Prehospital Randomised Assessment of a Mechanical Compression Device in out of Hospital Cardiac Arrest (PARAMEDIC): a pragmatic cluster randomised trial and economic evaluation

Design: Cluster randomised controlled trial. Randomisation units are ambulance and rapid response vehicles. Setting: Pre-hospital care. Target population: Patients suffering out of hospital cardiac arrest where a resuscitation attempt is appropriate. Exclusions are age under 18 years, pregnancy and traumatic cardiac arrest. Health technologies being assessed: Chest compressions given using the LUCAS (Lund University Cardiopulmonary Assistance System) mechanical compression/decompression device versus standard manual compression. Measurement of costs and outcomes: Primary outcome: survival to 30 days post cardiac arrest. Secondary outcomes: 1. survived event (survival to hospital); 2. Survived to hospital discharge; 3. survival to 3 and 12 months; 4. health related quality of life at 3 and 12 months (SF12); 5. neurological outcome at discharge from hospital (Cerebral Performance Category (CPC) score 1-2 v 3-5); 6. neurological outcome at 12 months (Mini Mental State Examination (MMSE)); 7. anxiety and depression at 12 months (Hospital Anxiety and Depression Scale (HADS)); 8. Post Traumatic Stress at 12 months (PTSD civilian checklist (PCL-C)); 9. hospital length of stay; 10. intensive care length of stay. Outcomes up to hospital admission will be reported by the attending paramedic. Survivors will be flagged at NHSCR to ensure that all deaths are notified. Follow-up visits to surviving patients wanting to take part will be carried out by a Research Nurse at 3 and 12 months. Sample size: 418 clusters; 4,344 participants. This is sufficient to detect an increase in survival to hospital discharge from 5% in the manual compression group to 7.5% in the LUCAS group. Expertise. The trial will be co-ordinated by the Warwick Medical School Clinical Trials Unit. The Unit has extensive experience of management of large-scale health care evaluations. The trial staff will include a co-ordinator, data manager, programmer, statistician and health economist, as well as paramedic research fellows who will undertake training and liaison with participating paramedics. The trial will be conducted according the Unit's Standard Operating Procedures, and managed according to the unit's usual practice. The expertise of the applicants covers all relevant areas including emergency medicine, resuscitation, intensive care, health economics, pre-hospital care, trial management and statistics.