AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT00120965|
Recruitment Status : Terminated (DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm.)
First Posted : July 19, 2005
Last Update Posted : January 27, 2011
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Device: AutoPulse Other: Manual CPR||Phase 3|
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 his/her 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1837 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)|
|Study Start Date :||June 2004|
|Actual Study Completion Date :||March 2005|
Standard device settings
Active Comparator: 2
Other: Manual CPR
- Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
- ROSC (a pulse in any vessel) at any time
- ROSC at arrival to emergency department
- Admittance to the hospital
- Discharge from the hospital
- CPC score at discharge from the hospital
- Survival at 3 months post hospital discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120965
|United States, Washington|
|University of Washington Clinical Trial Center|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Alfred P. Hallstrom, PhD||University of Washington|