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

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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.