Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00212992
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 64
• Patients Per Site Per Month: 3.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Procedure: fixed versus escalating biphasic defibrillation	Phase 3

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.

1. Process Outcomes:

• Number of shocks required,

• Recurrences of VF, and

• Responsiveness to varying periods of pulselessness.

1. Adverse Outcomes:

• Myocardial damage.

Study Design

• Study Type: Interventional
• 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
• Actual Study Start Date: Mar 1, 2001
• Actual Primary Completion Date: Sep 1, 2005
• Actual Study Completion Date: Jul 1, 2006

Outcome Measures

Primary Outcome Measures

1. Successful conversion to an organized heart rhythm []

Secondary Outcome Measures

1. Survival to hospital discharge []

2. Resuscitation for survival to one hour []

3. Neurologic function []

4. Removal of ventricular fibrillation (VF) in 5 seconds []

5. Return of spontaneous circulation []

6. Survival to 24 hours []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ottawa Hospital	Ottawa	Ontario	Canada	K1Y 4E9

Sponsors and Collaborators

• Ottawa Hospital Research Institute

Investigators

• Principal Investigator: Ian Stiell, MD, OHRI

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT00212992
• Other Study ID Numbers: 2001266-01H
• First Posted: Sep 21, 2005
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Jan 24, 2017