Breathing Tube Position and Patency Monitoring System

描述（由申请人提供）： 该项目的长期目标是将气管内插管（ETT，呼吸管）商业化，该技术可提供大量临床相关信息，以帮助气道管理。该系统包括一个低成本的一次性ETT，其中包含几个连接到嵌入式微处理器的微型传感器。该系统可以提供：插管过程中正确插管位置的即时确认（在呼吸或非呼吸患者中）; ETT插入声带的深度的量化（在毫米范围内）; ETT腔内部分或全部阻塞的位置和程度; ETT直径与气管匹配的适当性;以及抽吸过程中吸引导管头端在ETT腔内的位置。预计该气道管理工具将通过持续监测气管插管的状况和位置，从而确保气道通畅和完整，为插管患者建立新的护理标准。这些插管的临床使用可能会降低与ETT使用相关的直接成本（例如，胸部X线检查以确认插管放置、预防性抽吸程序）和间接成本（例如，由发病率和死亡率引起的成本）。该系统的原型，它可以同样适用于成人和婴儿大小的气管插管，已在初步的动物和人类婴儿的研究与良好的结果进行了评估。然而，该原型对于临床使用来说不够坚固或微型，因此在向前推进之前需要进行额外的研究。第一阶段的关键目标是进行体外研究，以设计和开发最佳的微型系统，同时确保该设计可以低成本大规模生产。成功地完成这一目标将大大减少与第二阶段开发可靠和低成本商业系统有关的技术风险。

DESCRIPTION (provided by applicant): The long-term objective of this project is to commercialize an endotracheal tube (ETT, breathing tube) incorporating a technology which can provide a multitude of clinically relevant information to aid in airway management. The system consists of a low-cost, disposable ETT containing several miniature sensors that are connected to an embedded microprocessor. The system can provide: instantaneous confirmation of proper tube placement during intubation (in breathing or non-breathing patients); quantification of ETT insertion depth past the vocal folds to within millimeters; location and degree of partial or full obstructions within the ETT lumen; appropriateness of ETT diameter fit to the trachea; and location of a suction catheter tip within the ETT lumen during suctioning. It is expected that this airway management tool will establish a new standard of care for the intubated patient by continuously monitoring the condition and position of ETTs thereby ensuring a clear and intact airway. Clinical use of these tubes can potentially reduce both the direct costs (e.g. chest x-rays to confirm tube placement, prophylactic suctioning procedures) and indirect costs (e.g. resulting from morbidity and mortality) associated with ETT use. A prototype of the system, which can be applied equally to adult and infant sized ETTs, has been evaluated in preliminary animal and human infant studies with excellent results. However, the prototype is not robust or miniature enough for clinical use and thus requires additional research before moving forward. The key phase I aim is to conduct in vitro studies to design and develop an optimal miniature system while ensuring that the design can be mass produced at a low cost. Successful completion of this aim will significantly reduce the technology risk associated with the phase II development of a reliable and low-cost commercial system.