Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors

呼出气中的异丙酚：表面声波传感器实时检测

• 批准号: 8314868
• 负责人: DONN MICHAEL DENNIS
• 金额: $ 16.11万
• 依托单位: XHALE, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-10 至 2014-09-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314868
• 关键词: Acoustics; Anesthesia procedures; Anesthetics; Antiemetics; Applications Grants; Blood; Carbon Dioxide; Characteristics; Chemical Structure; Chromatography; Clinical; Collection; Colonoscopy; Conscious; Department of Defense; Detection; Development; Devices; Dose; Drowsiness; Environmental air flow; Equipment; Esophagus; Exhalation; Feeling; Florida; Gas Chromatography; Germany; Goals; Hospitals; Human; Human Resources; Hypoxia; Intellectual Property; Intravenous; Intravenous Anesthetics; Isoflurane; Japan; Licensing; Lung; Magnetic Resonance Imaging; Marketing; Mass Spectrum Analysis; Measurement; Measures; Medical; Military Personnel; Minor; Molecular; Nitrous Oxide; Operative Surgical Procedures; Oxygen; Patient Care; Patients; Personal Satisfaction; Plasma; Polymers; Price; Procedures; Propofol; Protons; Reaction; Reflex action; Research; Research Personnel; Residual state; Scanning; Sedation procedure; Specificity; Surface; Techniques; Technology; Testing; Time; Trachea; Tube; Unconscious State; United Kingdom; United States; Universities; base; clinically relevant; commercialization; computerized data processing; desflurane; design; detector; endotracheal; improved; innovation; nerve agent; new technology; patient safety; point of care; prevent; prototype; sensor; sevoflurane; surface coating; tool

DESCRIPTION (provided by applicant): Propofol endures as the most popular intravenous (IV) anesthetic due to several favorable characteristics. Anesthesia personnel customarily measure the concentrations in breath of many agents used during surgery including: molecular oxygen to prevent hypoxia, carbon dioxide to assure placement of an endotracheal tube in the trachea and adequate ventilation, and anesthetics (e.g., desflurane, nitrous oxide) to maintain the appropriate "level of consciousness"/depth of anesthesia. Recently, several independent research teams have demonstrated that patients receiving IV propofol eliminate a fraction of this anesthetic in the breath. Also, the concentration of propofol in breath correlates to and is therefore predictive of its free blood concentration. Therefore, the possibility exists to determin and manipulate the blood concentration of propofol using real-time, point-of-care measurement of exhaled propofol levels to guide its dosing. This ability will be similar to techniques already employed for volatile anesthetics and will improve patient safety. Unfortunately, the current research tools (e.g., proton transfer reaction-mass spectroscopy [PTR-MS], gas chromatography- mass spectroscopy [GC-MS]) used to measure propofol in breath consists of sensitive, large, very expensive equipment that requires skilled, personnel to operate. Clearly, the development of novel technology that is small, robust, reliable, and easily operated for measuring exhaled propofol levels is a prerequisite for clinical acceptance. The goal of this grant proposal is to design, build, and test a prototype device to measure exhaled propofol. The innovation of this application is leveraging previous development by the Department of Defense by adapting polymer coated surface acoustic wave (SAW) technology to detect propofol at clinically relevant concentrations. To this end, the following specific aims will be achieved: Aim 1: Design and build a SAW detector with improved circuitry, miniature valving, an improved collection tubing to patient, and CO2-gated collection (4 months). Aim 2: Measure and compare propofol concentrations in exhaled breath (using SAW and conventional GC- MS) to those in plasma (using UPLC) in human patients (n=15) anesthetized with propofol. (8 months) The short term objective of Xhale, Inc. is to research and develop these devices for later introduction into the US market, projected to exceed $341 million by 2013. PUBLIC HEALTH RELEVANCE: Propofol endures as a commonly used intravenous anesthetic and has recently been demonstrated to emanate from the lung in concentrations proportionate to blood concentrations. The goal of this project is to design, build, and test a prototype device to measure exhaled propofol in order to estimate human blood concentrations in real-time and to improve the safety of patients anesthetized with this agent.

描述(由申请人提供)：异丙酚由于几个良好的特性一直是最受欢迎的静脉(IV)麻醉剂。麻醉人员通常会测量手术中使用的许多药物的呼气浓度，包括：防止缺氧的分子氧，确保气管内插管和充分通风的二氧化碳，以及维持适当的“意识水平”/麻醉深度的麻醉剂(如地氟烷、一氧化二氮)。最近，几个独立的研究小组证明，接受丙泊酚静脉注射的患者在呼吸中消除了这种麻醉剂的一小部分。此外，异丙酚在呼气中的浓度与其游离血浓度相关，因此可以预测其游离血浓度。因此，有可能通过实时测量呼出的异丙酚浓度来确定和控制异丙酚的血药浓度，以指导其给药。这种能力将类似于已经用于挥发性麻醉剂的技术，并将提高患者的安全性。不幸的是，目前用于测量呼气中异丙酚的研究工具(例如，质子转移反应-质谱仪[PTR-MS]、气相色谱-质谱仪[GC-MS])由敏感、大型、非常昂贵的设备组成，需要熟练的人员进行操作。显然，开发小、坚固、可靠和易于操作的新技术来测量呼出的异丙酚浓度是临床接受的先决条件。这项拨款提案的目标是设计、建造和测试一个原型设备来测量呼出的异丙酚。这项应用的创新是利用国防部之前的开发，采用聚合物涂层表面声波(SAW)技术来检测临床相关浓度的异丙酚。为此，将实现以下具体目标：目标1：设计和制造一个经过改进的电路、微型阀门、改进的病人收集管和二氧化碳门控收集(4个月)的声表面波探测器。目的：用声表面波(SAW)和常规气相色谱-质谱仪(GC-MS)分别测定15例异丙酚麻醉患者呼气和血浆中异丙酚的浓度，并进行比较。(8个月)Xhale，Inc.的短期目标是研究和开发这些设备，以便以后推出 进入美国市场，预计到2013年将超过3.41亿美元。 公共卫生相关性：异丙酚作为一种常用的静脉麻醉剂持续存在，最近被证明是从肺中排出的浓度与血液浓度成比例。该项目的目标是设计、制造和测试一种测量呼出异丙酚的原型装置，以便实时估计人体血药浓度，并提高使用该药麻醉的患者的安全性。