Wireless Cardiorespiratory Monitor for Neonates

新生儿无线心肺监护仪

• 批准号: 7124186
• 负责人: MICHAEL JOHN SCIARRA
• 金额: $ 34.01万
• 依托单位: PGS MED RESEARCH & ELECTRONIC DESIGN,LLC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-05-24 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7124186
• 关键词: apnea; biomedical device power system; biomedical equipment development; bradycardia; clinical research; computer program /software; computer system design /evaluation; computer system hardware; heart function; heart rate; human subject; newborn human (0-6 weeks); patient monitoring device; portable biomedical equipment; respiratory function

DESCRIPTION (provided by applicant): PGS has developed an innovative low cost infant monitoring technology that is completely wireless and requires no intimate patient contact. The PGS monitor combines a state-of-the-art FDA pre-market approved wireless noninvasive inductive respiration sensor with new photo sensor technology for acquiring heart rate, eliminating wires and electrodes. As medical advances improve, the survival rates of pre-term and low birth weight infants in the U.S. continue to rise along with the need for cost effective monitoring. A phase I feasibility study conducted at Children's National Medical Center, Washington D.C. demonstrated that a viable and stable physiological pulse pressure waveform could reliably be acquired at the umbilicus area of the abdomen on low birth-weight infants in the hospital's NICU. The abdominal area was previously deemed inappropriate for monitoring. We further combined the cardiac sensor with the existing PGS wireless inductive respiration sensor. The clinical data collected in the phase I study demonstrated that the PGS motion artifact rejection performance was superior to the reference pulse oximeter monitor. A phase II study is proposed to refine the PGS monitor design and to validate the event detection and recording features in a variety of care settings. Research activities will focus on 1) technical development, which will employ design guidelines to meet substantial equivalence to existing monitors and 2) clinical study, which is structured to support the clinical requirements for an FDA 510(k) application. These goals will be accomplished through a 9-month hardware and software development phase followed by two clinical studies. The long term goals will be to demonstrate the utility, ease of use and ultimate cost savings benefit to the current monitoring programs utilized in hospitals.

描述（由申请人提供）：PGS 开发了一种创新的低成本婴儿监护技术，该技术完全无线且无需与患者亲密接触。 PGS 监测器将最先进的 FDA 上市前批准的无线无创感应呼吸传感器与新的光电传感器技术相结合，用于获取心率，无需电线和电极。随着医学进步的进步，美国早产儿和低出生体重儿的存活率持续上升，同时需要进行具有成本效益的监测。 在华盛顿特区国家儿童医疗中心进行的一期可行性研究表明，可以在该医院新生儿重症监护病房的低出生体重婴儿的腹部脐区可靠地获取可行且稳定的生理脉压波形。腹部区域以前被认为不适合监测。我们进一步将心脏传感器与现有的 PGS 无线感应呼吸传感器结合起来。 I 期研究收集的临床数据表明，PGS 运动伪影抑制性能优于参考脉搏血氧监测仪。 建议进行 II 期研究，以完善 PGS 监测器设计并验证各种护理环境中的事件检测和记录功能。研究活动将侧重于 1) 技术开发，其中将采用设计指南来满足与现有监测仪的基本等效性；2) 临床研究，旨在支持 FDA 510(k) 申请的临床要求。这些目标将通过为期 9 个月的硬件和软件开发阶段以及随后的两项临床研究来实现。长期目标是展示医院当前使用的监测计划的实用性、易用性和最终节省成本的好处。