Novel Pediatric Endotracheal Tube Securement System

新型儿科气管插管固定系统

• 批准号: 10656945
• 负责人: Nick Rydberg
• 金额: $ 74.82万
• 依托单位: MINNESOTA HEALTHSOLUTIONS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10656945
• 关键词: 3D Print; Adhesives; Adolescent; Adult; Adverse event; Age; Anatomy; Biomedical Engineering; Breathing; Cardiopulmonary Resuscitation; Cardiovascular system; Cessation of life; Child; Childhood; Clinical Research; Collaborations; Colorado; Complication; Devices; Effectiveness; Elements; Engineering; Event; Excision; FDA approved; Face; Failure; Feedback; Focus Groups; Health Care Costs; Healthcare; Hospital Costs; Hospitalized Child; Human; Hypercapnia; Hypoxia; Incidence; Infant; Intensive Care; Intratracheal Intubation; Intubation; Length of Stay; Life; Los Angeles; Manikins; Mechanical ventilation; Mechanics; Medical; Methods; Minnesota; Modality; Modeling; Morbidity - disease rate; Neonatal; Neonatal Intensive Care Units; Nurses; Pathologic Processes; Patients; Pediatric Hospitals; Pediatric Intensive Care Units; Performance; Phase; Phase II Clinical Trials; Physician Executives; Physicians; Physiological; Process; Production; Public Health; Randomized Controlled Trials; Recording of previous events; Research; Resources; Safety; Secure; Security; Specialist; Structure; System; Testing; Time; Trauma; Tube; United States; Ventilator; cost; design; endotracheal; experience; hemodynamics; high risk; improved; improved outcome; innovation; intraventricular hemorrhage; multidisciplinary; neonate; novel; pediatric patients; premature; preterm newborn; prototype; research and development; respiratory; rib bone structure; sample fixation; usability; ventilation; ventilator-associated pneumonia

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.

项目摘要/摘要 明尼苏达州HealthSolutions Corporation and Children's Hospital los Angeles提出开发一本小说的提议 小儿/新生儿气管管安全系统，目的是减少计划外的拔管和 相关并发症率。通过气管导管的机械通气是小儿常规的 新生儿重症监护病房，有助于提高生存率和发病率的降低。然而， 不幸的是，计划外拔管很常见，并且与血液动力学不稳定性，缺氧，缺氧有关 Hypercarbia，气道创伤，呼吸机相关的肺炎，脑室内出血和死亡。 新生儿，婴儿和儿童在气管管安全和小儿面临着独特的挑战 由于解剖学和生理因素，患者面临外拔管的风险特别高。那里 对改进的设备或方法可以安全地维护儿科气管管的方法非常热情。 拟议的项目探索了具有几个创新功能的新型安全系统。目的 这个提出的快速轨道项目是开发和评估一种新生儿/儿科安全系统 利用一种新颖的互锁稳定概念，用于FDA清除的成年气管管 安全系统。在建立成人系统的同时，创新的关键要素是儿科独有的 系统包括可调节的稳定器设计，其中连锁安全机构直接锁定 在任何FDA批准的ET管上 易于使用的锁定系统。创新的稳定剂已整合到舒适的，非皮肤的保留率中 专门设计用于适合儿科患者的结构，包括术前新生儿。几个最初的小儿 原型经历了25多种呼吸治疗师，新生儿学家的广泛反馈， 以及重症监护医师和护士。这导致了三种安全设备的成熟设计 跨越从早产新生儿到儿童的范围。第一阶段的目的是确定设计和 制造三个不同尺寸的小儿原型，并评估它们：1）反馈以告知设计， 焦点组的工作流程和可用性改进以及2）在基准模型中抵抗拉动事件的能力。 第二阶段的目的是将原型设计推向成品生产产品，行为 性能台式测试以证明安全性和效率，并在II期中评估了制造单元 随机对照试验。