SBIR Phase I: Real-time Continuous Sensor-based Objective Scoring and Reporting of Acute Pain

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是开发一种客观测量急性疼痛的无创设备。这种疼痛测量传感器将监测病人？疼痛连续地和实时地测量，从而替代或补充了今天实践的主观疼痛测量和评分。当患者能够交流时，疼痛程度由患者主观报告。当患者无法有效沟通时，临床医生使用生命体征和面部表情等替代品主观测量疼痛程度。 这种无反应的患者包括急性监护病房、儿科的个体或患有神经系统疾病如中风和痴呆的患者。每年有多达1000万名患者接受急症护理，平均住院时间（LOS）超过10天。 改善疼痛监测可以减少LOS和减少与过度用药相关的并发症。LOS仅减少0.25天就可以每年节省50多亿美元。此外，无效的疼痛管理被认为是患者对阿片类药物成瘾的主要原因之一。在美国，阿片类药物滥用的成本超过557亿美元。 该设备的估计市场/收入机会为4.5亿美元，采用有限。拟议项目需要开发实时急性疼痛评分和报告软件平台。它将提供一个平台的开发，以实现实时疼痛评分和报告，这是一项重大努力，以证明该技术可以部署在临床环境中，医生可以很好地利用疼痛水平诊断和应用治疗计划。该平台的可行性已经通过旨在证明疼痛诱发的大脑皮层活动与相应的血液动力学反应之间的联系的研究表明。在本项目中，除了开发可用性移动的应用程序外，还将利用实时客观疼痛评估开发生物信号提取、信号调节和实时疼痛评分算法。此外，我们将对开发的平台进行验证研究。该平台的成功开发将有助于改善患者？通过降低与疼痛管理和住院时间相关的成本，该项目第二阶段的目标是使该系统电子化并加强用户界面，这是走向商业化的重要一步。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a non-invasive device to objectively measure acute pain. This pain measurement sensor will monitor patients? pain continuously and in real-time thus replacing or complementing the subjective pain measurement and scoring that is practiced today. When patients are able to communicate, pain levels are subjectively reported by the patients. When patients are unable to effectively communicate, pain levels are subjectively measured by a clinician using proxies such as vital signs and facial expressions. Such non-responsive patients include individuals in the acute care units, pediatrics, or patients suffering from neurological disorders such as stroke and dementia. Up to 10 million patients are admitted to acute care every year with an average length of stay (LOS) over 10 days. Improved pain monitoring could reduce LOS and decrease complications associated with over medication. A decrease in LOS of just 0.25 days could save over $5 billion/year. In addition, inefficient pain management is recognized as one of the major reasons patients become addicted to opiates. Opioid abuse in the US costs over $55.7 billion. An estimated market/revenue opportunity for this device is $450 million with limited adoption.The proposed project entails the development of the real-time acute pain scoring and reporting software platform. It will provide development of a platform to enable real-time pain scoring and reporting, a major effort to prove that the technology can be deployed in clinical settings where a physician can make good use of pain level diagnosis and apply a therapy plan. Feasibility of the platform has been indicated by studies aimed to prove the link between pain-evoked cortical activity of the brain and corresponding hemodynamic responses. In this project, the bio-signals extraction, signal conditioning, and real-time pain scoring algorithms will be developed utilizing real-time objective pain assessment in addition to developing a usability mobile app. In addition, we will perform validation studies of the developed platform. Successful development of the proposed platform will contribute to improving patient?s pain management significantly by lowering costs related to pain management and length of stay. The goal of phase II of the project is to miniaturize the system and enhance the user interface, an essential step towards commercialization.