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

Abstract Koronis Biomedical Technologies and its collaborators propose to develop and fully test a low costportable respiratory assessment device using the forced oscillation techniqueFOTleveraging the development of a new flexible thin film airflow sensor technologyThe proposed FOT device requires zero skill for the subject and operator making it ideal for occupational health screeningphysician office useand home monitoringThe current gold standard for accurate and repeatable measurement of lung function is spirometrySpirometry 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 meterThe role of spirometers has been limited due to their reliance on technique adherenceUnlike many medical diagnostic tests where the patient is essentially a passive participantspirometry requires active patient participationThe procedure requires the patient to take the deepest breath possibleand then exhale as hard as possiblefor as long as possibleThe test is normally repeated to ensure reproducibilitySpirometry results are highly dependent on patient cooperation and effortPatients often face a significant learning curveSome patients cannotor will notproduce interpretable resultsFOT measures pulmonary airway resistance and reactanceIn contrast to traditional spirometrythe key clinical advantage of FOT is that the technique is passive and does not require the patient to breathe forcefully on commandIn Phase Ithe team will refine a thin film sensor design and construct a prototype FOT deviceA human study will be conductedcomparing the performance of the prototype to a commercial clinic based oscillometry deviceIn Phase IIall components of the pre production system will be finalized and evaluated for usability and performance in human evaluations Narrative Asthma is a major chronic disease that affectsmillion Americans and presents an enormous burden to the healthcare systemThe condition is responsible for one quarter of all emergency room visits in the U SInthere weremillion outpatient asthma visits to physiciansofficesmillion visits to emergency departments for asthmaasthma hospitalizationsanddeathsIt is well accepted in the management of asthma that chronic monitoring for worsening inflammation of airways is importantA low cost lung function assessment technology that requires minimal effort to operate properly would fill an unmet need in the management of this disease