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Completed

NCT Number: NCT00212992

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.

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Key information

Conditions

Cardiac Arrest Arrhythmias, Cardiac Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Fibrillation

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

About this study

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.
  • Process Outcomes:
  • Number of shocks required,
  • Recurrences of VF, and
  • Responsiveness to varying periods of pulselessness.
  • Adverse Outcomes:
  • Myocardial damage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed lower-energy defibrillation

Procedure

Every shock administered at 150 J

Escalating higher-energy defibrillation

Procedure

First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J

Primary outcomes

  1. Successful Conversion to an Organized Heart Rhythm

    Time frame: Termination of defibrillation

Secondary outcomes

  1. Survival to Hospital Discharge

    Time frame: 30 days

  2. Resuscitation for Survival to One Hour

    Time frame: One hour from termination of defibrillation

  3. Neurologic Function

    Time frame: 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.

  4. Return of Spontaneous Circulation

    Time frame: Termination of defibrillation

  5. Survival to 24 Hours

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

Important dates

Study start
2001
Primary completion
2005
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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