Elsevier

Resuscitation

Volume 76, Issue 3, March 2008, Pages 341-349
Resuscitation

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

https://doi.org/10.1016/j.resuscitation.2007.08.008Get rights and content

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 to a fluid bolus and up to 3 mg 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 enrolment 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.

Keywords

Emergency Medical Services
Resuscitation
Transcutaneous pacing
Unstable bradycardia
Randomized controlled trial
Exception from informed consent

Cited by (0)

A Spanish translated version of the summary of this article appears as Appendix in the final online version at 10.1016/j.resuscitation.2007.08.008.

☆☆

Presented at the National Association of EMS Physicians Annual Meeting 2005, Naples, FL, 13–15 January 2005 and at the Society for Academic Emergency Medicine (SAEM), Orlando, FL, 19 May 2004.

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