Endotracheal Tube Monitor for Neonates

描述（由申请人提供）：每年至少有10，000名呼吸衰竭的危重婴儿接受插管呼吸机支持。对于这些婴儿来说，插管承担着重大的健康风险，如气道紧急情况，心肺骤停，气胸。新生儿，无论多么年轻，都可能非常活跃，导致不希望的管运动和计划外拔管。迄今为止，还没有一种可靠的方法来评估气管插管（ETT）的位置在真实的时间没有过量的X射线辐射剂量。通过婴儿头部和颈部的X射线进行的阶段性评估用于确定插管位置不会在真实的时间内检测到错误定位的插管。事实上，这样的评估通常很晚才进行，以响应持续监测氧气饱和度下降或通气不良的床边警报。在这一点上，管错位的影响已经对肺复张和气体交换产生了不利影响。需要一种易于使用的实时传感器，用于指示气管内导管是否已移出“良好位置”。我们建议开发一种名为气管插管监测器（ETM）的设备，可以检测气管插管位置的变化，并帮助护士重新定位气管插管。Artann实验室开发了一种原理验证光学系统，可以通过组织层精确和远程跟踪管的运动。该系统在实验室研究和体内动物模型中进行了成功测试。在拟议项目中，ETM技术将进一步测试和改进。本研究的目的包括：设计、组装和验证ETM α原型;进行ETM对ETT运动的敏感性尸体研究;根据实验室和尸体研究的反馈设计ETM β原型。两年研究结束时的可交付成果是ETM的实验室验证性能、易用性报告、测量准确性、个体和操作员之间的差异，以及为II期临床研究构建ETM beta原型的详细设计和文档。主要的ETM市场机会在于新生儿机械呼吸机支持的安全性增加以及现有ETT监测方法的成本大幅降低。 公共卫生相关性：每年至少有10，000名患有呼吸衰竭的危重婴儿接受插管呼吸机支持。对于这些婴儿来说，插管承担着主要的健康风险，例如气道紧急情况、心肺骤停和气胸。迄今为止，没有胸部放射学，还没有可靠且简单的方法来真实的时间评估气管内导管的位置。气管插管监测器（ETM）是本申请中提出的一种紧凑、廉价且易于使用的光学设备，将允许在不使用危险X射线辐射的情况下监测气管插管位置。

DESCRIPTION (provided by applicant): Each year, at least 10,000 critically sick babies in respiratory failure are intubated for ventilator support. For these babies, intubation bears major health risks such as airway emergencies, cardiopulmonary arrest, pneumothoraces. Neonates, however young, can be quite active, leading to undesirable tube movement and unplanned extubations. To date, there exists no reliable way of assessing Endotracheal Tube (ETT) position in real time without excessive X-ray radiation doses. Episodic assessment by X-rays of the baby's head and neck used to determine tube position would not detect a mal positioned tube in real time. In fact, such assessments are often performed late, in response to bedside alarms that continuous monitor for oxygen desaturations or poor ventilation. At this point, the effects of tube mal-position have already had detrimental effects on lung recruitment and gas exchange. An easy-to-use real-time sensor that indicates whether an endotracheal tube has moved out of 'good position' is needed. We propose to develop a device entitled Endotracheal Tube Monitor (ETM) that can detect the changes in the ETT position and help the nurse to reposition the tube. Artann Laboratories developed a proof-of-principle optical system that can track the motion of a tube accurately and remotely through layers of tissue. The system was successfully tested in laboratory studies and in an in vivo animal model. In the proposed project, the ETM technology will be further tested and refined. The objectives of the study include: design, assemble and validate ETM alpha-prototype; conduct cadaver studies on sensitivity of ETM to the motion of the ETT; and design ETM beta-prototype based on the feedback from the laboratory and cadaver studies. The deliverables at the end of the two year study are ETM's bench validated performances, report on ease-of-use, accuracy of measurement, and individual and operator-to- operator variations, and detailed design and documentation for building the ETM beta- prototype for Phase II clinical studies. The main ETM market opportunity is in an increased safety of neonate mechanical ventilator support and a substantial cost reduction to an existing method of ETT monitoring. PUBLIC HEALTH RELEVANCE: Each year, at least 10,000 critically sick babies in respiratory failure are intubated for ventilator support. For these babies, intubation bears major health risks such as airway emergencies, cardiopulmonary arrest and pneumothoraces, To date, there exists no reliable and easy way of assessing endotracheal tube position in real time without chest radiology. The Endotracheal Tube Monitor (ETM), a compact, inexpensive and easy-to- use optical device proposed in this application will allow endotracheal tube position monitoring without the use of hazardous X-ray radiation.