Biphasic Defibrillation Study: Trial to Compare Fixed Versus Escalating Energy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

221 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Oxygen Interventions and Defibrillator Efficiency

NCT02317029

Atrial Fibrillation Atrial Flutter

TERMINATED NA

High Low Biphasic Energy Defibrillation (HiLoBED)

NCT00429611

Ventricular Fibrillation

UNKNOWN PHASE3

Comparison of Efficacy and Safety of Two Biphasic Defibrillators in Cardioversion of Atrial Fibrillation

NCT04032678

Atrial Fibrillation Arrythmia Electric Countershock

COMPLETED NA

AED Use in Out-of-Hospital Cardiac Arrest: A New Algorithm Named "One Shock Per Minute"

NCT00139542

Heart Arrest Ventricular Fibrillation

COMPLETED PHASE3

Temporary Epicardial Cardiac Resynchronisation.

NCT01027299

Cardiac Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fixed lower-energy

Out-of-hospital cardiac arrest patients undergoing defibrillation received a fixed lower-energy regimen of 150 J for all shocks

Group Type ACTIVE_COMPARATOR

Fixed lower-energy defibrillation

Intervention Type PROCEDURE

Every shock administered at 150 J

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

Group Type ACTIVE_COMPARATOR

Escalating higher-energy defibrillation

Intervention Type PROCEDURE

First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fixed lower-energy defibrillation

Every shock administered at 150 J

Intervention Type PROCEDURE

Escalating higher-energy defibrillation

First shock administered at 200 J, second shock at 300 J, all subsequent shocks at 360 J

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No