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AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

University of Washington logo

University of Washington

Status and phase

Terminated
Phase 3

Conditions

Cardiac Arrest

Treatments

Other: Manual CPR
Device: AutoPulse

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00120965
03-9613-B 01

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,837 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,837 participants in 2 patient groups

1
Experimental group
Description:
Autopulse device
Treatment:
Device: AutoPulse
2
Active Comparator group
Description:
Manual CPR
Treatment:
Other: Manual CPR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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