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Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00212992
First received: September 13, 2005
Last updated: January 23, 2017
Last verified: January 2017
  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
Intervention Model: Single Group Assignment
Masking: Double
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:


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
Actual Study Start Date: March 2001
Study Completion Date: July 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00212992     History of Changes
Other Study ID Numbers: 2001266-01H
Study First Received: September 13, 2005
Last Updated: January 23, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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 September 21, 2017