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| Name | Class |
|---|---|
| Medic One Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monophasic Shock | Active Comparator | Administration of monophasic waveform defibrillation |
|
| Biphasic Shock | Active Comparator | Administration of biphasic waveform defibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillation (biphasic versus monophasic shock) | Device | Administration of monophasic or biphasic waveform defibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Admission alive to hospital | Within hours of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Rhythm after defibrillation shock | Within minutes of intervention | |
| Return of spontaneous circulation | Within minutes of intervention | |
| Hospital discharge rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter J Kudenchuk, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17060379 | Result | Kudenchuk PJ, Cobb LA, Copass MK, Olsufka M, Maynard C, Nichol G. Transthoracic incremental monophasic versus biphasic defibrillation by emergency responders (TIMBER): a randomized comparison of monophasic with biphasic waveform ascending energy defibrillation for the resuscitation of out-of-hospital cardiac arrest due to ventricular fibrillation. Circulation. 2006 Nov 7;114(19):2010-8. doi: 10.1161/CIRCULATIONAHA.106.636506. Epub 2006 Oct 23. |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004554 | Electric Countershock |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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| Within days of intervention |
| D013568 |
| Pathological Conditions, Signs and Symptoms |