Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy
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.
Procedure: fixed versus escalating biphasic defibrillation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation|
- Successful conversion to an organized heart rhythm
- Survival to hospital discharge
- Resuscitation for survival to one hour
- Neurologic function
- Removal of ventricular fibrillation (VF) in 5 seconds
- Return of spontaneous circulation
- Survival to 24 hours
|Study Start Date:||March 2001|
|Estimated Study Completion Date:||July 2006|
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:
Important Clinical Outcomes:
- Successful conversion,
- Resuscitation to one hour,
- Survival to hospital discharge,
- Neurological function, and
- Quality of life.
- Number of shocks required,
- Recurrences of VF, and
- Responsiveness to varying periods of pulselessness.
- Myocardial damage.