SBIR-STTR Award

This application proposes to develop a noninvasive pulmonary function test for use in infants and young children based upon the forced pressure oscillation method. Such a technique has been tested successfully in adults but has not been extensively evaluated in infants and newborns.The method is based upon the application of pressure oscillations over a range of frequencies to the airway opening or the thorax. Changes in the mechanical properties of the respiratory system alter the flow response of the respiratory system despite lack of patient cooperation or significant patient contact, and can be identified by advanced engineering techniques. A major advance is that the technique can separate airway from tissue properties. The long term goal of the application is the development of a commercially viable product.

A recent Workshop on Lung Function and Dysfunction in Infants and Children sponsored by the National Heart, Lung and Blood Institute emphasized the critical need for methods of assessing pulmonary function in infants and young children. Currently, investigators cannot assess the efficacy of therapy modalities in this patient population because there is no method for measuring their pulmonary function. In Phase I we investigated two pulmonary function tests for infants that are noninvasive, and require no patient cooperation and minimal patient contact. These tests are based on the mechanical impedance of the respiratory system which is computed from measurements of the flow response is measured at the airway opening (mouth and nose) by way of a face mask. Specific physiological parameters such as airway resistance are obtained from analysis of these data using systems identification techniques. Results from Phase I indicated that transfer impedance is very sensitive to changes in airway caliber induced by bronchoconstriction and bronchodilation in infants but input impedance is not. The long term goal of this effort is to develop a commercially available product based on transfer impedance measurements for the evaluation of pulmonary function in infants. To achieve this goal we will develop an improved prototype system (hardware and software) during the first year, and do extensive clinical evaluation of the system during the second year. PROPOSED COMMERCIAL APPLICATION: The proposed research and development will result in a unique pulmonary function test for infants and young children. This product will consist of integrated data acquisition and analysis methods that will provide information about the clinical status of the respiratory system. The need for such a test has been identified by a National Committee of Pediatric Pulmonologists.

Thesaurus Terms:
biomedical equipment development, pediatrics, respiratory function diagnosis design /evaluation, noninvasive diagnosis, respiratory airflow disorder, respiratory disorder diagnosis child (0-11), clinical research, human subject, plethysmography