SBIR Phase I: A Medical Device to Secure Endotracheal Tubes and Reduce Unplanned Extubations for Neonates in Intensive Care

SBIR 第一阶段：用于保护重症监护新生儿气管插管并减少意外拔管的医疗设备

• 批准号: 2036668
• 负责人: Eric Chehab
• 金额: $ 25.6万
• 依托单位: Novonate Inc
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-15 至 2022-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2036668&HistoricalAwards=false
• 关键词: SBIR; Phase; Medical; Device; Secure

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to develop a device that effectively and reliably secures endotracheal tubes for babies in the neonatal intensive care unit. Endotracheal tubes are airways placed in patients to help them breathe, but babies in the NICU experience high rates of unplanned dislodgement and early removal. These dangerous events are primarily attributed to poor and ineffective securement of the endotracheal tube to the patient. An integrated solution to endotracheal tube securement would reduce complications for the 80,000+ neonatal intubations that occur every year in the United States. This is especially urgent in lower-resourced settings that may have limited staff that are experienced in neonatal resuscitation. This project will develop a new system to support these patients. This Small Business Innovation Research (SBIR) Phase I project enables advanced patient securement to minimize the risk of unplanned extubations. Endotracheal tube securement presents unique challenges in neonates, given their delicate and small anatomy. The research objectives include developing a custom adhesive that maintains functionality in incubator environments and in use on underdeveloped neonatal facial skin; designing, validating, and manufacturing device securement mechanisms; and conducting bench testing and simulated use testing with clinicians.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是开发一种设备，有效和可靠地保护新生儿重症监护病房的婴儿气管内管。气管内管是放置在病人体内帮助他们呼吸的气道，但新生儿重症监护室的婴儿出现计划外移位和早期拔除的几率很高。这些危险事件主要是由于气管内管对患者的不良和无效的保护。气管插管固定的综合解决方案将减少美国每年发生的8万多例新生儿插管的并发症。在资源匮乏的环境中，这一点尤其紧迫，因为在新生儿复苏方面经验丰富的工作人员可能有限。这个项目将开发一个新的系统来支持这些病人。这项小型企业创新研究（SBIR）一期项目使先进的患者安全措施能够最大限度地减少计划外拔管的风险。气管插管的安全提出了独特的挑战，在新生儿，由于他们的精致和小解剖。研究目标包括开发一种定制粘合剂，在培养箱环境中保持功能，并用于未发育的新生儿面部皮肤；设计、验证和制造设备安全机制；和临床医生一起进行台架测试和模拟使用测试。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。