Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Phase 4

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: Defibrillation (biphasic versus monophasic shock)

• Registration Number: NCT00101881
• Lead Sponsor: University of Washington

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-11
• Study Completion: 2005-01
• Study First Submitted: 2005-01-18
• Study First Submitted QC: 2005-01-18
• Study First Posted: 2005-01-19
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-30
• Last Update Posted: 2008-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

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

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Exclusion Criteria

• Children
• Trauma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Monophasic Shock	Defibrillation (biphasic versus monophasic shock)	Administration of monophasic waveform defibrillation
Biphasic Shock	Defibrillation (biphasic versus monophasic shock)	Administration of biphasic waveform defibrillation

Primary Outcome Measures

Name	Time	Method
Admission alive to hospital	Within hours of intervention

Secondary Outcome Measures

Name	Time	Method
Rhythm after defibrillation shock	Within minutes of intervention
Return of spontaneous circulation	Within minutes of intervention
Hospital discharge rates	Within days of intervention

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States