Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Cardiac Arrest Clinical Trial

Official title:

Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders (TIMBER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101881
• Other study ID #: 00-3776-B05
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2005
• Last updated: September 30, 2008
• Start date: November 2002
• Est. completion date: January 2005

Study information

• Verified date: September 2008
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Children

• Trauma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• Defibrillation (biphasic versus monophasic shock)
Administration of monophasic or biphasic waveform defibrillation

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Medic One Foundation

Country where clinical trial is conducted

United States, 

References & 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 defibrill — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission alive to hospital		Within hours of intervention
Secondary	Rhythm after defibrillation shock		Within minutes of intervention
Secondary	Return of spontaneous circulation		Within minutes of intervention
Secondary	Hospital discharge rates		Within days of intervention