AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

Cardiac Arrest Clinical Trial

Official title:

AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00120965
• Other study ID #: 03-9613-B 01
• Status: Terminated
• Phase: Phase 3
• First received: June 30, 2005
• Last updated: January 26, 2011
• Start date: June 2004
• Est. completion date: March 2005

Study information

• Verified date: January 2011
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1837
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• AutoPulse
Standard device settings

Other:
• Manual CPR
Manual CPR

Locations

Country	Name	City	State
United States	University of Washington Clinical Trial Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Revivant Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
Secondary	ROSC (a pulse in any vessel) at any time
Secondary	ROSC at arrival to emergency department
Secondary	Admittance to the hospital
Secondary	Discharge from the hospital
Secondary	CPC score at discharge from the hospital
Secondary	Survival at 3 months post hospital discharge