Risk-based Patient Monitoring for Pediatric Cardiac Patients

NIH RePORTER · NIH · R44 · $999,708 · view on reporter.nih.gov ↗

Abstract

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.

Key facts

NIH application ID
9931264
Project number
5R44HL117340-07
Recipient
ETIOMETRY, LLC
Principal Investigator
Dimitar Valeriev Baronov
Activity code
R44
Funding institute
NIH
Fiscal year
2020
Award amount
$999,708
Award type
5
Project period
2012-07-13 → 2022-04-30