Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3)

Aims: The PARAMEDIC -3 trial evaluates the clinical and cost-effectiveness of an intraosseous first strategy, compared with an intravenous first strategy, for drug administration in adults who have sustained an out -of -hospital cardiac arrest. Methods: PARAMEDIC -3 is a pragmatic, allocation concealed, open -label, multi -centre, superiority randomised controlled trial. It will recruit 15,000 patients across English and Welsh ambulance services. Adults who have sustained an out -of -hospital cardiac arrest are individually randomised to an intraosseous access first strategy or intravenous access first strategy in a 1:1 ratio through an opaque, sealed envelope system. The randomised allocation determines the route used for the first two attempts at vascular access. Participants are initially enrolled under a deferred consent model. The primary clinical -effectiveness outcome is survival at 30 -days. Secondary outcomes include return of spontaneous circulation, neurological functional outcome, and health -related quality of life. Participants are followed -up to six -months following cardiac arrest. The primary health economic outcome is incremental cost per quality -adjusted life year gained. Conclusion: The PARAMEDIC -3 trial will provide key information on the clinical and cost-effectiveness of drug route in out -of -hospital cardiac arrest. Trial