Cardiac Arrest Clinical Trial
Official title:
AutoPulse Assisted Prehospital International Resuscitation Trial (ASPIRE)
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 |
The AutoPulse Assisted Prehospital International Resuscitation (ASPIRE) Trial compares the efficacy of circulatory assist by manual chest compression versus an automated chest compression device (AutoPulseā¢) during the resuscitative attempt following out-of-hospital cardiac arrest.
Status | Terminated |
Enrollment | 1837 |
Est. completion date | March 2005 |
Est. primary completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Clinical Trial Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Revivant Corporation |
United States,
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
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 |
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