Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

This study will compare the effect of constant low-level energy [150 joules] to an escalating energy [200-300-360 joules] regimen of biphasic waveform defibrillation on multiple patient outcomes.

This pilot, which will enroll 200 subjects, will allow a reasonable estimate of effect size and this will, in turn, allow for the accurate design and planning of a definitive randomized controlled trial. The following outcomes will be evaluated:

1. Important Clinical Outcomes:

   • Successful conversion,
   • Resuscitation to one hour,
   • Survival to hospital discharge,
   • Neurological function, and
   • Quality of life.

2. Process Outcomes:

   • Number of shocks required,
   • Recurrences of VF, and
   • Responsiveness to varying periods of pulselessness.

3. Adverse Outcomes:

   • Myocardial damage.

Inclusion Criteria:

• Witnessed cardiac arrest out-of-hospital requiring defibrillation and given by first responder using an automated external defibrillator

Exclusion Criteria:

• Terminal illness or do-not-resuscitate (DNR) status
• No cardiopulmonary resuscitation (CPR) x 10 minutes
• Acute trauma
• Exsanguination
• Cardiac arrest experienced while in hospital