CLINICAL TEST OF NIR/PRM SENSOR FOR HEAD INJURY DIAGNOSI

描述：(申请人摘要)本方案是进行试点 一种创新装置的临床研究：便携式伪随机调制 (PRM)和激光传感器，用于非侵入性检测和监测 创伤性脑损伤患者中的血肿。这种低成本和坚固耐用 设备易于操作和维护。该传感器可以快速、准确地 在紧急情况下诊断是否存在颅内积血 在医院内外。它在紧急情况下的效用将是 显著改善颅脑损伤患者的初始护理和管理。 建议的计划建立在我们以前使用PRM技术的经验基础上 血氧饱和度测定及初步临床阳性结果 测试。在确定了生化和光学性能特征后 由于临床应用的需要，我们将设计和开发一种仪器 其性能针对血肿检测进行了优化。它将使用特定的 脑血肿滞留/监测的临床方案和算法 以及临床试验，以满足临床诊断的准确性要求。这个 该提案的目标是开发和优化一种独特的PRM设备，并 测试该传感器样机的准确性和实用性，用于临床应用 在急诊现场无创检测和监测脑血肿， 医院急诊室和重症监护室。 建议的商业应用：不可用

DESCRIPTION: (Applicant's abstract) This proposal is to conduct a pilot clinical study of an innovative device: a portable, pseudo random modulation (PRM) and laser based sensor for non-invasive detection and monitoring of hematomas in patients with traumatic brain injuries. This low cost and robust device is easy to operate and maintain. The sensor can rapidly and accurately diagnose the presence of extravasated intracranial blood on an emergent basis outside and within the hospital. Its utility in emergency sites will significantly improve the initial care and management of head injury patients. The proposed program is built on our prior experience with PRM technology for blood oxygenation measurement and positive results of preliminary clinical tests. After defining the biochemical and optical performance characteristics needed for clinical applications, we will design and develop an instrument whose performance is optimized for hematoma detection. It will use specific clinical protocols and algorithms for brain hematoma detentions/monitoring along with clinical test to meet clinical diagnostic accuracy requirement. The objective of the proposal is to develop and optimize a unique PRM device and to test the accuracy and utility of this prototype sensor for clinical application of non-invasive brain hematoma detection and monitoring at emergency site, hospital ER and ICU. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE