1/2 – Pediatric Prehospital Airway Resuscitation Trial

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PROJECT SUMMARY We aim to answer the signature question of paramedic care; “What is the best way to manage the prehospital airway in critically ill children?” Cardiac arrest, respiratory failure, and major trauma are devastating critical conditions in children. Resuscitation from critical illness requires skillful airway management to optimize delivery of oxygen to the lungs, preventing irreparable damage to the brain and heart. As the first to provide critical care, prehospital paramedics often perform life-saving airway management on critically ill children. The most common prehospital airway management techniques (bag-valve-mask ventilation (BVM), endotracheal intubation (ETI), and supraglottic airway insertion (SGA) have important trade- offs between risks and benefits; the best approach is unknown. We propose the novel Pediatric Prehospital Airway Resuscitation Trial (Pedi-PART) to determine the best strategies for prehospital airway management in critically ill children. Pedi-PART will immediately influence paramedic practices and have a lasting impact upon the health of children internationally. We will determine the relative effectiveness of three airway strategies ([BVM-only], [BVM+ETI], [BVM+SGA]), accounting for variations across disease (cardiac arrest, trauma, respiratory failure) and age categories, and we will apply adaptive techniques to minimize the required number of patients. Our aims are: AIM I: Prepare the Pediatric Emergency Care Applied Research Network (PECARN) to execute the innovative Pedi-PART trial. PECARN is the nation’s premier pediatric emergencies research network. We have assembled an alliance of over 60 EMS agencies from 10 communities associated with PECARN and their ongoing Pediatric Dose Optimization for Seizures in EMS trial (PediDOSE - U01-NS114042). AIM II: Compare the effectiveness of prehospital BVM, SGA, and ETI airway management strategies upon pediatric cardiac arrest, major trauma, and respiratory failure outcomes. We will execute the trial in two sequential stages. Stage I: Determine if [BVM-only] or [BVM followed by SGA] results in better ICU-free survival in critically ill children with cardiac arrest, major trauma, or respiratory failure. Stage II: Determine if [winner of Stage I] or [BVM followed by ETI] results in better ICU-free survival. AIM III: Compare the safety of prehospital BVM, SGA, and ETI airway management strategies in pediatric cardiac arrest, major trauma, and respiratory failure. In Stage I, we will determine if [BVM+SGA] results in fewer prehospital and hospital adverse events compared with [BVM-only] in critically ill children with cardiac arrest, major trauma, or respiratory failure. In Stage II, we will determine if the winner of Stage I results in fewer adverse events compared with [BVM+ETI].