Every year, 30,000 people in the UK suffer a cardiac arrest outside of a hospital, and paramedics must decide the fastest way to inject life-saving drugs into their veins. The problem is that the standard method—finding a vein in the arm for an intravenous (IV) line—often fails in these chaotic, time-critical moments, delaying treatment. This trial will test a different approach: drilling a small needle directly into the shinbone (intraosseous, or IO) as the first attempt, rather than only as a backup after two failed IV tries. The researchers will randomise 15,000 patients across NHS ambulance services to either the IO-first strategy or current practice, measuring survival at 30 days and neurological recovery. If the IO-first strategy improves survival by just 1%, it would save an additional 150 lives each year in the NHS. The results will also include a full cost-effectiveness analysis, determining whether the change is worth the investment for the health service. This is a pragmatic, definitive trial designed to settle a long-standing debate and directly reshape emergency care protocols across the UK and internationally.
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RESEARCH QUESTION: Population: Adults with out-of-hospital cardiac arrest Intervention: Intraosseous (IO) first strategy Comparator: Current NHS treatment (2 attempts at IV access before attempting IO access) Outcomes: Survival, favourable neurological outcome, health-related quality of life and cost effectiveness Study design: Multi-centre, pragmatic, individually randomised, parallel group, trial and economic evaluation Timeline: 48 months. BACKGROUND: 30,000 people sustain an out-of-hospital cardiac arrest each year. Parenteral drugs are an effective treatment and the earlier drugs are given the greater their impact. The best route for administering drugs is currently unknown, resulting in variation in practice and uncertainty about the optimal approach. AIM: To conduct a multi-centre, pragmatic, individually randomised, parallel group, superiority trial and economic evaluation to determine the clinical and cost effectiveness of an intraosseous access first strategy, versus current NHS treatment. The trial will include an internal pilot to confirm feasibility. OBJECTIVES: (1) Conduct an internal pilot study to confirm the feasibility of the large-scale multicentre trial (2) Determine the clinical effectiveness of an IO first strategy for adults with out-of-hospital cardiac arrest upon survival, favourable neurological outcomes and health-related quality of life. (3) Estimate, in an integrated economic evaluation, the cost-effectiveness of an IO first strategy. METHODS: Setting: NHS Ambulance Services across England and Wales. Randomisation: Allocation concealed, randomisation (1:1), stratified by ambulance service. Inclusion criteria: • Adult (age >18) • Out-of-hospital cardiac arrest • Requirement for vascular access to administer cardiac arrest drugs Exclusion criteria: • Known or suspected pregnancy • Already have vascular access Health technologies being assessed: Intraosseous first strategy compared with current NHS treatment (2 attempts at IV access before IO access) Primary outcome: • Survival to 30 days Secondary outcomes: • Any return of spontaneous circulation (ROSC) • Time to ROSC • Survived event (sustained ROSC at hospital handover) • Survival to hospital discharge, 3 and 6 months • Neurological outcome (modified Rankin Scale) at discharge, 3, and 6 months • Health related quality of life (EQ-5D-5L) at 3 and 6 months • Hospital and intensive care length of stay Economic outcomes: • Incremental cost per quality-adjusted life year gained from the perspective of the NHS and personal social services. • Within-trial and life-time model estimates will be generated. Sample size: 15,000 participants (90% power, 5% significance, to detect 1% absolute difference in survival). ANTICIPATED IMPACT AND DISSEMINATION: The study will provide definitive evidence for the most effective vascular access strategy during out-of-hospital cardiac arrest. The findings will define future NHS and international practice. A 1% absolute difference in survival will translate to an additional 150 lives saved each year in the NHS. We will publish lay and professional summaries in written, audible and infographic styles. We will disseminate through public engagement events, peer reviewed publications, podcasts, blogs, conference presentations social media and our membership of key organisations
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