AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

NCT ID: NCT00120965

Last Updated: 2011-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1837 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-03-31

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.

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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Autopulse device

Group Type: EXPERIMENTAL

AutoPulse

Intervention Type: DEVICE

Standard device settings

2

Manual CPR

Group Type: ACTIVE_COMPARATOR

Manual CPR

Intervention Type: OTHER

Manual CPR

Interventions

AutoPulse

Standard device settings

Intervention Type: DEVICE

Manual CPR

Manual CPR

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revivant Corporation

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Principal Investigators

Alfred P. Hallstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Clinical Trial Center

Seattle, Washington, United States

Countries

United States

References

Hallstrom A, Rea TD, Sayre MR, Christenson J, Anton AR, Mosesso VN Jr, Van Ottingham L, Olsufka M, Pennington S, White LJ, Yahn S, Husar J, Morris MF, Cobb LA. Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial. JAMA. 2006 Jun 14;295(22):2620-8. doi: 10.1001/jama.295.22.2620.

Reference Type: RESULT

PMID: 16772625 (View on PubMed)

Paradis NA, Young G, Lemeshow S, Brewer JE, Halperin HR. Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation--an exception from consent trial terminated early. Am J Emerg Med. 2010 May;28(4):391-8. doi: 10.1016/j.ajem.2010.02.002.

Reference Type: DERIVED

PMID: 20466215 (View on PubMed)

Other Identifiers

03-9613-B 01

Identifier Type: -

Identifier Source: org_study_id