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
  Purpose

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 Intervention Phase
Cardiac Arrest
Device: AutoPulse
Device: Autopulse
Other: Manual CPR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

Resource links provided by NLM:


Further study details as provided by University of Washington:

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

Secondary Outcome Measures:
  • 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

Enrollment: 1837
Study Start Date: June 2004
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: 1
Autopulse device
Device: AutoPulse
Standard device settings
Device: Autopulse
Standard device settings
Active Comparator: 2
Manual CPR
Other: Manual CPR
Manual CPR

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120965

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00120965     History of Changes
Other Study ID Numbers: 03-9613-B 01
Study First Received: June 30, 2005
Last Updated: January 26, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014