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 Biomedical Technologies 及其合作者提议开发并全面测试一种低成本、便携式使用受迫振荡技术 (FOT) 的呼吸评估装置利用了新型柔性薄膜气流传感器技术。拟议的 FOT 设备对受试者的技能要求为零和操作员使其成为职业健康检查、医生办公室使用和家庭监控的理想选择。这目前准确且可重复测量肺功能的金标准是肺活量测定法。肺活量测定法是肺功能测试，测量患者最大呼气量和气流速度连接到精确空气流量计的管。肺活量计的作用由于其依赖于技术坚持。与许多医疗诊断测试不同，患者本质上是被动的参与者，肺活量测定需要患者的积极参与。该程序要求患者采取尽可能深呼吸，然后尽可能用力、尽可能长时间地呼气。测试正常情况下是重复进行以确保再现性。肺活量测定结果高度依赖于患者的合作和努力。患者经常面临显着的学习曲线。有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。与传统肺活量测定法相比，关键 FOT的临床优势在于该技术是被动的，不需要患者用力呼吸根据命令。在第一阶段，该团队将完善薄膜传感器设计并构建原型 FOT 设备。一个将进行人体研究，将原型的性能与基于商业诊所的性能进行比较示波测量装置。在第二阶段，预生产系统的所有组件将最终确定并评估人类评估中的可用性和性能。