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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

NCT ID: NCT00101881

Last Updated: 2008-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-01-31

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.

Conditions

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Cardiac Arrest

Keywords

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Cardiac arrest Defibrillation Biphasic defibrillation Monophasic defibrillation Ventricular fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Monophasic Shock

Administration of monophasic waveform defibrillation

Group Type ACTIVE_COMPARATOR

Defibrillation (biphasic versus monophasic shock)

Intervention Type DEVICE

Administration of monophasic or biphasic waveform defibrillation

Biphasic Shock

Administration of biphasic waveform defibrillation

Group Type ACTIVE_COMPARATOR

Defibrillation (biphasic versus monophasic shock)

Intervention Type DEVICE

Administration of monophasic or biphasic waveform defibrillation

Interventions

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Defibrillation (biphasic versus monophasic shock)

Administration of monophasic or biphasic waveform defibrillation

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medic One Foundation

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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University of Washington

Principal Investigators

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Peter J Kudenchuk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 17060379 (View on PubMed)

Other Identifiers

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00-3776-B05

Identifier Type: -

Identifier Source: org_study_id