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

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是开发一种有效和可靠地固定新生儿重症监护病房中婴儿的气管内管的设备。气管插管是放置在患者体内帮助他们呼吸的呼吸道，但NICU中的婴儿经历了高比例的计划外脱出和早期拔除。这些危险事件主要归因于患者气管插管固定不良和无效。气管内插管安全的综合解决方案将减少美国每年发生的80,000多例新生儿插管的并发症。这在资源较少的环境中尤其紧迫，因为在新生儿复苏方面经验丰富的工作人员可能有限。该项目将开发一种新的系统来支持这些患者。这一小型企业创新研究(SBIR)第一阶段项目使先进的患者安全措施能够将计划外拔管的风险降至最低。考虑到新生儿的精致和细小的解剖结构，气管内管固定对新生儿来说是一个独特的挑战。研究目标包括开发一种定制粘合剂，该粘合剂在孵化器环境中保持功能，并在欠发达的新生儿面部皮肤上使用；设计、验证和制造设备固定机制；以及与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NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.