Dual Respiratory Effort and Airflow Monitor Belt using a new gel microphone

描述（由申请人提供）：拟议项目的目标是开发和验证一种能够记录呼吸气流的新设备，而无需将压力插管、热传感器或其他传感器连接到患者面部。这款新设备将解决患者在尝试睡觉时无法忍受或无意中将传感器从脸上取下的问题。更成问题的是，儿童、婴儿和特殊需要人群可能无法忍受压力插管，或者更糟糕的是，压力插管实际上会导致他们的气道阻塞或阻力增加。这种新传感器将能够收集气流数据，而无需在脸上添加任何电线、管子或其他传感器。该计划将继续这种新型传感器的设计和开发。尽管构建了初始原型，但仍将根据初步数据收集中获得的经验和知识进行许多改进。然后，将使用呼吸模拟器和真实模型对新原型进行台架测试，以表征和验证新设计。然后，新设计将用于一项小型临床试验，以收集一组婴儿睡眠时的数据。这些婴儿将通过新的原型传感器和呼吸速度描记器监测气流的黄金标准进行双重监测。所有受试者都将进行强迫呼吸暂停并进行记录。然后，所得数据集将用于进一步完善算法和数据处理，以进一步改进传感器输出。传感器的最终配置和由此产生的算法对于儿科和特殊需要的临床医生以及研究人员对患者气流的微创监测具有无价的价值。 公共卫生相关性：儿科和新生儿群体呼吸气流的监测会受到传感器的影响，这些传感器可能会移位、不舒服，并且可能导致气道阻力增加。该项目将设计、构建和测试一种小型可穿戴设备，该设备将监测呼吸气流，而无需在儿童脸上安装压力插管或任何其他传感器。这种新传感器将有利于每个人的气流监测，但婴儿和新生儿群体将从新技术中获益最多。

DESCRIPTION (provided by applicant): The goal of the proposed project is to develop and validate a new device capable of recording the respiratory airflow without the need for a pressure cannula, thermal sensor or other sensor being attached to a patient's face. This new device will address the problem of patients not tolerating or inadvertently removing the sensor from their face while they try to sleep. Even more problematic is that the pressure cannula may not be tolerated by children, infants, and the special needs population, or even worse, the pressure cannula can actually cause obstruction or increased resistance to their airway. This new sensor will enable the collection of airflow data without the addition of any wires, tubes or other sensors on the face. This program will continue the design and development of this new sensor. Although an initial prototype was constructed, many improvements will be applied based on the experiences and knowledge gained in the preliminary data collection. A new prototype will then be bench tested using respiratory simulators and realistic models to characterize and verify the new design. The new design will then be used in a small clinical trial to collect data from a set of infants while they sleep. These infants will be dual monitored with both the new prototype sensor and the gold standard for monitoring airflow with a pneumotachograph. Forced apneas will be performed and recorded from all of the subjects. The resulting data set will then be used to further refine the algorithms and data processing to further improve the sensor output. The final configuration of the sensor and the resulting algorithms should prove to be invaluable to pediatric and special needs clinicians as well as researchers for less invasive monitoring of patient airflow. PUBLIC HEALTH RELEVANCE: The monitoring of respiratory airflow in pediatric and neonatal populations suffers from sensors that can be dislodged, are uncomfortable, and can cause increased airway resistance. This program will design, build and test a small wearable device that will monitor respiratory airflow without the need for a pressure cannula or any other sensors on the child's face. This new sensor will facilitate airflow monitoring for everyone, but the infant and neonatal population will have the most to gain from the new technology.