Risk Assessment Using Noninvasive Measurements in Postoperative Pediatric Patients

 描述（由申请人提供）：在一项成功的第1阶段研究中，Etiometry和波士顿儿童医院开发了一种新型风险监测系统（RMS），以协助脆弱且具有临床挑战性的新生儿人群的术后护理：患有先天性心脏缺陷手术的婴儿。该系统综合集成了多种生理信号，以提取并真实的实时传递有关患者生理状态的可操作信息，从而支持有效和及时的干预。第二阶段的工作将部署和整合该系统到临床工作流程在波士顿儿童医院，儿童国家医疗中心在华盛顿特区，儿童医院（多伦多）和圣路易斯儿童医院，并评估其对护理过程和患者结局的影响。此外，Etiometry还将与费城儿童医院（CHOP）模拟、高级教育和创新中心合作，测试该系统用户体验（UX）的安全性、有效性、可用性和性能特征，并对其进行改进，以优化其临床实用性。拟议SBIR努力的最终目标将证明RMS可以显著影响先天性心脏病术后新生儿护理的质量和成本。

 DESCRIPTION (provided by applicant): During a successful Phase 1 effort, Etiometry and Boston Children's Hospital developed a novel Risk Monitoring System (RMS) to assist with the postoperative care of a vulnerable and clinically challenging neonatal population: infants with surgery for congenital heart defects. The system comprehensively integrates multiple physiologic signals to extract and deliver in real time actionable information about a patient's physiologic state, and thus support effective and timely interventions. The Phase 2 effort will deploy and integrate the system into the clinical workflow at Boston Children's Hospital, Children's National Medical Center in Washington D.C., The Hospital for Sick Children (Toronto), and St. Louis Children's Hospital, and evaluate its impact on process of care and patient outcomes. In addition, Etiometry will collaborate with Children's Hospital of Philadelphia (CHOP) Center for Simulation, Advanced Education and Innovation to test the safety, efficacy, usability, and performance characteristics of the system's User Experience (UX) and will refine it to optimize its clinical utility. The ultimate objective of the proposed SBIR effort will be demonstrate that the RMS can significantly affect the quality and cost of care of neonates post-surgery for congenital heart defect.