AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

Sponsor

University of Washington (Other)

Overall Status

Terminated

CT.gov ID

NCT00120965

Collaborator

Revivant Corporation (Industry)

1,837

Enrollment

Location

Arms

Duration (Months)

204.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 1, 2004

Actual Study Completion Date :

Mar 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Autopulse device	Device: AutoPulse Standard device settings
Active Comparator: 2 Manual CPR	Other: Manual CPR Manual CPR

Arm

Intervention/Treatment

Experimental: 1

Autopulse device

Device: AutoPulse

Standard device settings

Active Comparator: 2

Manual CPR

Other: Manual CPR

Manual CPR

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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