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

使用新型凝胶麦克风的双呼吸努力和气流监测带

• 批准号: 8145959
• 负责人: MATTHEW D. TARLER
• 金额: $ 26.02万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-07-09 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8145959
• 关键词: Acoustics; Address; Adult; Airway Resistance; Algorithms; Apnea; Cannulas; Chest; Child; Childhood; Clinical Data; Clinical Research; Clinical Trials; Collection; Data; Data Collection; Data Set; Development; Devices; Diagnosis; Disease; Electronics; Face; Gel; Goals; Gold; Infant; Knowledge; Left; Measures; Membrane; Modeling; Monitor; Mouth Breathing; Neonatal; Obstruction; Output; Patient Monitoring; Patients; Performance; Phase; Population; Process; Research Personnel; Resistance; Resolution; Respiration; Respiratory Airflow; Signal Transduction; Sleep; System; Testing; Tidal Volume; Time; Tube; base; computerized data processing; data acquisition; design; digital; experience; improved; new technology; pressure; programs; prototype; respiratory; sensor; sound

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.

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，而不需要将压力插管、热传感器或其他传感器连接到患者的面部。这一新设备将解决患者在试图入睡时无法忍受或无意中将传感器从脸上移走的问题。更有问题的是，儿童、婴儿和有特殊需要的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呼吸道堵塞或阻力增加。这种新的传感器将使收集气流数据成为可能，而不需要在面部增加任何电线、管子或其他传感器。该计划将继续设计和开发这种新的传感器。虽然建造了一个初步原型，但将根据在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现实模型对新原型进行台架测试，以表征和验证新设计。然后，新的设计将被用于一项小型临床试验，以收集一组婴儿睡眠时的数据。这些婴儿将同时使用新的原型传感器和用气体测速仪监测气流的黄金标准进行双重监测。将对所有受试者进行强制呼吸暂停检查并进行记录。生成的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由此产生的算法应该被证明对儿科和特殊需要的临床医生以及对患者气流进行较少侵入性监测的研究人员具有无价的价值。 公共卫生相关性：监测儿科和新生儿人口的呼吸气流时，传感器可能会移位，不舒服，并可能导致呼吸道阻力增加。该项目将设计、制造和测试一种小型可穿戴设备，该设备将监测呼吸气流，而不需要在孩子的脸上安装压力插管或任何其他传感器。这种新传感器将为每个人的气流监测提供便利，但婴儿和新生儿人口将从新技术中受益最大。