Non-invasive neonatal respiration monitor

描述（由申请人提供）：早产一方面需要支持不成熟器官系统的技术，另一方面需要最大限度地减少可能导致长期不良结局的技术诱导损伤。这类特殊问题是动脉氧分压和二氧化碳分压的极端值。各种病理条件是 已知由低氧血症和高氧血症引起。然而，目前的理解是，可接受的PaO 2范围相当窄。类似地，低碳酸血症或高碳酸血症可导致脑或眼部病理。PaCO 2的最佳范围尚未确定，但避免极端情况对生存至关重要。因此，动脉血气（ABG）测量是必不可少的呼吸管理在新生儿重症监护病房（NICU）。但由于这些需要抽血，它们可能导致并发症，如感染，血栓形成，出血和疼痛。此外，ABG仅提供关于血气动态变化的间歇性信息。为了解决这些问题中的一些，已经使用了使用电化学传感器的O2（tcpO 2）和CO2（tcpCO 2）的经皮监测器。然而，这些电极具有许多缺点：（1）由于电解质的耗尽，它们遭受校准漂移;（2）由于Clark电极消耗O2，在低O2下缺乏灵敏度;（3）潜在的膜失效;（4）使用粘合剂来保持直接皮肤接触;（5）皮肤温度升高到43 ℃可能灼伤;（6）由于大的经皮传质阻力和基于平衡的测量而耗时。本项目的目标是开发一种基于O2和CO2光学传感的新生儿tcpO 2/tcpCO 2组合监测仪，该监测仪没有上述缺点。我们建议使用高度敏感的非侵入性光学传感器在一个独特的设计，以实现我们的目标。一个由科学家、工程师和临床医生组成的协作小组已经组建起来。第二阶段将对该器械进行进一步的临床试验。 公共卫生相关性：早产需要技术来支持不成熟的器官系统，同时最大限度地减少可能导致长期不良后果的技术引起的损伤。这类特殊问题是动脉氧分压和二氧化碳分压的极端值。已知多种病理状况是由低氧血症和高氧引起的。然而，当前的方法涉及动脉血气测量（侵入性的、疼痛的并且具有感染风险），或者需要粘附到皮肤（损伤风险）和/或加热皮肤以实现充分的气体扩散（烧伤风险）的经皮传感器。为了解决这些问题，我们计划开发一种新型经皮传感器，该传感器：（1）无创/无痛;（2）比当前传感器更准确，更安全;（3）易于工作人员使用;（4）可以更快地产生结果，以更长时间跟踪血气的动态变化。在第一阶段STTR项目结束时，我们计划证明原理，并准备在新生儿重症监护室进行更大规模的第二阶段测试。

DESCRIPTION (provided by applicant): Preterm birth requires technologies for supporting immature organ systems on one hand while minimizing technology-induced injury on the other that may contribute to long-term adverse outcomes. Specific problems of this kind are extremes in arterial partial pressure of oxygen and carbon dioxide. A variety of pathological conditions are known to result from both hypoxemia and hyperoxia. However, current understanding is that the range for acceptable paO2 is quite narrow. Similarly, hypocarbia or hypercarbia can result in brain or ocular pathology. The optimal range of paCO2 has not been established, but avoiding extremes is critical for survival. Thus, arterial blood gas (ABG) measurements are indispensable for respiratory management in the neonatal intensive care unit (NICU). But because these require the withdrawal of blood, they can lead to complications such as infection, thrombus formation, bleeding, and pain. Furthermore, ABGs provide only intermittent information concerning dynamic changes in blood gases. To address some of these concerns, transcutaneous monitors for O2 (tcpO2) and CO2 (tcpCO2) using electrochemical sensors have been used. However, these electrodes have many disadvantages: (1) They suffer from calibration drift due to depletion of the electrolyte; (2) lack of sensitivity at low O2 due to consumption of O2 by the Clark electrode; (3) potential membrane failure; (4) use of adhesives to maintain direct skin contact; (5) possible burns from raising skin temperature to 43¿C; (6) time-consuming due to large transcutaneous mass transfer resistance and equilibrium-based measurements. The goal of this project is to develop a combined tcpO2/tcpCO2 monitor for the neonate based on the optical sensing of O2 and CO2 that is free from the drawbacks mentioned above. We propose to use highly sensitive noninvasive optical sensors in a unique design to achieve our objective. A collaborative team of scientists, engineers and clinicians has been assembled. Phase II will address the further clinical testing of the device. PUBLIC HEALTH RELEVANCE: Preterm birth requires technologies for supporting immature organ systems on one hand while minimizing technology-induced injury on the other that may contribute to long-term adverse outcomes. Specific problems of this kind are extremes in arterial partial pressure of oxygen and carbon dioxide. A variety of pathological conditions are known to result from both hypoxemia and hyperoxia. However, current methodologies involve arterial blood gas measurement (invasive, painful and carries risk of infection), or transcutaneous sensors that require adhesion to the skin (injury risk) and/or heating of the skin to achieve adequate gas diffusion (risk of burns). To address these issues we plan to develop a novel trancutaneous sensor that is: (1) non-invasive/painless; (2) more accurate and much safer than current sensors; (3) easy to use by staff; (4) and can produce much faster results to follow the dynamic changes in blood gases for longer periods of time. By the end of this Phase I STTR project we plan to demonstrate proof of principle and prepare for larger scale Phase II testing in the neonatal intensive care unit.