Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Defibrillation (biphasic versus monophasic shock)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult victims of nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation Exclusion Criteria: Children Trauma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Monophasic Shock<br>Administration of monophasic waveform defibrillation | Device: Defibrillation (biphasic versus monophasic shock)<br>* Administration of monophasic or biphasic waveform defibrillation<br>|
| Active Comparator: Biphasic Shock<br>Administration of biphasic waveform defibrillation | Device: Defibrillation (biphasic versus monophasic shock)<br>* Administration of monophasic or biphasic waveform defibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Admission alive to hospital |  | Within hours of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhythm after defibrillation shock |  | Within minutes of intervention | 
| Return of spontaneous circulation |  | Within minutes of intervention | 
| Hospital discharge rates |  | Within days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Defibrillation, Biphasic defibrillation, Monophasic defibrillation, Ventricular fibrillation