AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

This study has been 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.)
Sponsor:
Collaborator:
Revivant Corporation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00120965
First received: June 30, 2005
Last updated: January 26, 2011
Last verified: January 2011

June 30, 2005
January 26, 2011
June 2004
Not Provided
Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
Same as current
Complete list of historical versions of study NCT00120965 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Arrest
  • Device: AutoPulse
    Standard device settings
  • Device: Autopulse
    Standard device settings
  • Other: Manual CPR
    Manual CPR
  • Experimental: 1
    Autopulse device
    Interventions:
    • Device: AutoPulse
    • Device: Autopulse
  • Active Comparator: 2
    Manual CPR
    Intervention: Other: Manual CPR

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1837
March 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120965
03-9613-B 01
Yes
Not Provided
University of Washington
Revivant Corporation
Principal Investigator: Alfred P. Hallstrom, PhD University of Washington
University of Washington
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP