Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Phase 3

Completed

• Conditions: Cardiac Arrest

• Registration Number: NCT00212992
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Study Completion: 2006-07
• Results First Submitted: 2025-03-21
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Results First Posted: 2025-04-25
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successful Conversion to an Organized Heart Rhythm	Termination of defibrillation

Secondary Outcome Measures

Name	Time	Method
Survival to Hospital Discharge	30 days
Resuscitation for Survival to One Hour	One hour from termination of defibrillation
Neurologic Function	30 days	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.
Return of Spontaneous Circulation	Termination of defibrillation
Survival to 24 Hours	24 hours

Trial Locations

Locations (1)

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada