Neonatal Intensive Care Unit Telemetry System

新生儿重症监护室遥测系统

• 批准号: 7121602
• 负责人: JOSEPH P GIUFFRIDA
• 金额: $ 36.09万
• 依托单位: CLEVELAND MEDICAL DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7121602
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; clinical biomedical equipment; clinical research; clinical trials; computer program /software; electroencephalography; electromagnetic radiation; electromyography; electrooculography; evaluation /testing; human subject; intensive care; magnetic field; miniature biomedical equipment; newborn human (0-6 weeks); oximetry; patient care management; patient monitoring device; pediatrics; portable biomedical equipment; telemetry; video recording system

DESCRIPTION (provided by applicant): The objective is to develop a miniature, wireless, multi-channel, neonatal intensive care unit (NICU) & monitoring system that provides physiological and behavioral parameters. The system utilizes a small physiological monitor and isolette mounted camera. The NICU is an extremely challenging environment since patients are small, medically fragile, and surrounded by bulky equipment. Current bedside devices are large and cumbersome, which impede nursing care and inhibit clinical traffic. Continuous physiologic monitoring can provide critical data to guide diagnosis and treatment. An unobtrusive monitoring system that can be placed directly into the isolette would allow continuous monitoring while minimizing patient hazards and inconvenience. The final commercial system will provide a small, lightweight wireless system for unobtrusive NICU monitoring. Specifically during the continuing Phase II effort, we plan to upgrade the radio link, increase external sensors options, minimize cost, and ensure the system meets medical equipment quality standards. Software upgrades will improve user friendliness, integrate new tools to compare studies, and provide customizable reporting features. New algorithms will be integrated to improve utility and research flexibility. Significant verification and validation testing will ensure that all applicable standards are met. Finally a large clinical trial will be completed with neonatal subjects to ensure clinical efficacy.

描述(申请人提供)：目标是开发一种微型，无线，多通道，新生儿重症监护病房(NICU)和监测系统，提供生理和行为参数。该系统使用一个小型生理监护仪和独立安装的摄像头。NICU是一个极具挑战性的环境，因为病人很小，医疗上很脆弱，周围都是笨重的设备。目前的床边设备又大又笨重，这阻碍了护理，阻碍了临床交通。持续的生理监测可以为指导诊断和治疗提供关键数据。一个不显眼的监测系统，可以直接放入隔离板中，将允许连续监测，同时将患者的危险和不便降至最低。最终的商业系统将提供一个小型、轻量级的无线系统，用于非侵入性的NICU监测。具体地说，在持续的第二阶段工作中，我们计划升级无线电链路，增加外部传感器选项，最大限度地降低成本，并确保系统符合医疗设备质量标准。软件升级将改善用户友好性，集成用于比较研究的新工具，并提供可定制的报告功能。将整合新的算法，以提高实用性和研究灵活性。重要的验证和确认测试将确保符合所有适用标准。最后，将完成一项针对新生儿受试者的大型临床试验，以确保临床疗效。