Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101881
Status:
COMPLETED
Last Update Posted:
2008-10-02
First Post:
2005-01-18
Brief Title:
Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders TIMBER
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Transthoracic Incremental Monophasic Versus Biphasic by Emergency Responders TIMBER
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None