2/2: Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART)

项目摘要 我们提出了新的儿科院前气道复苏试验（Pedi-PART），以确定最佳的护理人员 危重或受伤儿童的气道管理策略。临床试验的要求包括 以下内容：a）研究常见的辅助气道技术，B）整合临界条件的范围 需要气道管理，c）足够大的入组研究人群以产生有意义的结果，以及d） 创新方法，以提高试验的可行性和适用性。一个关键的创新将是小说 用于确定相对有效性的贝叶斯自适应序贯平台试验（BASiC-PT）框架 三种气道技术（BVM、ETI、SGA）在三种疾病亚组（心脏骤停、创伤、呼吸道疾病）中的 失败），最大限度地利用可用信息，同时最大限度地减少患者数量。 Pedi-PART的新颖设计克服了传统试验在分析、后勤和财务方面的障碍， 设计不可行。我们的目标是： 具体目标1。提供生物统计学领导和专业知识，协助方案设计，研究实施， 心理和管理，数据收集和管理，研究报告和指标，协助 中期和最后研究分析，以及编制公共使用研究数据集， 执行Pedi-PART研究。 具体目标2。为Pedi-PART研究者提供后勤支持和技术专业知识，并协调 教师通过有效的学习培训、有效的质量监控、沟通和参与学习 人员、研究法规文件的维护和有用研究材料的准备（例如， 操作手册），以加强试验的实施。 Pedi-PART是一项务实的试验，旨在为护理人员的最佳实践提供坚实的证据基础。 小儿气道管理这些结果将确定要使用的理想气道技术， 为这里和地球仪的儿童制定最高水平的院前护理指南。

Project Summary We propose the novel Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) to determine the best paramedic strategies for managing the airway in critically ill or injured children. Requirements of a clinical trial include the following: a) study of common paramedic airway techniques, b) integration of the range of critical conditions requiring airway management, c) an enrolled study population large enough to yield meaningful results, and d) innovative approaches to enhance the feasibility and applicability of the trial. A key innovation will be the novel Bayesian Adaptive Sequential Platform Trial (BASiC-PT) framework used to determine the relative effectiveness of three airway techniques (BVM, ETI, SGA) across three disease subgroups (cardiac arrest, trauma, respiratory failure) for all pediatric age categories, maximizing available information while minimizing the number of patients. The novel design of Pedi-PART overcomes analytic, logistical, and financial barriers that make a traditional trial design infeasible. Our aims are: Specific Aim 1. To provide biostatistical leadership and expertise, assistance in protocol design, study imple- mentation and management, data collection and management, study reporting and metrics, assistance in interim and final study analyses, and production of public use research datasets in the establishment and execution of the Pedi-PART study. Specific Aim 2. To provide logistical support and technical expertise for Pedi-PART investigators and coordina- tors, through effective study training, efficient quality monitoring, communication and engagement of study personnel, maintenance of study regulatory documents, and preparation of useful study materials (e.g., manual of operations) to enhance the implementation of the trial. Pedi-PART is a pragmatic trial designed to provide a solid evidence base for best practice in paramedic pediatric airway management. These results will identify the ideal airway techniques to be used, enabling the generation of guidelines for the highest level of prehospital care for children here and across the globe.