Optical Detection of Intravenous Infiltration

描述（由申请人提供）：在美国，约80%的住院患者需要IV治疗，约50%的IV管路因渗透、插管中的凝块、静脉炎症反应或插管与静脉分离而失效。IV浸润通常伴有插管尖端或插入部位的疼痛、红斑和/或肿胀。严重浸润可能导致坏死，需要皮肤清创术、植皮或截肢。对医生和护士提起的医疗事故诉讼的一个常见领域涉及渗透。已知细胞毒性药物、静脉内营养、钙、钾和碳酸氢盐溶液，甚至10%葡萄糖在静脉外的泄漏会导致皮肤坏死，并在关节周围形成明显的瘢痕。浸润的早期检测可防止可能需要手术矫正的严重事件的发生。该项目的长期目标是提供一种准确、可靠和低成本的工具，以便对IV渗透进行客观评估。竞争延续工作的具体目标是：改进IV渗透检测设备，进行临床试验，并向美国食品和药物管理局提交510（k）申请。

DESCRIPTION (provided by applicant): In the United States, about 80% of hospital patients require IV therapy and about 50% of IV lines fail due to infiltration, a clot in the cannula, an inflammatory response of the vein, or separation of the cannula from the vein. IV infiltration is usually accompanied by pain, erythema, and/or swelling at the cannula tip or the insertion site. Severe infiltration may lead to necrosis requiring skin debridement, skin grafting, or amputation. One common area of malpractice lawsuits filed against physicians and nurses involves infiltration. The leakage of cytotoxic drugs, intravenous nutrition, solutions of calcium, potassium, and bicarbonate, and even 10% dextrose outside the vein into which they are delivered is known to cause skin necrosis and to precipitate significant scarring around joints. Early detection of infiltration prevents the occurrence of serious incidents that may require surgical correction. The long-term objective of the project is to provide an accurate, reliable, and low-cost tool that allows objective assessment of IV infiltrations. Specific aims of the Competing Continuation effort are: to refine the IV infiltration detection device, to conduct a clinical trial, and to submit a 510 (k) application to the U.S. Food and Drug Administration.