Inhomogeneity and temporal effects in AutoPulse Assisted Prehospital International Resuscitation—an exception from consent trial terminated early

Abstract Background The ASPIRE trial (AutoPulse Assisted Prehospital International Resuscitation) was multicenter exception from consent clinical trial that compared mechanical cardiopulmonary resuscitation (CPR) with a device (AutoPulse-CPR) to traditional manual CPR (manual-CPR) in out-of-hospital...

Full description

Saved in:
Bibliographic Details
Published in:The American journal of emergency medicine 2010-05, Vol.28 (4), p.391-398
Main Authors: Paradis, Norman A., MD, Young, Gregory, MS, Lemeshow, Stanley, PhD, Brewer, James E., MS, Halperin, Henry R., MD, MA
Format: Article
Language:English
Subjects:
Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy
Automation
Biological and medical sciences
Cardiopulmonary resuscitation
Cardiopulmonary Resuscitation - instrumentation
Cardiopulmonary Resuscitation - methods
Cardiopulmonary Resuscitation - mortality
Clinical medicine
Clinical Protocols
Clinical trials
Confidence Intervals
Consent
CPR
Early Termination of Clinical Trials
Emergency
Emergency and intensive cardiocirculatory care. Cardiogenic shock. Coronary intensive care
Emergency medical care
Emergency Medical Services - methods
Equipment and Supplies
Heart Arrest - mortality
Heart Arrest - therapy
Humans
Intensive care medicine
Logistic Models
Medical sciences
Odds Ratio
Prospective Studies
Survival Analysis
Time Factors
Treatment Outcome
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Background The ASPIRE trial (AutoPulse Assisted Prehospital International Resuscitation) was multicenter exception from consent clinical trial that compared mechanical cardiopulmonary resuscitation (CPR) with a device (AutoPulse-CPR) to traditional manual CPR (manual-CPR) in out-of-hospital cardiac arrest. Enrollment was suspended early due to safety concerns. One site (site C) made a potentially important protocol change midtrial, and enrollment at that site was noted to be independently associated with outcome. Methods The study used a post hoc reanalysis of source data and documentation using standard statistical approaches evaluating for possible secular, temporal, and trial design, factors that may have related to the trial's outcome. Results The protocol change at site C also appears to have resulted in a delay in application of AutoPulse-CPR. Before and after the protocol change survival in patients receiving AutoPulse-CPR decreased from 19.6% to 4% ( P = .024). Logistic regression analysis showed site C was significantly different ( P = .008) from the remaining sites with respect to survival. Unlike site C, the other sites actually showed an increase over time in the primary end point of 4-hour survival ( P = .008) favorable to AutoPulse-CPR. There did not appear to be significant safety ( P = .42) nor efficacy concerns ( P = .17) at these sites. Conclusions The difference in survival that caused early suspension of ASPIRE appears to have been limited to one site after its protocols change. At the time the trial was suspended, the outcomes of patients at the other sites appear to have been trending in favor of the intervention.
ISSN:0735-6757
1532-8171
DOI:10.1016/j.ajem.2010.02.002