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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

This study has been completed.
Sponsor:
Collaborator:
Medic One Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00101881
First received: January 18, 2005
Last updated: September 30, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Cardiac Arrest
 Device: Defibrillation (biphasic versus monophasic shock)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Admission alive to hospital [ Time Frame: Within hours of intervention ]

Secondary Outcome Measures:
  • Rhythm after defibrillation shock [ Time Frame: Within minutes of intervention ]
  • Return of spontaneous circulation [ Time Frame: Within minutes of intervention ]
  • Hospital discharge rates [ Time Frame: Within days of intervention ]

Enrollment: 168
Study Start Date: November 2002
Study Completion Date: January 2005
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Children
  • Trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101881

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Medic One Foundation
Investigators
Principal Investigator: Peter J Kudenchuk, MD University of Washington
  More Information

Publications:

Responsible Party: Peter J. Kudenchuk, MD, University of Washington
ClinicalTrials.gov Identifier: NCT00101881     History of Changes
Other Study ID Numbers: 00-3776-B05
Study First Received: January 18, 2005
Last Updated: September 30, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Cardiac arrest
Defibrillation
Biphasic defibrillation
Monophasic defibrillation
Ventricular fibrillation

Additional relevant MeSH terms:
Emergencies
Heart Arrest
Disease Attributes
 Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013