美国每年发生 300,000 例胫骨骨折，市场估计为 90 美元 百万。该项目计划的第一阶段将重点验证探测器的功能和性能 大型动物模型。在未来的第二阶段扩展中，我们计划显着推进这一进程 将该设备商业化。它包括优化临床应用的设备设计、执行测试和 设备特性符合 FDA 监管要求并完成初始请求 向 FDA 提交信息（Q-提交），以获得特定的设备分类代码和途径 营销清关。