Novel Pediatric Endotracheal Tube Securement System

新型儿科气管插管固定系统

基本信息

  • 批准号:
    10670972
  • 负责人:
  • 金额:
    $ 93.96万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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.
项目总结/文摘

项目成果

期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
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Nick Rydberg其他文献

Nick Rydberg的其他文献

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{{ truncateString('Nick Rydberg', 18)}}的其他基金

Novel Pediatric Endotracheal Tube Securement System
新型儿科气管插管固定系统
  • 批准号:
    10656945
  • 财政年份:
    2022
  • 资助金额:
    $ 93.96万
  • 项目类别:
Novel Wiring Catheter for Crossing Complex Chronic Total Occlusions
用于穿越复杂慢性完全闭塞的新型导丝导管
  • 批准号:
    10483058
  • 财政年份:
    2022
  • 资助金额:
    $ 93.96万
  • 项目类别:
Novel Pediatric Endotracheal Tube Securement System
新型儿科气管插管固定系统
  • 批准号:
    10255952
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Improved Delivery System for Drug-Coated Balloon Therapy
改进的药物涂层球囊治疗输送系统
  • 批准号:
    10324442
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Automated Long-Term Oxygen Therapy Control System
自动化长期氧疗控制系统
  • 批准号:
    10758875
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Safety-Enhancing Motor Vehicle Child Safety Seat
增强安全性的机动车儿童安全座椅
  • 批准号:
    10505200
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Safety-Enhancing Motor Vehicle Child Safety Seat
增强安全性的机动车儿童安全座椅
  • 批准号:
    10323470
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Automated Long-Term Oxygen Therapy Control System
自动化长期氧疗控制系统
  • 批准号:
    10324103
  • 财政年份:
    2021
  • 资助金额:
    $ 93.96万
  • 项目类别:
Improved Systems for Respiratory Support
改进的呼吸支持系统
  • 批准号:
    10274746
  • 财政年份:
    2020
  • 资助金额:
    $ 93.96万
  • 项目类别:
Improved Systems for Respiratory Support
改进的呼吸支持系统
  • 批准号:
    10473546
  • 财政年份:
    2020
  • 资助金额:
    $ 93.96万
  • 项目类别:

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