Clinical trial NCT00101881: Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)
Official title: Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Defibrillation
Biphasic defibrillation
Monophasic defibrillation
Ventricular fibrillation
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Medic One Foundation
First posted: 2005-01-19
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Children
* Trauma

Primary outcomes:
measure: Admission alive to hospital
timeFrame: Within hours of intervention
Secondary outcomes:
measure: Rhythm after defibrillation shock
timeFrame: Within minutes of intervention
measure: Return of spontaneous circulation
timeFrame: Within minutes of intervention
measure: Hospital discharge rates
timeFrame: Within days of intervention
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Peter J Kudenchuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.