Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3).
Couper, Keith Ji, Chen Lall, Ranjit Deakin, Charles D Fothergill, Rachael Long, John Mason, James Michelet, Felix Nolan, Jerry P Nwankwo, Henry
Couper, Keith
Ji, Chen
Lall, Ranjit
Deakin, Charles D
Fothergill, Rachael
Long, John
Mason, James
Michelet, Felix
Nolan, Jerry P
Nwankwo, Henry
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2023-12-30
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Abstract
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 registration: ISRCTN14223494, registered 16/08/2021, prospectively registered.
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Couper K, Ji C, Lall R, Deakin CD, Fothergill R, Long J, Mason J, Michelet F, Nolan JP, Nwankwo H, Quinn T, Slowther AM, Smyth MA, Walker A, Chowdhury L, Norman C, Sprauve L, Starr K, Wood S, Bell S, Bradley G, Brown M, Brown S, Charlton K, Coppola A, Evans C, Evans C, Foster T, Jackson M, Kearney J, Lang N, Mellett-Smith A, Osborne R, Pocock H, Rees N, Spaight R, Tibbetts B, Whitley GA, Wiles J, Williams J, Wright A, Perkins GD. Route of drug administration in out-of-hospital cardiac arrest: A protocol for a randomised controlled trial (PARAMEDIC-3). Resusc Plus. 2023 Dec 30;17:100544. doi: 10.1016/j.resplu.2023.100544.
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Article