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

用于在 Inf 中生成和监控 SIMV 的声学呼吸运动传感器 (ARMS)

• 批准号: 8145731
• 负责人: Gregory P Heldt
• 金额: $ 22.26万
• 依托单位: BIODATA INNOVATION SYSTEMS, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-05 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8145731
• 关键词: Acoustics; Agreement; Algorithms; Ankle; Back; Blinded; Body Surface; Breathing; Bronchopulmonary Dysplasia; Clinical; Clinical Research; Data; Development; Devices; Environmental air flow; FDA approved; Failure; Gases; Generations; Goals; Head; Health Care Costs; Hour; Infant; Intermittent Positive-Pressure Ventilation; Intervention; Length; Lung; Masks; Measures; Mechanical Ventilators; Mechanical ventilation; Methods; Modification; Monitor; Morphologic artifacts; Movement; Neonatal; Newborn Infant; Nose; Outcome; Patients; Phase; Positioning Attribute; Premature Infant; Randomized; Reaction Time; Respiration; Respiratory Diaphragm; Respiratory System; Signal Transduction; System; Technology; Testing; Time; Trachea; Tube; Ultrasonography; Upper arm; Ventilator; abdominal pressure; base; capsule; commercialization; design; endotracheal; improved; next generation; pressure; prospective; prototype; respiratory; sensor

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.

描述（由申请人提供）：本项目将证明将非接触式声学呼吸运动传感器（ARMS）用于器械的可行性，该器械将用作模块的传感器，该模块可触发任何市售新生儿呼吸机，以产生无创同步通气。呼吸机的同步可改善气体交换，缩短有创通气时间，并可能减少支气管肺发育不良的发生。尽管无创同步通气有其优点，但由于目前没有使用精确同步的市售通气机，因此其并不常用。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），该传感器检测身体表面的连续超声束的反射。ARMS器械的主要限制是非呼吸运动，这可能会掩盖呼吸信号。我们开发了一种识别非呼吸运动的算法，该算法在镇静和未覆盖婴儿的有创通气期间通过视频观察进行了验证。在无创呼吸支持的临床环境中，婴儿通常不使用镇静剂，并用毯子覆盖。在同时记录ARMS期间，将微型加速度计连接到婴儿的头部、上臂和脚踝，以验证非呼吸运动算法。ARMS算法和加速度计之间的方法间一致性将在12名早产儿中以三种姿势进行测试。我们还将测量ARMS信号在检测吸气开始时的响应时间与腹压胶囊的响应时间之间的差异，腹压胶囊用于触发器中，该触发器是用于产生不再市售的无创SIMV（星星同步，Infrasonic，San Diego，CA）的系统。使用该算法，我们将评估另外12名婴儿12-24小时的非呼吸运动量。ARMS的可行性将通过这些记录中非呼吸运动掩盖呼吸信号的时间的故障率小于20%来定义。这些记录将用于第II阶段，以生产用于触发任何商业呼吸机进行无创SIMV的模块的硬件原型，将测试其与星星同步的等效性，以获得FDA批准和商业化 公共卫生关系：早产儿的肺部很容易受到机械通气的损害，使呼吸机与婴儿自己的呼吸同步有助于减少这种损害。该项目将有助于创造下一代机械呼吸机，通过同步呼吸机进一步减少这种损伤，以便在气管中没有管道的情况下无创使用。新一代的呼吸机还将减少拯救早产儿所需的努力，并节省医疗保健费用。

项目成果

Evaluation of Ultrasound-Based Sensor to Monitor Respiratory and Nonrespiratory Movement and Timing in Infants.

• DOI: 10.1109/tbme.2015.2466633
• 发表时间: 2016-03
• 期刊: IEEE transactions on bio-medical engineering
• 作者: Heldt GP;Ward RJ 3rd
• 通讯作者: Ward RJ 3rd