SBIR Phase I: Real Time Anesthesia Monitor

该小型企业创新研究I期项目拟开发丙泊酚（2，6-二异丙基苯酚）的临床监测器，丙泊酚是一种广泛用于普外科的静脉麻醉药物，因其良好的安全性和快速起效和撤机特性而在重症监护室（ICU）中用作镇静剂。目前，丙泊酚诱导的麻醉的有效性仅通过病理学评估。两个独立的研究小组最近证明，静脉给药后人体呼出气中的丙泊酚浓度与血液浓度成正比。因此，肺丙泊酚浓度可用作闭环麻醉的控制变量。本I期项目旨在研究通过直接测量丙泊酚的特征光谱特征，使用紧凑且实时的光学装置监测肺丙泊酚浓度的可行性。这项工作将侧重于原理论证和确定该技术的最终灵敏度。 还将研究化学干扰的可能性。可靠和经济地定量丙泊酚浓度的能力也可以在丙泊酚药代动力学和许多临床研究中有广泛的应用。目前监测麻醉患者丙泊酚水平的技术是通过血液样本分析，这种技术不仅昂贵和侵入性，而且不能提供实时反馈。如果成功，拟议的工作将导致血液中丙泊酚水平的真实的时间监测，可以部署在医院，医疗中心，甚至个别医生办公室，以提高麻醉效果，降低患者突然死亡的风险。与用于检测肺丙泊酚的研究中的昂贵且笨重的质子转移质谱仪相比，预计所提出的设备更小，更便宜，更容易操作和维护，并且灵敏度相当。

This Small Business Innovation Research Phase I project proposes to develop a clinical monitor for propofol (2,6-diisopropylphenol), an intravenous anesthetic drug widely used in general surgery and as a sedative agent in the intensive care unit (ICU) because of its favorable safety profile and rapid onset and weaning characteristics. Currently, the effectiveness of propofol-induced anesthesia is only assessed symptomatically. Two independent research groups have recently demonstrated that propofol concentrations in human exhaled breath following intravenous administration are proportional to the blood concentrations. Therefore, pulmonary propofol concentrations could be used as a control variable for closed-loop anesthesia. This Phase I project proposes to study the feasibility of monitoring pulmonary propofol concentrations with a compact and real-time optical device by directly measuring the characteristic spectral features of propofol. The work will focus on a proof-of-principle demonstration and a determination of the ultimate sensitivity of the technique. The possibility of chemical interferences will also be studied. The ability to quantify propofol concentrations reliably and economically could also have broad applications in propofol pharmacokinetics and many clinical investigations.The current technique for monitoring propofol levels in anesthetized patients is by blood samples analysis; a technique that is not only expensive and invasive, but does not provide real-time feedback. If successful, the proposed work will lead to a real time monitor of propofol levels in the bloodstream that could be deployed in hospitals, medical centers and even individual physician offices in order to improve the efficacy of the anesthesia and decrease the risk of sudden patient mortality. Compared to the expensive and bulky proton transfer mass spectrometer, which has been used in research to detect pulmonary propofol, the proposed device is expected to be smaller, less expensive, easier to operate and maintain, and comparable in sensitivity.