An Acoustic Respiratory Movement Sensor (ARMS) to Produce and Monitor SIMV in Inf

描述（由申请人提供）：该项目将演示将非接触式声学呼吸运动传感器（ARMS）用于一种设备的可行性，该设备将用作模块的传感器，该模块可以触发任何市售新生儿呼吸机产生非侵入性同步通气。呼吸机的同步可改善气体交换，缩短有创通气的时间，并可能减少支气管肺发育不良的发生。尽管有其优点，非侵入性同步通气并不常用，因为目前还没有商用的呼吸机使用精确的同步。同步的主要问题是用于自主呼吸的传感器。我们解决这个问题的方法是开发一种声学呼吸运动传感器（ARMS），它可以检测体表连续超声束的反射。ARMS装置的主要限制是非呼吸运动，这可能会模糊呼吸信号。我们开发了一种识别非呼吸运动的算法，该算法已通过视频观察在镇静和未遮盖的婴儿有创通气期间得到验证。在无创呼吸支持的临床环境中，婴儿通常不使用镇静剂，并由毯子覆盖。非呼吸运动算法将通过在婴儿的头部、上臂和脚踝上安装微型加速度计来验证，同时记录ARMS。ARMS算法和加速度计之间的方法间一致性将在12个早产儿中进行三个位置的测试。我们还将测量ARMS信号在检测灵感发作时的响应时间与腹压胶囊的响应时间的差异，腹压胶囊用于触发系统，该系统用于产生非侵入性SIMV (Star Sync，次声波，San Diego， CA)，已不再商业化。使用该算法，我们将评估另外12名婴儿在12-24小时内的非呼吸运动量。在这些非呼吸运动掩盖呼吸信号的记录中，ARMS的可行性将以失败率低于20%的时间来定义。这些记录将用于第二阶段生产一个模块的硬件原型，用于触发任何用于非侵入性SIMV的商业呼吸机，该模块将进行与Star Sync等效的测试，以获得FDA批准和商业化

DESCRIPTION (provided by applicant): This project will demonstrate the feasibility of the use of non-contacting acoustic respiratory movement sensor (ARMS) for a device that will be used as a sensor for a module that can trigger any commercially available neonatal ventilator to produce non-invasive synchronized ventilation. Synchronization of the ventilator improves gas exchange, decreases the length of time on invasive ventilation, and probably reduces the development of bronchopulmonary dysplasia. In spite of its advantages, non-invasive synchronized ventilation is not commonly used since there is no commercially available ventilator today that uses accurate synchronization. The main problem with synchronization is the sensor for spontaneous breathing. Our approach to this problem is the development of an acoustic respiratory movement sensor (ARMS) that detects the reflection of a beam of continuous ultrasound off the body surface. The major limitation of the ARMS device is non-respiratory movement which may obscure the respiratory signal. We have developed an algorithm for identifying non-respiratory movements that has been validated by video observation during invasive ventilation in sedated and uncovered infants. In the clinical setting of non-invasive respiratory support, infants are usually non-sedated and covered by blankets. The non-respiratory movement algorithm will be validated by attaching miniature accelerometers to the head, upper arm, and ankle of infants during simultaneous recordings of the ARMS. The inter-method agreement between the ARMS algorithm and the accelerometers will be tested in 12 premature infants in three positions. We will also measure the difference in the response times of the ARMS signal in detecting the onset of inspiration with that of an abdominal pressure capsule that is used in a trigger that was a system for producing non-invasive SIMV (Star Sync, Infrasonic, San Diego, CA) that is no longer commercially available. Using this algorithm, we will assess the amount of non-respiratory movement of 12 additional infants for 12-24 hours. Feasibility of the ARMS will be defined by a failure rate of less than 20% of the time in these recording in which non- respiratory movement obscured the respiratory signal. These recordings will be used in Phase II to produce a hardware prototype of a module for triggering any commercially ventilator for non-invasive SIMV that will be tested for equivalency to the Star Sync for FDA approval and commercialization PUBLIC HEALTH RELEVANCE: The lungs of preterm infants are easily damaged by mechanical ventilation, and synchronizing the ventilator with the infant's owns breathing helps reduce this damage. This project will help create the next generation of mechanical ventilators to further reduce this damage by synchronizing the ventilator so that it can be used non-invasively without a tube in the trachea. The new generation of ventilators will also reduce the amount of effort needed to save the premature infant and save health care costs.