title: A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: 'PrePACE'.
abstract: 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 to a fluid bolus and up to 3mg atropine were enrolled. The intervention was dopamine or TCP with crossover to dopamine if TCP failed. The primary outcome was survival to discharge or 30 days. Randomization compliance, safety, follow-up rates, primary outcome, and sample size requirements were assessed.
  
  
  RESULTS
  Of 383 patients with unstable bradycardia, 151 (39%) failed to respond to atropine or fluid and were eligible for enrollment and 82 (55%) were correctly enrolled. Fifty-five (36%) of eligible patients could not be enrolled for practical reasons; 3 had advance directives, 32 met inclusion criteria on arrival at hospital and in 20 cases, paramedics chose not to enroll based on the circumstances of the case. The remaining 13 were missed cases; 8 were missing randomization envelopes and in 5, the paramedic forgot. Randomization compliance was 95% (78/82). Forty-two (51%) patients were randomized to TCP and seven of these crossed over to dopamine. Two cases were randomized but did not receive the intervention; either due to lack of time or loss of IV access. Three adverse events occurred in each group. Survival to discharge or 30 days in hospital was 70% (28/40) and 69% (29/42) in the dopamine and TCP groups, respectively with 100% follow up. To detect a 10% relative difference in 30 days survival between treatment arms, a sample size of 690 per group would be required.
  
  
  CONCLUSIONS
  It is feasible to conduct a prehospital randomized controlled trial of TCP for unstable bradycardia and a definitive trial would require a multi-centre study.
authors.affiliation: Prehospital and Transport Medicine Research Program, Sunnybrook Health Sciences Centre, Toronto, Ont., Canada. laurie.morrison@sunnybrook.ca
authors.forename: Laurie J
authors.initials: LJ
authors.lastname: Morrison
authors.forename: Jennifer
authors.initials: J
authors.lastname: Long
authors.forename: Marian
authors.initials: M
authors.lastname: Vermeulen
authors.forename: Brian
authors.initials: B
authors.lastname: Schwartz
authors.forename: Bruce
authors.initials: B
authors.lastname: Sawadsky
authors.forename: Jamie
authors.initials: J
authors.lastname: Frank
authors.forename: Bruce
authors.initials: B
authors.lastname: Cameron
authors.forename: Robert
authors.initials: R
authors.lastname: Burgess
authors.forename: Jennifer
authors.initials: J
authors.lastname: Shield
authors.forename: Paul
authors.initials: P
authors.lastname: Bagley
authors.forename: Vivien
authors.initials: V
authors.lastname: Mausz
authors.forename: James E
authors.initials: JE
authors.lastname: Brewer
authors.forename: Paul
authors.initials: P
authors.lastname: Dorian
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001285:Atropine / Q000627:therapeutic use; D001919:Bradycardia / Q000401:mortality / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D002316:Cardiotonic Agents / Q000627:therapeutic use; D018592:Cross-Over Studies; D004298:Dopamine / Q000627:therapeutic use; D004632:Emergency Medical Services; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D002316:Cardiotonic Agents; D001285:Atropine; D004298:Dopamine