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AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

Primary Purpose

Cardiac Arrest

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AutoPulse
Manual CPR
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, OOH-cardiac arrest, CPR, Chest compressions, Chest compression device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Washington Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Autopulse device

Manual CPR

Outcomes

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

Full Information

First Posted
June 30, 2005
Last Updated
January 26, 2011
Sponsor
University of Washington
Collaborators
Revivant Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00120965
Brief Title
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
Official Title
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
DSMB recommended termination due to lower survival to discharge in primary population and worse discharge CPC scores in the treatment arm than control arm.
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
Revivant Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac arrest, OOH-cardiac arrest, CPR, Chest compressions, Chest compression device

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1837 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Autopulse device
Arm Title
2
Arm Type
Active Comparator
Arm Description
Manual CPR
Intervention Type
Device
Intervention Name(s)
AutoPulse
Intervention Description
Standard device settings
Intervention Type
Other
Intervention Name(s)
Manual CPR
Intervention Description
Manual CPR
Primary Outcome Measure Information:
Title
Hospital admission defined as being alive four hours after the call for assistance to the emergency dispatch center.
Secondary Outcome Measure Information:
Title
ROSC (a pulse in any vessel) at any time
Title
ROSC at arrival to emergency department
Title
Admittance to the hospital
Title
Discharge from the hospital
Title
CPC score at discharge from the hospital
Title
Survival at 3 months post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred P. Hallstrom, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Clinical Trial Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16772625
Citation
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.
Results Reference
result
PubMed Identifier
20466215
Citation
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.
Results Reference
derived

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AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)

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