Endotracheal Tube Monitor for Neonates

描述（由申请人提供）：每年至少有1万例呼吸衰竭重症患儿插管使用呼吸机支持。对这些婴儿来说，插管有重大的健康风险，如气道紧急情况、心肺骤停、气胸。新生儿，无论多么年轻，都可能相当活跃，导致不希望的管移动和计划外拔管。迄今为止，没有可靠的方法来评估气管插管（ETT）的实时位置，而不需要过量的x射线辐射剂量。通过对婴儿头部和颈部的x射线进行间歇性评估来确定试管的位置，并不能实时检测到试管的错误位置。事实上，这样的评估通常在晚些时候进行，以响应床边警报，持续监测氧饱和度或通风不良。此时，气管错位的影响已经对肺的补充和气体交换产生了不利的影响。需要一种易于使用的实时传感器来指示气管内管是否已移出“良好位置”。我们建议开发一种名为气管插管监测仪（ETM）的设备，它可以检测气管插管位置的变化，并帮助护士重新定位插管。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地远程跟踪管的运动。该系统已在实验室研究和体内动物模型中成功测试。在拟议的项目中，将进一步测试和完善ETM技术。本研究的目标包括：设计、组装和验证ETM α -原型；进行ETM对ETT运动敏感性的尸体研究；并根据实验室和尸体研究的反馈设计ETM beta原型。在为期两年的研究结束时，可交付的成果包括ETM的台架验证性能、易用性、测量准确性、个人和运营商之间的差异报告，以及构建ETM II期临床研究beta原型的详细设计和文档。ETM的主要市场机会在于提高新生儿机械呼吸机支持的安全性，并大幅降低现有ETM监测方法的成本。

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.