Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

September 30, 2008 updated by: University of Washington
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Monophasic Shock
Administration of monophasic waveform defibrillation
Device: Defibrillation (biphasic versus monophasic shock)
Administration of monophasic or biphasic waveform defibrillation
ACTIVE_COMPARATOR: Biphasic Shock
Administration of biphasic waveform defibrillation
Device: Defibrillation (biphasic versus monophasic shock)
Administration of monophasic or biphasic waveform defibrillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Admission alive to hospital
Time Frame: Within hours of intervention
Within hours of intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Medic One Foundation

Investigators

  • Principal Investigator: Peter J Kudenchuk, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

January 18, 2005

First Submitted That Met QC Criteria

January 18, 2005

First Posted (ESTIMATE)

January 19, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2008

Last Update Submitted That Met QC Criteria

September 30, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-3776-B05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Arrest

Clinical Trials on Defibrillation (biphasic versus monophasic shock)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe