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Home > "P" Clinical Trials Conditions > Public Access Defibrillation (PAD) Community Trial  Public Access Defibrillation (PAD) Community Trial
Public Access Defibrillation (PAD) Community Trial
For Condition: Heart Arrest,Heart Diseases,Myocardial Infarction,Arrhythmia,Death, Sudden, Cardiac,Ventricular Fibrillation
Status: No longer recruiting
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To measure survival to hospital discharge of patients with out-of-hospital cardiac arrest in community units (e.g., apartment or office buildings, gated communities, sports venues, senior centers, shopping malls) served by trained non-medical responders using automated external defibrillators (AEDs), an approach called Public Access Defibrillation, compared to units receiving the traditional optimum community standard of care (i.e., rescuers trained to recognize a cardiac emergency, call 911, and initiate CPR).
Details: BACKGROUND: Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency resuscitation are inadequate due to time delays inherent in the transport of a trained responder with defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS) systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. Such an approach typically varies in effectiveness, with an incremental improvement in effectiveness seen in communities that organize and integrate services with the existing EMS system. However, optimal improvement in survival from sudden OOH-CA may require a program that utilizes volunteer non-medical responders (who may not have a traditional duty to respond to an emergency) who are succesfully trained to use AEDs. A comprehensive, integrated community approach to treatment with AEDs would have community units served by these volunteer non-medical responders who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD). Some observational studies suggest support for the PAD approach. These studies have targeted traditional public safety responders such as police and firefighters or other laypersons in leadership positions who are trained and regularly called upon to take command in an emergency (e.g., airline flight attendants, security officers in Las Vegas casinos). Other studies, both randomized and observational, where trainees have been spouses or family members of at-risk patients, suggest that not all laypersons can effectively utilize AEDs in the setting of OOH-CA, even with extensive training. This study differs from those conducted previously by focusing on an intermediate group, namely, volunteer non-medical responders (e.g., merchants, bank tellers, building superintendents, and co-workers). This study will provide results that may help to develop informed public policy regarding the use of AEDs by volunteer non-medical persons. DESIGN NARRATIVE: This is a study of a comprehensive, integrated community approach in which volunteer non-medical responders (lay volunteers without a traditional responsibility to take charge in medical emergencies as their primary job description) are trained to use automated external defibrillators (AEDs). This approach is called Public Access Defibrillation (PAD). The hypothesis to be investigated is that PAD will significantly increase survival in out-of-hospital cardiac arrest by reducing the time interval from collapse to defibrillation. The specific aim of this randomized, controlled trial is to measure survival to hospital discharge following out-of-hospital cardiac arrest in community units trained and equipped to provide public access defibrillation in addition to optimal standard care, compared to community units trained to provide optimal standard care (recognition of out-of-hospital cardiac arrest, 911 access, cardiopulmonary resuscitation). Secondary aims include the comparison using Utstein criteria (Annals of Emergency Medicine 1991;20:861-74), neurological status, quality of life, cost, and cost-effectiveness between the two groups. Participating research sites have identified 1,000 units (e.g., public areas, gated communities, shopping malls, airport terminals, casinos, business parks) within their service area that anticipate at least 0.6 treatable out-of-hospital cardiac arrests within a 15 month period. Each unit will be randomized to serve as either an intervention or control group, with comparative episode data collected for a 15 month period following a short preliminary data collection period (approximately 2 months to evaluate the ability for the site to capture event data) after training. Within each site, units will be sub-randomized to a retraining strategy. Performance at retraining will be monitored, and strategies modified if indicated. Volunteer non-medical responders (e.g., office staff, bank tellers, merchants, and neighborhood volunteers) in both the intervention and control groups will be trained to provide the optimal standard of care: (a) recognize out-of-hospital cardiac arrest; (b) access 911 or its equivalent; and, (c) administer CPR. Volunteers in the intervention group will also be taught to use an AED promptly while awaiting arrival of the first public safety emergency medical team. The criteria for number and location of trained volunteers and devices will be a maximum 3-minute "walk through" to have the AED at the patient's side. Out-of-hospital cardiac arrest victims in each of the two groups will be compared over the 15 month intervention period with respect to their: (a) survival to hospital discharge (primary outcome); (b) neurological status; (c) quality of life; and, (d) resource use/costs. The incremental cost-effectiveness of volunteer non-medical responder defibrillation will be calculated.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 128;
Study Start Date: September 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004560
Other Myocardial Infarction Studies:
1. Prognostic Significance of T Wave Alternans
2. Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)
3. Fatty Acid Antiarrhythmia Trial (FAAT)
4. Beta-Blocker Heart Attack Trial (BHAT)
5. Antiarrhythmic Effects of N-3 Fatty Acids
Related Studies:
Other Myocardial Infarction Clinical Trials
Other Clinical Trials
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Public Access Defibrillation (PAD) Community Trial
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