A randomized controlled feasibility trial comparing safety and effectiveness of prehospital pacing versus conventional treatment: 'PrePACE'.
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.
Morrison
Laurie J
LJ
Prehospital and Transport Medicine Research Program, Sunnybrook Health Sciences Centre, Toronto, Ont., Canada. laurie.morrison@sunnybrook.ca
Long
Jennifer
J
Vermeulen
Marian
M
Schwartz
Brian
B
Sawadsky
Bruce
B
Frank
Jamie
J
Cameron
Bruce
B
Burgess
Robert
R
Shield
Jennifer
J
Bagley
Paul
P
Mausz
Vivien
V
Brewer
James E
JE
Dorian
Paul
P
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
D000889:Anti-Arrhythmia Agents; D002316:Cardiotonic Agents; D001285:Atropine; D004298:Dopamine