Research Project
9695999
Abstract During a successful Phase 2 effort, Etiometry collaborated with multiple world-class pediatric centers to develop, validate, and deploy novel analytics that combine multiple physiologic data streams into a probabilistic assessment of inadequate oxygen delivery to critically ill patients. The analytics were integrated into the Etiometry Platform with the goal of improving physician situational awareness and preventing adverse outcomes in post-surgical pediatric cardiac patients in the ICU. During this time the platform and the analytics received FDA 510(k) clearance and were deployed in six pediatric Cardiac Intensive Care Units (CICUs). The Phase 2B effort will build on these achievements by expanding the platform?s capabilities and respective FDA cleared indications. The Etiometry Platform will integrate the new analytics into formal ICU patient care protocols that will be evaluated in a multi-center multi-arm adaptive randomization clinical trial. If successful, the results of will be used to support FDA clearance with specific claims of clinical effectiveness. The ultimate objective of the proposed SBIR effort will be demonstrate that the clinical analytics can significantly affect clinical outcomes of critically ill pediatric patients.
