Phase 3
N=221
Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy
Cardiac Arrest
Bottom Line
View on ClinicalTrials.gov: NCT00212992 ↗Enrolled (actual)
221
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Successful Conversion to an Organized Heart Rhythm — 28; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fixed lower-energy defibrillation (Procedure); Escalating higher-energy defibrillation (Procedure)
- Age
- Pediatric, Adult, Older Adult · 8+ yrs
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Sep 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Conversion to an Organized Heart Rhythm |
28; 39 | — |
| SECONDARY Survival to Hospital Discharge |
19; 17 | — |
| SECONDARY Resuscitation for Survival to One Hour |
54; 44 | — |
| SECONDARY Neurologic Function |
2; 2 | — |
| SECONDARY Return of Spontaneous Circulation |
58; 52 | — |
| SECONDARY Survival to 24 Hours |
37; 38 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00212992). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.