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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
221
Every shock administered at 150 J
First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J
Ottawa Hospital
Ottawa, Ontario, Canada
Successful Conversion to an Organized Heart Rhythm
Time frame: Termination of defibrillation
Survival to Hospital Discharge
Time frame: 30 days
Resuscitation for Survival to One Hour
Time frame: One hour from termination of defibrillation
Neurologic Function
The Cerebral Performance Category Score (CPC) is a five-point scale used to assess neurological outcomes after cardiac arrest. The best score, 1, indicates good cerebral performance. The worst score, 5, represents brain death.
Time frame: 30 days
Return of Spontaneous Circulation
Time frame: Termination of defibrillation
Survival to 24 Hours
Time frame: 24 hours
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