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Completed

NCT Number: NCT00101881

Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

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.

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Key information

Conditions

Cardiac Arrest Arrhythmias, Cardiac Cardiovascular Diseases Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Children
  • Trauma

Treatment and study plan

Defibrillation (biphasic versus monophasic shock)

Device

Administration of monophasic or biphasic waveform defibrillation

Primary outcomes

  1. Admission alive to hospital

    Time frame: Within hours of intervention

Secondary outcomes

  1. Rhythm after defibrillation shock

    Time frame: Within minutes of intervention

  2. Return of spontaneous circulation

    Time frame: Within minutes of intervention

  3. Hospital discharge rates

    Time frame: Within days of intervention

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Medic One Foundation

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Jan 19, 2005
Registry last updated
Oct 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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