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Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

This study has been completed.
Sponsor:
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00212992
First received: September 13, 2005
Last updated: September 23, 2006
Last verified: September 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
 Procedure: fixed versus escalating biphasic defibrillation
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial to Compare Fixed Versus Escalating Energy Regimens for Biphasic Waveform Defibrillation

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Successful conversion to an organized heart rhythm

Secondary Outcome Measures:
  • Survival to hospital discharge
  • Resuscitation for survival to one hour
  • Neurologic function
  • Removal of ventricular fibrillation (VF) in 5 seconds
  • Return of spontaneous circulation
  • Survival to 24 hours

Estimated Enrollment: 200
Study Start Date: March 2001
Estimated Study Completion Date: July 2006
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.
  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212992

Locations
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Ian Stiell, MD OHRI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00212992     History of Changes
Other Study ID Numbers: 2001266-01H
Study First Received: September 13, 2005
Last Updated: September 23, 2006
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
defibrillation
ventricular fibrillation
heart arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013