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Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Primary Purpose

Cardiac Arrest

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

fixed versus escalating biphasic defibrillation

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring defibrillation, ventricular fibrillation, heart arrest

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ottawa Hospital

Outcomes

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

Full Information

NCT ID

NCT00212992

First Posted

September 13, 2005

Last Updated

January 23, 2017

Sponsor

Ottawa Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00212992

Brief Title

Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2001 (Actual)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

defibrillation, ventricular fibrillation, heart arrest

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

fixed versus escalating biphasic defibrillation

Primary Outcome Measure Information:

Title

Successful conversion to an organized heart rhythm

Secondary Outcome Measure Information:

Title

Survival to hospital discharge

Title

Resuscitation for survival to one hour

Title

Neurologic function

Title

Removal of ventricular fibrillation (VF) in 5 seconds

Title

Return of spontaneous circulation

Title

Survival to 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian Stiell, MD

Organizational Affiliation

OHRI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4E9

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17353443

Citation

Stiell IG, Walker RG, Nesbitt LP, Chapman FW, Cousineau D, Christenson J, Bradford P, Sookram S, Berringer R, Lank P, Wells GA. BIPHASIC Trial: a randomized comparison of fixed lower versus escalating higher energy levels for defibrillation in out-of-hospital cardiac arrest. Circulation. 2007 Mar 27;115(12):1511-7. doi: 10.1161/CIRCULATIONAHA.106.648204. Epub 2007 Mar 12.

Results Reference

result

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Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

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