Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

April 24, 2025 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fixed lower-energy
Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks
Procedure: Fixed lower-energy defibrillation
Every shock administered at 150 J
Active Comparator: Escalating higher-Energy
Out-of-hospital cardiac arrest patients undergoing defibrillation received an escalating higher-energy regimen beginning with 200 J, proceeding to 300 J for the second shock and 360 J for all remaining shocks
Procedure: Escalating higher-energy defibrillation
First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful Conversion to an Organized Heart Rhythm
Time Frame: Termination of defibrillation
Termination of defibrillation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to Hospital Discharge
Time Frame: 30 days
30 days
Resuscitation for Survival to One Hour
Time Frame: One hour from termination of defibrillation
One hour from termination of defibrillation
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.
30 days
Return of Spontaneous Circulation
Time Frame: Termination of defibrillation
Termination of defibrillation
Survival to 24 Hours
Time Frame: 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Principal Investigator: Ian Stiell, MD, OHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2001

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimated)

September 21, 2005

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001266-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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