Portable Low-Cost Pulmonary Forced Oscillation Technique Instrument Using a Novel Sensor Design

摘要 Koronis Biomedical Technologies及其合作者提议开发并全面测试一种低成本、便携的 使用强迫振荡技术(FOT)的呼吸评估设备，利用 新型柔性薄膜空气流量传感器技术。建议的FOT设备对受试者来说不需要任何技能 和操作员，使其成为职业健康筛查、医生办公室使用和家庭监控的理想选择。这个 目前精确和可重复测量肺功能的金标准是肺活量测定法。肺活量测定法是一种 肺功能测试，测量患者最大呼气量和最大呼气量 连接在精密空气流量计上的管子。肺活量计的作用受到限制，因为它们依赖于 技术坚持。与许多医学诊断测试不同的是，患者基本上是被动的 参与者，肺活量测定需要患者积极参与。这一程序要求患者服用 尽可能深吸一口气，然后尽可能用力地呼气，尽可能长时间地呼气。测试通常是 重复使用以确保重现性。肺活量测定的结果高度依赖于患者的合作和努力。 患者通常面临着一条重要的学习曲线。一些患者不能或不会产生可解释的结果。 FOT测量肺气道阻力和电抗。与传统的肺活量测定法相比，关键是 FOT的临床优势在于该技术是被动的，不需要患者用力呼吸。 听从指挥。在第一阶段，该团队将改进薄膜传感器设计并构建FOT设备原型。一个 将进行人体研究，将原型的性能与基于商业诊所的性能进行比较 振荡器。在第二阶段，将最后确定生产前系统的所有组成部分，并对其进行评估 人类评估中的可用性和性能。

Abstract Koronis Biomedical Technologies and its collaborators propose to develop and fully test a low-cost, portable respiratory assessment device using the forced oscillation technique (FOT) leveraging the development of a new flexible thin-film airflow sensor technology. The proposed FOT device requires zero skill for the subject and operator making it ideal for occupational health screening, physician office use, and home monitoring. The current gold standard for accurate and repeatable measurement of lung function is spirometry. Spirometry is a pulmonary function test that measures the volume and rate of air flow a patient can maximally exhale into a tube attached to a precise air-flow meter. The role of spirometers has been limited due to their reliance on technique adherence. Unlike many medical diagnostic tests where the patient is essentially a passive participant, spirometry requires active patient participation. The procedure requires the patient to take the deepest breath possible, and then exhale as hard as possible, for as long as possible. The test is normally repeated to ensure reproducibility. Spirometry results are highly dependent on patient cooperation and effort. Patients often face a significant learning curve. Some patients cannot, or will not, produce interpretable results. FOT measures pulmonary airway resistance and reactance. In contrast to traditional spirometry, the key clinical advantage of FOT is that the technique is passive and does not require the patient to breathe forcefully on command. In Phase I, the team will refine a thin-film sensor design and construct a prototype FOT device. A human study will be conducted, comparing the performance of the prototype to a commercial clinic-based oscillometry device. In Phase II, all components of the pre-production system will be finalized and evaluated for usability and performance in human evaluations.