AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Revivant Corporation
Information provided by:
University of Washington

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Device: AutoPulse Other: Manual CPR Phase 3

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
Study Start Date : June 2004
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: 1
Autopulse device
Device: AutoPulse
Standard device settings

Active Comparator: 2
Manual CPR
Other: Manual CPR
Manual CPR

Primary Outcome Measures :
  1. Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.

Secondary Outcome Measures :
  1. ROSC (a pulse in any vessel) at any time
  2. ROSC at arrival to emergency department
  3. Admittance to the hospital
  4. Discharge from the hospital
  5. CPC score at discharge from the hospital
  6. Survival at 3 months post hospital discharge

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All persons with out-of-hospital cardiac arrest who are attended by a vehicle involved in the randomization process and who are treated by the emergency medical service (EMS).

Exclusion Criteria:

  • Persons under the age of 18
  • Victims with traumatic arrest
  • Less than the legal age of consent
  • Resuscitation attempt discontinued because of do not resuscitate (DNR) orders or on request of authorized decision-maker
  • Wards of the state, including prisoners
  • Chest or abdominal surgery within 6 weeks
  • Site specific exclusions

Information from the National Library of Medicine

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 identifier (NCT number): NCT00120965

United States, Washington
University of Washington Clinical Trial Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Revivant Corporation
Principal Investigator: Alfred P. Hallstrom, PhD University of Washington

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00120965     History of Changes
Other Study ID Numbers: 03-9613-B 01
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: January 27, 2011
Last Verified: January 2011

Keywords provided by University of Washington:
Cardiac arrest
OOH-cardiac arrest
Chest compressions
Chest compression device

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases