SBIR Phase I: A Novel Respiratory Bag-Valve-Mask Resuscitator

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of a novel resuscitator to ventilate patients with respiratory failure or cardiac arrest. With almost 300,000 cases of out-of-hospital cardiac arrest and approximately 350,000 in-hospital cases each year in the United States, a modest increase of just 5% in the number of patients surviving cardiac arrest would correspond to more than 33,000 additional lives saved. In 2017, the combined direct and indirect costs of deaths from out-of-hospital cardiac arrest for patients under 50 years of age to be $455 billion, with an estimate of $1.8 trillion for all deaths from cardiac arrest. On this basis, every 1% increase in the out-of-hospital cardiac arrest survival rate would result in a $4.5 billion cost saving to the United States economy.The proposed project addresses the technical challenges associated with a novel device. This Small Business Innovation Research (SBIR) Phase I project advance translation of a bag-valve-mask resuscitator that restricts the volume, pressure, and rate of ventilation to safe levels for any patient, from infant to adult. The goal of the project is to design and test a fully functioning prototype that incorporates an easy-to-use mechanism for quickly and simultaneously adjusting both the maximum volume of air delivered and the maximum pressure, and a mechanism for restricting ventilation rate. The project objectives are: (1) prototype and test a novel dial-operated mechanism for simultaneous volume and pressure control; (2) test a flow-based mechanism for restricting the ventilation rate; (3) compare the prototype performance with that of a standard bag-valve-mask resuscitator used by a group of trained medical personnel. Successful completion of this project will result in a fully functional prototype, a valuable set of data on the device performance, and important feedback from end-users on design, ease of use, and device functionality to inform future modifications. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.