Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

University of Washington

Status and phase: Completed; Phase 4

Conditions: Cardiac Arrest

Treatments: Device: Defibrillation (biphasic versus monophasic shock)

Study type: Interventional

Funder types: Other

Identifiers

NCT00101881

00-3776-B05

Details and patient eligibility

About

The study compares the effectiveness of two fully approved shock waveforms (monophasic and biphasic shock) commonly used to defibrillate (shock) patients with out-of-hospital cardiac arrest due to a highly lethal rhythm problem (ventricular fibrillation). The purpose of the study (hypothesis) is to determine if one waveform results in improved resuscitation, admission alive to hospital, and discharge alive from hospital compared with the other.

Full description

The trial is designed to determine whether two fully-FDA-approved, commercially available transthoracic defibrillation shock waveforms at comparable energies result in improved patient outcome following out-of-hospital cardiac arrest due to ventricular fibrillation. Eligible subjects include all adults with nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation. Subjects in cardiac arrest will be randomly allocated to receive one of two types of defibrillation shocks (monophasic or biphasic waveform) during their resuscitation, which will in addition include all other standard treatments. The primary endpoint is admission alive to hospital. Secondary endpoints include rhythm after defibrillation shock, return of spontaneous circulation, and hospital discharge rates.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult victims of nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation

Exclusion criteria

• Children
• Trauma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups

Monophasic Shock

Active Comparator group

Description:

Administration of monophasic waveform defibrillation

Treatment:

Device: Defibrillation (biphasic versus monophasic shock)

Biphasic Shock

Active Comparator group

Description:

Administration of biphasic waveform defibrillation

Treatment:

Device: Defibrillation (biphasic versus monophasic shock)