NCT00101881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2005

Completed
Last Updated

October 2, 2008

Status Verified

September 1, 2008

First QC Date

January 18, 2005

Last Update Submit

September 30, 2008

Conditions

Cardiac Arrest

Keywords

Cardiac arrestDefibrillationBiphasic defibrillationMonophasic defibrillationVentricular fibrillation

Outcome Measures

Primary Outcomes (1)

  • Admission alive to hospital

    Within hours of intervention

Secondary Outcomes (3)

  • Rhythm after defibrillation shock

    Within minutes of intervention

  • Return of spontaneous circulation

    Within minutes of intervention

  • Hospital discharge rates

    Within days of intervention

Study Arms (2)

Monophasic Shock

ACTIVE COMPARATOR

Administration of monophasic waveform defibrillation

Device: Defibrillation (biphasic versus monophasic shock)

Biphasic Shock

ACTIVE COMPARATOR

Administration of biphasic waveform defibrillation

Device: Defibrillation (biphasic versus monophasic shock)

Interventions

Defibrillation (biphasic versus monophasic shock)DEVICE

Administration of monophasic or biphasic waveform defibrillation

Biphasic ShockMonophasic Shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Children
  • Trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 17060379RESULT

MeSH Terms

Conditions

Heart ArrestVentricular Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Peter J Kudenchuk, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 18, 2005

First Posted

January 19, 2005

Study Start

November 1, 2002

Study Completion

January 1, 2005

Last Updated

October 2, 2008

Record last verified: 2008-09

Locations

US(1)