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，而无需将压力套管，热传感器或其他传感器连接到患者的脸上。这种新设备将解决患者在睡觉时无法忍受或无意中从脸上取下传感器的问题。更有问题的是，儿童、婴儿和有特殊需要的人群可能不耐受压力插管，甚至更糟的是，压力插管实际上会导致气道阻塞或阻力增加。这种新型传感器将能够收集气流数据，而无需在脸上添加任何电线、管道或其他传感器。该项目将继续设计和开发这种新型传感器。虽然建立了一个初始原型，但基于在初步数据收集中获得的经验和知识，将应用许多改进。然后将使用呼吸模拟器和现实模型对新原型进行台架测试，以表征和验证新设计。这项新设计将用于一项小型临床试验，收集一组婴儿睡觉时的数据。这些婴儿将使用新的原型传感器和用气记录仪监测气流的金标准进行双重监测。将对所有受试者进行强制呼吸并进行记录。结果数据集将用于进一步改进算法和数据处理，以进一步改善传感器输出。传感器的最终配置和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来说是非常宝贵的，可以对患者气流进行微创监测。

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.