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.
Asthma is a major chronic disease that affects 34 million Americans and presents an enormous burden to the healthcare system. The condition is responsible for one quarter of all emergency room visits in the U.S. In 2004, there were 14.7 million outpatient asthma visits to physicians? offices, 1.8 million visits to emergency departments for asthma, 497,000 asthma hospitalizations, and 4,055 deaths. It is well-accepted in the management of asthma that chronic monitoring for worsening inflammation of airways is important. A low-cost lung function assessment technology that requires minimal effort to operate properly would fill an unmet need in the management of this disease.
