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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Defibrillation (biphasic versus monophasic shock)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Defibrillation, Biphasic defibrillation, Monophasic defibrillation, Ventricular fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult victims of nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation Exclusion Criteria: Children Trauma

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Monophasic Shock

Biphasic Shock

Arm Description

Administration of monophasic waveform defibrillation

Administration of biphasic waveform defibrillation

Outcomes

Primary Outcome Measures

Admission alive to hospital

Secondary Outcome Measures

Rhythm after defibrillation shock
Return of spontaneous circulation
Hospital discharge rates

Full Information

First Posted
January 18, 2005
Last Updated
September 30, 2008
Sponsor
University of Washington
Collaborators
Medic One Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00101881
Brief Title
Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)
Official Title
Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
Medic One Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac arrest, Defibrillation, Biphasic defibrillation, Monophasic defibrillation, Ventricular fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Monophasic Shock
Arm Type
Active Comparator
Arm Description
Administration of monophasic waveform defibrillation
Arm Title
Biphasic Shock
Arm Type
Active Comparator
Arm Description
Administration of biphasic waveform defibrillation
Intervention Type
Device
Intervention Name(s)
Defibrillation (biphasic versus monophasic shock)
Intervention Description
Administration of monophasic or biphasic waveform defibrillation
Primary Outcome Measure Information:
Title
Admission alive to hospital
Time Frame
Within hours of intervention
Secondary Outcome Measure Information:
Title
Rhythm after defibrillation shock
Time Frame
Within minutes of intervention
Title
Return of spontaneous circulation
Time Frame
Within minutes of intervention
Title
Hospital discharge rates
Time Frame
Within days of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult victims of nontraumatic out-of-hospital cardiac arrest due to ventricular fibrillation Exclusion Criteria: Children Trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J Kudenchuk, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17060379
Citation
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.
Results Reference
result

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Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

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