Novel Pediatric Endotracheal Tube Securement System

项目概要/摘要 明尼苏达健康解决方案公司和洛杉矶儿童医院提议开发一种新的 儿科/新生儿气管插管固定系统，旨在减少计划外拔管， 相关并发症发生率。通过气管内导管进行机械通气在儿科是常规的， 新生儿重症监护病房，并有助于提高生存率和降低发病率。然而，在这方面， 不幸的是，无计划的拔管是常见的，并且与血液动力学不稳定，缺氧， 高碳酸血症、气道创伤、呼吸机相关性肺炎、脑室内出血和死亡。 新生儿、婴儿和儿童在气管内导管固定和儿科应用方面面临独特的挑战。 患者由于解剖和生理因素而处于特别高的非计划拔管风险中。那里 对安全维护小儿气管内导管的改进装置或方法存在极大的热情。 拟议的项目探索了一种具有多项创新功能的新型固定系统。的目标 该快速通道项目旨在开发和评估一种新生儿/儿科安全系统， 利用了一种新颖的联锁稳定器概念，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，儿科系统独特的创新关键要素 系统包括可调节稳定器设计，其中互锁固定机构被直接锁定 安装到任何FDA批准的ET管上，并可调节地安装到稳定器上的相应肋状接收器中， 易于使用的锁定系统。创新的稳定剂被集成到舒适，非皮肤刺激性保留 专为儿科患者（包括早产儿）设计的结构。几个最初的儿科 原型已经经历了超过25位呼吸治疗师，呼吸科医生， 重症监护医生和护士。这导致了三种固定装置的成熟设计， 从早产儿到儿童。第一阶段的目标是最后完成设计， 制造3种不同尺寸的儿科原型并评价其：1）反馈以告知设计， 焦点小组中的工作流程和可用性改进，以及2）在台式模型中抵抗拉事件的能力。 第二阶段的目标是将原型设计推进到最终生产产品， 性能台架测试，以证明安全性和有效性，并在第二阶段评估生产的装置 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.