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

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是开发一种能够有效可靠地固定新生儿重症监护病房中婴儿气管插管的器械。 气管内导管是放置在患者体内的气道，以帮助他们呼吸，但NICU中的婴儿经历了高比例的意外移位和早期移除。这些危险事件主要归因于气管内导管对患者的不良和无效固定。气管插管固定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。这在资源较低的环境中尤其紧迫，这些环境可能具有有限的新生儿复苏经验的工作人员。该项目将开发一个新的系统来支持这些患者。该小型企业创新研究（SBIR）第一阶段项目能够实现先进的患者安全性，以最大限度地降低计划外拔管的风险。由于新生儿的解剖结构脆弱且较小，因此气管插管固定在新生儿中存在独特的挑战。研究目标包括开发一种定制的粘合剂，在孵化器环境中保持功能，并在不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;该奖项反映了NSF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进行评估，被认为值得支持的搜索.

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.