Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Ottawa Hospital Research Institute

Status and phase: Completed; Phase 3

Conditions: Cardiac Arrest

Treatments: Procedure: Fixed lower-energy defibrillation; Procedure: Escalating higher-energy defibrillation

Study type: Interventional

Funder types: Other

Identifiers

NCT00212992

2001266-01H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 221 patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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221 participants in 2 patient groups

Fixed lower-energy

Active Comparator group

Description:

Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks

Treatment:

Procedure: Fixed lower-energy defibrillation

Escalating higher-Energy

Active Comparator group

Description:

Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks

Treatment:

Procedure: Escalating higher-energy defibrillation