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

采用新型传感器设计的便携式低成本肺强迫振荡技术仪器

基本信息

批准号：
9347312
负责人：
Patrick Lichter
金额：
$ 22.45万
依托单位：
KORONIS BIOMEDICAL TECHNOLOGIES CORPORAT
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-06-15 至 2018-05-15
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9347312
关键词：
Accident and Emergency department Address Adherence Affect Air Airway Resistance American Asthma Biomedical Engineering Biomedical Technology Boston Cellular Phone Cessation of life Chronic Chronic Disease Clinic Clinical Companions Computer software Data Quality Development Devices Diagnostic Diagnostic tests Disease Management Electrical Engineering Emergency department visit Engineering Ensure Environment Evaluation Evaluation Studies Exhalation Face Feathers Film Focus Groups Gold Healthcare Systems Home environment Hospitalization Hospitals Human Institutes Internet Lead Learning Lung Lung diseases Managed Care Measurement Measures Mechanics Medical Medical Device Monitor Obstruction Occupational Health Oscillometry Outpatients Participant Patient Care Patient Participation Patients Performance Phase Physicians Physicians&apos Offices Procedures Production Pulmonary function tests Reproducibility Research Research Personnel Research Project Grants Respiratory Mechanics Respiratory physiology Role Science Secure Small Business Innovation Research Grant Spirometry System Techniques Technology Technology Assessment Test Result Testing Thinness Tube Universities Visit airway inflammation asthmatic patient base compliance behavior cost design design and construction experience flexibility human study instrument meter multidisciplinary new technology novel portability pressure product development professor prototype respiratory screening sensor skills trend usability verification and validation

项目摘要

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.

抽象的 Koronis生物医学技术及其合作者建议开发和完全测试低成本的便携式使用强制振荡技术（FOT）的呼吸评估设备利用了新的柔性薄膜气流传感器技术。提出的FOT设备需要对该主题为零的技能以及操作员，非常适合职业健康筛查，医师办公室使用和家庭监控。这肺功能测量值是准确且可重复测量的当前金标准。肺活量测定法是肺功能测试，测量患者可以最大地呼气到一个管子连接到精确的气流计。肺活量计的作用受到限制，因为它们依赖技术依从性。与许多医学诊断测试不同，患者本质上是被动的参与者，肺活量测定需要积极的患者参与。该过程要求患者服用尽可能最大的呼吸，然后尽可能地尽可能地呼气。测试通常是重复以确保可重复性。肺活量测量结果高度取决于患者的合作和努力。患者经常面临重要的学习曲线。有些患者无法或不会产生可解释的结果。 FOT测量肺气道的抗性和电抗。与传统肺活量测定法相反，钥匙 FOT的临床优势是该技术是被动的，并且不需要患者强烈呼吸命令。在第一阶段，团队将完善薄膜传感器设计并构建原型FOT设备。一个将进行人类研究，将原型的性能与商业诊所的表现进行比较振荡设备。在第二阶段中，预生产系统的所有组件将被敲定并评估人类评估中的可用性和绩效。