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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：
Nick Rydberg
金额：
$ 93.96万
依托单位：
MINNESOTA HEALTHSOLUTIONS CORPORATION
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

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

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