Development of a novel neonatal resuscitation monitor to ensure safe and effective provision of breathing support to newborn infants

开发新型新生儿复苏监测仪，确保为新生儿提供安全有效的呼吸支持

• 批准号: 10054756
• 金额: $ 43.46万
• 依托单位: EUROPLAZ TECHNOLOGIES LTD
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10054756
• 关键词: Development; novel; neonatal; resuscitation; monitor

UK medical device SME, Europlaz is ISO13485 and has a core project team of Frede Jensen (Neonatal Medical Device Specialist), Ian Goodacre (Engineering Manager), Katharine O'Keeffe (Business Sponsor and Project Manager).Delivery room resuscitation is needed for 10% of newborns. Resuscitation of neonates is stressful and highly pressured, but clinicians do not have the equipment to enable them to accurately evaluate the baby's cardio-respiratory system and act accordingly. Three-quarters of newborn resuscitations are considered unsafe or below the accepted standard (Vaidya,2021 ). Total cost of maternity care claims are £4.2bn and brain damage during birth accounts for 39%, or £1.6bn. The lack of reliable, objective data hinders the evaluation of errors and limits opportunities for learning/improvement.Europlaz's solution is an intuitive, multiple-parameter, respiratory monitor to display tidal volume, C02 elimination, Sp02, dual (R/L) oxygenation and mask leak for even the smallest patients. The device enhances NICU capability and transfers skills to the under-served, low-tech delivery room.Real-time data is displayed as a straightforward bar graph, and export enables recording the resuscitation event for accountability and learning/improvement. Europlaz is bringing ICU technology (tidal volume/CO2) into the maternity ward.The Europlaz device will improve resuscitation efficiency and prevent volume induced lung and CO2 induced brain injuries. It will reduce the escalations of 2.2% of babies into high-intensive care and could save the NHS £15M in neonatal intensive care. The innovation compensates for staffing shortages and skills deficits.The project will increase R&D activity by 50% and will create 20+ jobs for a medical device manufacturing company producing life saving products here in the UK.

英国医疗器械SME，Europlaz是ISO 13485，拥有核心项目团队弗雷德詹森（新生儿医疗器械专家），Ian Goodacre（工程经理），Katharine O 'Keeffe（业务赞助商和项目经理）。10%的新生儿需要产房复苏。新生儿的复苏是紧张和高压的，但临床医生没有设备，使他们能够准确地评估婴儿的心肺系统，并采取相应的行动。四分之三的新生儿复苏被认为是不安全的或低于公认的标准（Vaidya，2021）。产妇护理索赔的总成本为42亿英镑，分娩期间的脑损伤占39%，即16亿英镑。缺乏可靠、客观的数据阻碍了对错误的评估，并限制了学习/改进的机会。Europlaz的解决方案是一种直观、多参数的呼吸监测仪，可以显示潮气量、CO2消除、Sp 02、双（R/L）氧合和面罩泄漏，即使是最小的患者。该设备增强了新生儿重症监护室的能力，并将技能转移到服务不足、技术含量低的产房。实时数据显示为简单的条形图，导出功能可以记录复苏事件，以便进行问责和学习/改进。Europlaz将ICU技术（潮气量/CO2）引入产科病房。Europlaz设备将提高复苏效率，防止容量诱导的肺损伤和CO2诱导的脑损伤。它将减少2.2%的婴儿进入高度重症监护的升级，并可以为NHS节省1500万英镑的新生儿重症监护费用。该创新弥补了人员短缺和技能不足。该项目将使研发活动增加50%，并将为英国一家生产救生产品的医疗器械制造公司创造20多个就业机会。