TrachAlarm: A novel, low-cost accessory to automatically detect and alert caregivers to tracheostomy tube decannulation

TrachAlarm：一种新颖的低成本配件，可自动检测气管切开插管并提醒护理人员

• 批准号: 10082153
• 负责人: VINAY M NADKARNI
• 金额: $ 21.61万
• 依托单位: INNOVATIONS UNLIMITED, LLC
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-17 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10082153
• 关键词: Adverse event; Agreement; Algorithms; Caregivers; Cessation of life; Clinical; Computer software; Development; Device Designs; Device Safety; Devices; Effectiveness; Electronics; Ensure; Event; Feedback; Future; Health care facility; Healthcare; Home environment; Hospitals; Individual; Instruction; Intelligence; Intuition; Label; Licensing; Life; Location; Magnetism; Manufacturer Name; Medical Device; Modification; Movement; Neck; Patients; Performance; Phase; Population; Positioning Attribute; Power Sources; Procedures; Production; Regulation; Respiration; Risk; Running; Safety; Sales; Sensitivity and Specificity; Shipping; Small Business Innovation Research Grant; Specificity; Sterile coverings; Stomas; Surveys; System; Target Populations; Technology; Testing; Time; Trachea; Tracheostomy Tube; Tracheostomy procedure; Tube; Update; Ventilator; Visual; Wireless Technology; cost; demographics; design; engineering design; improved; innovation; innovative technologies; large scale production; light weight; magnetic field; novel; operation; prevent; prototype; sensor; socioeconomics; success; usability

Tracheostomy provides a critical, life-supporting function for over 6.5 million individuals in the U.S. with over 110,000 new procedures each year. The TrachAlarm is a novel, low-cost accessory to automatically detect and alert caregivers when a tracheostomy tube is accidentally removed from a patient. It provides a low-cost, accessible solution for tracheostomy patients and caregivers by utilizing magnetic sensing and smart alarms. The system integrates magnetic sensors in the patient dressing, and an alarm unit that easily connects to a tracheostomy flange and trach-tie. When the dressing is placed on the patient’s neck, magnetic sensors automatically align (around the periphery of the stoma) with the trachea insertion location. The alarm unit includes circuitry to detect the magnetic field. If the tube is moved away from the trachea, the alarm unit moves along with it, removing the detected magnetic field, creating an audible and visual alarm for the caregiver. Significant innovations distinguish the TrachAlarm from other market technologies. First, existing sensors and alarms are only available on ventilators that may be connected, but not for patients not requiring ventilators. Second, magnetic field technology provides a low-cost, low-burden device, easy for caregivers to use. These features will greatly improve technology accessibility to wide ranging demographics and socioeconomic disparate populations. Finally, accurate and automated alarms provide a significant benefit to patients by improving safety and preventing adverse events with overall burden to caregivers reduced. Phase II will expand upon successful Phase I prototype results to launch a commercially and clinically deployable TrachAlarm. The project is strategically positioned with four main objectives over a two-year period with specific tasks and success milestones. Aim 1 will use Phase I results to optimize device components, system packaging and alarm delivery. This includes finalizing all electronic components, device form factor, and developing all system packaging, user guides, and labeling for shipping and use. This task will enhance device safety and effectiveness by extending the on-device alarm to wireless mobile alarming. All modifications and additions will be technically verified by formal test cases. Aim 2 will target algorithmic enhancements to the alarming strategy to optimize both sensitivity and specificity. While the device requires 100% sensitivity, it is critical high specificity is also achieved to ensure users respond to the alarm when it occurs. Aim 3 will transition all engineering designs to formal manufacturing and quality procedures. This will include scaling the design for large scale production, minimizing costs, supplier assessments, and assembly instructions. A pre-production run of devices using the full-scale manufacturing procedures will be tested as per all required input specifications, medical device standards, and quality regulations. Finally, Aim 4 will complete a final update to any device design or manufacturing procedures and produce first article devices. These devices will be implemented in a large- scale field usability study to determine performance, effectiveness, and safety in the target user population.

气管切开术为美国超过650万人提供了关键的生命支持功能， 每年11万例新手术。TrachAlarm是一种新颖的低成本配件，可自动检测和 当气管造口管意外地从患者身上移除时，提醒护理人员。它提供了一种低成本， 通过利用磁感应和智能报警，为气管切开术患者和护理人员提供了一个易于使用的解决方案。 该系统在患者敷料中集成了磁传感器，以及一个易于连接到 气管切开凸缘和气管扎带。当敷料被放置在患者的颈部时， 自动与气管插入位置对齐（围绕造口的周边）。报警单元包括 检测磁场的电路。如果管从气管移开，报警单元沿着移动 它消除检测到的磁场，为护理人员创建听觉和视觉警报。 TrachAlarm的重大创新使其有别于市场上的其他技术。首先，现有的传感器 并且警报仅在可能连接的呼吸机上可用，但不适用于不需要呼吸机的患者。 其次，磁场技术提供了一种低成本、低负担的设备，便于护理人员使用。这些 功能将大大提高技术可访问性，以广泛的人口统计和社会经济 不同的人群最后，准确和自动化的警报为患者提供了显著的益处， 提高安全性并预防不良事件，同时减轻护理人员的总体负担。 第二阶段将在第一阶段原型成功的基础上进行扩展， 可部署TrachAlarm。该项目的战略定位是在两年期间实现四个主要目标 具体任务和成功里程碑。目标1将使用第一阶段的结果来优化器械组件、系统 包装和报警交付。这包括最终确定所有电子组件、设备外形尺寸， 开发所有系统包装、用户指南和标签，以便运输和使用。这项任务将增强设备 通过将设备上的报警扩展到无线移动的报警来提高安全性和有效性。所有修改和 将通过正式测试用例对新增内容进行技术验证。Aim 2将针对 令人担忧的策略，以优化灵敏度和特异性。虽然该设备需要100%的灵敏度，但它 还实现了临界高特异性，以确保用户在警报发生时对其作出响应。Aim 3将转型 所有工程设计都符合正式的制造和质量程序。这将包括扩展设计， 大规模生产，最大限度地降低成本，供应商评估和组装说明。一个预生产运行 将按照所有要求的输入质量标准对使用全规模生产程序的器械进行试验， 医疗器械标准和质量法规。最后，Aim 4将完成对任何设备设计的最终更新 或制造程序并生产首件装置。这些设备将在一个大的- 规模现场可用性研究，以确定目标用户人群的性能、有效性和安全性。