NO AND NO2 MONITOR FOR CLINICAL MEDICINE

临床医学用 NO 和 NO2 监测仪

• 批准号: 2523057
• 负责人: LARRY L SWETTE
• 金额: $ 34.55万
• 依托单位: GINER, INC.
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-05-01 至 2000-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2523057
• 关键词: biomedical equipment development; clinical biomedical equipment; clinical research; electrochemistry; electrodes; free radical oxygen; human subject; inhalation anesthesia; nitric oxide; nitrogen oxides; patient monitoring device; respirators; respiratory toxin

Goal of this project is to develop a reliable and lightweight device for real-time monitoring of NO and NO2 in the clinical environment. Nitric oxide is actively studies as a therapeutic agent in life- threatening diseases affecting neonates, children, and adults. Increasing numbers of clinical trials report successful treatment of cardiovascular and pulmonary diseases. NO is a very potent gas and administration through inhalation requires continuous monitoring. NO2, an oxidation product of NO, is highly toxic, and needs to be monitored for safety purposes. Giner, Inc.'s sensor technology will be adapted to design miniaturized electrochemical NO and NO2 sensors for incorporation into the breathing circuit. The device design will be particularly focused on the placement of sensors close to the patient, for the attachment to either the endotracheal tube, or the face mask. During Phase I in vitro feasibility of the sensor devices was successfully demonstrated regarding measurement qualities and dependence on gas flow and anesthetic interferents. In addition, the feasibility of a novel, lightweight device design was investigated, which is proposed to be developed into a prototype device during Phase II, where it will be evaluated, together with a corporate partner, regarding performance in the clinical environment. PROPOSED COMMERCIAL APPLICATION Therapeutic doses of NO for neonates, children and adults over the range 2 to 100 ppm are actively being investigated for the management of CHD and ARDS; instrumentation is required to monitor NO (and NO2, an oxidation product) in the low ppm range. The NO and NO2 instrumentation can readily be modified for environmental monitoring applications.

本项目的目标是开发一种可靠的，轻便的设备， 实时监测临床环境中的NO和NO2。 一氧化氮是积极研究作为一种治疗剂在生活中- 威胁新生儿、儿童和成人的疾病。 越来越多的临床试验报告成功治疗 心血管和肺部疾病。 NO是一种非常有效的气体， 通过吸入给药需要连续监测。 二氧化氮、 一氧化氮的氧化产物，具有很高的毒性，需要监测 为了安全起见。 Giner公司的传感器技术将适用于设计小型化 用于结合到呼吸中的电化学NO和NO2传感器 电路. 设备设计将特别关注 将传感器放置在患者附近，以便连接到 气管内导管或者面罩 在第一阶段，传感器装置的体外可行性是 成功证明了测量质量和依赖性 气体流动和麻醉剂干扰。 此外，可行性 的一种新型的，轻量级的设备设计进行了研究，这是 拟在第二阶段开发为原型器械， 将与企业合作伙伴一起进行评估， 在临床环境中的表现。 建议的商业应用 新生儿、儿童和成人的NO治疗剂量范围 正在积极研究2至100 ppm用于CHD的管理 和ARDS;需要仪器来监测NO（和NO2， 氧化产物）在低ppm范围内。NO和NO2仪器 可以容易地修改用于环境监测应用。