A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: ‘PrePACE’

摘要: Summary Objective To evaluate the feasibility of a prehospital randomized controlled trial comparing transcutaneous pacing (TCP) with dopamine for unstable bradycardia. Methods Unstable bradycardic patients who failed to respond fluid bolus and up 3 mg atropine were enrolled. The intervention was or TCP crossover if failed. primary outcome survival discharge 30 days. Randomization compliance, safety, follow-up rates, outcome, sample size requirements assessed. Results Of 383 bradycardia, 151 (39%) eligible enrolment 82 (55%) correctly Fifty-five (36%) could not be enrolled practical reasons; 3 had advance directives, 32 met inclusion criteria on arrival at hospital in 20 cases, paramedics chose enroll based circumstances case. remaining 13 missed cases; 8 missing randomization envelopes 5, paramedic forgot. compliance 95% (78/82). Forty-two (51%) seven these crossed over dopamine. Two cases but did receive intervention; either due lack time loss IV access. Three adverse events occurred each group. Survival days 70% (28/40) 69% (29/42) groups, respectively 100% follow up. detect 10% relative difference between treatment arms, 690 per group would required. Conclusions It is feasible conduct bradycardia definitive require multi-centre study.