Novel Pediatric Endotracheal Tube Securement System

项目摘要/摘要 明尼苏达医疗解决方案公司和洛杉矶儿童医院提议开发一种新的 儿童/新生儿气管插管固定系统，目的是减少非计划拔管和 相关并发症发生率。经气管插管机械通气在儿科和婴幼儿中是常规的 新生儿重症监护病房，有助于提高存活率和降低发病率。然而， 不幸的是，非计划拔管很常见，并与血流动力学不稳定、缺氧、 高碳酸血症、呼吸道损伤、呼吸机相关性肺炎、脑室出血和死亡。 新生儿、婴儿和儿童在气管内插管和儿科手术中面临着独特的挑战 由于解剖和生理因素，患者非计划拔管的风险特别高。那里 对于安全维护儿科气管插管的改进设备或方法存在极大的热情。 拟议的项目探索了一种具有几个创新特征的新型安全系统。的目标是 这个提议的快速通道项目是开发和评估新生儿/儿科安全系统，该系统 利用一种新的联锁稳定器概念，用于FDA批准的成人气管插管 安全系统。在建立成人系统的同时，儿科独特的创新的关键要素 系统包括一个可调节的稳定器设计，联锁固定机构直接锁定 在FDA批准的任何ET管上，并可调整地安装在稳定器上的相应肋形接收器中，具有 易于使用的锁定系统。创新的稳定剂被集成到舒适、不刺激皮肤的固位中 专为包括早产儿在内的儿科患者设计的结构。几个初级儿科医生 原型已经接受了超过25名呼吸治疗师、新生儿病学家、 以及重症监护医生和护士。这导致了三种安全装置的成熟设计，以 范围从早产儿到儿童。第一阶段的目标是最终确定设计和 制造3个不同大小的儿科原型并对其进行评估：1)反馈以告知设计， 重点小组中的工作流程和可用性改进，以及2)在工作台模型中抵抗拉动事件的能力。 第二阶段的目标是将原型设计推进到成品，进行 性能试验台测试，以证明安全性和有效性，并在第二阶段评估已生产的部件 随机对照试验。

Project Summary/Abstract Minnesota HealthSolutions Corporation and Children’s Hospital Los Angeles propose to develop a novel pediatric/neonatal endotracheal tube securement system with the aim of reducing unplanned extubation and associated complication rates. Mechanical ventilation through an endotracheal tube is routine in pediatric and neonatal intensive care units and has contributed to improved survival and reduced morbidity. However, unplanned extubations are unfortunately common, and are associated with hemodynamic instability, hypoxia, hypercarbia, airway trauma, ventilator associated pneumonia, intraventricular hemorrhage, and death. Neonates, infants and children have unique challenges with endotracheal tube securement and pediatric patients are at particularly high risk for unplanned extubation due to anatomic and physiologic factors. There exists great enthusiasm for improved devices or methods for safely maintaining pediatric endotracheal tubes. The proposed project explores a novel securement system with several innovative features. The objective of this proposed fast-track project is to develop and evaluate a neonatal/pediatric securement system that leverages a novel interlocking stabilizer concept which is used in an FDA cleared adult endotracheal tube securement system. While building off the adult system, key elements of innovation unique to the pediatric system include an adjustable stabilizer design where the interlocking securement mechanism is locked directly onto any FDA approved ET tube and adjustably fits into a corresponding ribbed receiver on a stabilizer with an easy-to-use locking system. The innovative stabilizer is integrated into comfortable, non-skin-irritating retention structures specifically designed to fit pediatric patients, including pre-term neonates. Several initial pediatric prototypes have undergone extensive, iterative feedback from over 25 respiratory therapists, neonatologists, and intensive care physicians and nurses. This has resulted in mature designs of three securement devices to span the range from preterm neonates to children. The objective of phase I is to finalize the design and manufacture the 3 different sized pediatric prototypes and evaluate their: 1) feedback to inform design, workflow and usability refinements in focus groups and 2) ability to resist pull events in a bench-top model. The objective of phase II is to advance the prototype design to a finished production product, conduct performance bench testing to demonstrate safety and efficacy, and evaluate manufactured units in a phase II randomized controlled trial.