Novel Pediatric Endotracheal Tube Securement System

新型儿科气管插管固定系统

• 批准号: 10670972
• 负责人: Nick Rydberg
• 金额: $ 93.96万
• 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/10670972
• 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; Marketing; 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; Trauma; Tube; United States; Ventilator; commercialization; cost; design; endotracheal; experience; hemodynamics; high risk; improved; improved outcome; innovation; intraventricular hemorrhage; irritation; manufacture; 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.

项目概要/摘要 明尼苏达州健康解决方案公司和洛杉矶儿童医院提议开发一种新型药物 儿科/新生儿气管插管固定系统，旨在减少意外拔管和 相关并发症发生率通过气管插管进行机械通气是儿科和儿科患者的常规治疗。 新生儿重症监护病房，有助于提高生存率并降低发病率。 不幸的是，意外拔管很常见，并且与血流动力学不稳定、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、婴儿和儿童在气管插管固定和儿科方面面临着独特的挑战 由于解剖和生理因素，患者意外拔管的风险特别高。 人们对用于安全维护儿科气管插管的改进装置或方法怀有极大的热情。 拟议项目探索了一种具有多项创新功能的新型安全系统。 该拟议的快速通道项目旨在开发和评估新生儿/儿科安全系统， 利用一种新颖的联锁稳定器概念，该概念用于 FDA 成人气管插管 在构建成人系统的同时，创新的关键要素是儿科独有的。 系统包括可调节稳定器设计，其中联锁安全机制直接锁定 安装在任何 FDA 批准的 ET 管上，并可调节地安装到稳定器上相应的肋状接收器中，并带有 易于使用的锁定系统集成了舒适、无皮肤刺激的固定装置。 专门为儿科患者（包括早产儿）设计的结构。 原型得到了超过 25 名呼吸治疗师、新生儿学家的广泛、反复的反馈， 这导致了三种安全设备的成熟设计。 第一阶段的目标是最终确定设计并涵盖从早产儿到儿童的范围。 制造 3 个不同尺寸的儿科原型并评估它们：1) 为设计提供信息的反馈， 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动事件的能力。 第二阶段的目标是将原型设计推进到成品生产，进行 性能台架测试，以证明安全性和有效性，并评估第二阶段的制造单元 随机对照试验。