Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120965
Status:
TERMINATED
Last Update Posted:
2011-01-27
First Post:
2005-06-30
Brief Title:
AutoPulse Assisted Prehospital International Resuscitation Trial ASPIRE
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
AutoPulse Assisted Prehospital International Resuscitation Trial ASPIRE
Status:
TERMINATED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The AutoPulse Assisted Prehospital International Resuscitation ASPIRE Trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device AutoPulse during the resuscitative attempt following out-of-hospital cardiac arrest
Detailed Description:
Extensive early experience yielded no reliably validated instances of out-of-hospital arrest associated with tachyarrhythmia being resuscitated without successful defibrillatory shock This together with the increasing availability of automated external defibrillators AEDs at increasingly attractive prices led in the past decade to a strong emphasis on early defibrillation This emphasis may have inadvertently resulted in a decreased emphasis on cardiopulmonary resuscitative techniques particularly in light of publications decrying the uniformly poor quality of CPR performed by laymen medical professionals and even EMS personnel However recent research strongly suggests that assisted reperfusion prior to defibrillation may actually significantly improve survival rates These reports based on clinical studies have received substantial confirmation from carefully controlled laboratory studies particularly in pigs
If assisted reperfusion prior to defibrillation and subsequent to failed shock is important it is reasonable to suppose that the benefit is related to quality of chest compressions Observations of resuscitative efforts in the field indicate that maintaining compressions is one of the more difficult tasks for a variety of reasons Observations in the laboratory with trained paramedics show that the depth of compression and the compression rate diminish rapidly with time from the onset of CPR without the participant being aware that hisher effort is actually diminished
The desire to provide consistent and quality compressions has led to the development of a mechanical compression assist device called the AutoPulse It is a self-contained portable chest compression device that is rapidly field deployable
If assisted reperfusion prior to defibrillation and subsequent to failed shock is important it is reasonable to suppose that the benefit is related to quality of chest compressions Observations of resuscitative efforts in the field indicate that maintaining compressions is one of the more difficult tasks for a variety of reasons Observations in the laboratory with trained paramedics show that the depth of compression and the compression rate diminish rapidly with time from the onset of CPR without the participant being aware that hisher effort is actually diminished
The desire to provide consistent and quality compressions has led to the development of a mechanical compression assist device called the AutoPulse It is a self-contained portable chest compression device that is rapidly field deployable
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