Locations of cardiac arrest: affirmation for community Public Access Defibrillation (PAD) Program

BACKGROUND: The purpose of this study was to describe the regional locations of cardiac arrest, and to identify public locations and the annual incidence of arrests within the identified locations, in order to help to determine optimal placement of Automatic External Defibrillators (AEDs) under the regional Public Access Defibrillation (PAD) Program. This is a retrospective study. METHODS: The locations of cardiac arrest were abstracted from Ambulance Call Reports (ACRs) collected by the Essex-Kent Base Hospital Centre from regional ambulance services throughout the City of Windsor, and the Counties of Essex and Kent, Ontario, Canada, from 01 January 1994 through 31 December 2000. Arrest locations were grouped into five categories, and then the number of public venues was determined. Public Sites were grouped into 28 Public Locations. Also included in the Public Sites were both General Industry and Outdoors categories. Categories identified but excluded from Public Sites were Institutions and Private Residences. RESULTS: During the study, 2,295 arrests occurred, 152 cases were excluded, 2,142 arrests were categorized, (average annual incidence of 306 +/- 50.4 cardiac arrests), 329 (15.4%) of which were in Public Sites. Nineteen public venues had an average of > 1 arrest/year, and nine public venues had an average of < or = 1 arrest/year during the study, period. Calculations of the annual incidence of arrests for each public location were completed. CONCLUSIONS: These findings have significant prehospital emergency cardiac care implications for communities that wish to strengthen/improve their responses to out-of-hospital cardiac arrests. Public Access Defibrillation Programs should identify the site-specific incidence of arrest within their communities in order to provide legitimacy for funding and planning of programs. Training and availability of AEDs will reduce the time to first shock, thus strengthening the chain-of-survival and will save more lives.     

Conducting research using the emergency exception from informed consent: the Public Access Defibrillation (PAD) Trial experience

BACKGROUND: The Public Access Defibrillation (PAD) Trial, a prospective, multicenter, randomized clinical trial comparing two prehospital resuscitation strategies, was conducted under the regulations for exception from informed consent (21CFR50.24) in 24 communities in North America. These regulations place additional requirements for human subject protection on investigators and Institutional Review Boards (IRBs), including conducting community consultation (CC) and public disclosure (PD). OBJECTIVE: To describe the IRB approval process at study sites and the number and types of community consultation and public disclosure activities conducted. METHODS: The 24 study sites in the United States and Canada submitted IRB applications, CC and PD plans, and a structured report on IRB process and investigator perceptions to the Clinical Trial Center at the University of Washington. RESULTS: The primary IRBs for all 24 trial sites and a total of 101 IRBs approved the study. The median interval from submission to approval was 108 days (IQR 43-196), and the mean number of revisions was two (range 0-7). Investigators conducted nearly 12,000 activities to achieve CC and PD; activities varied greatly from site to site in both type and quantity. CONCLUSION: The length of time to obtain IRB approval and the extent of community consultation and public disclosure varied greatly among trial sites in meeting the current regulations for conducting emergency research with exception from informed consent. This suggests that more specific guidance may be useful and that determination of effective strategies for community consultation and public disclosure is needed.     

How Well are Cardiopulmonary Resuscitation and Automated External Defibrillator Skills Retained over Time? Results from the Public Access Defibrillation (PAD) Trial

Background: The current standard for cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) retraining for laypersons is a four‐hour course every two years. Others have documented substantial skill deterioration during this time period. Objectives: To evaluate 1) the retention of core CPR and AED skills among volunteer laypersons and 2) the time required to retrain laypersons to proficiency as a function of time since initial training. Methods: This was an observational follow‐up study evaluating CPR and AED skill retention and testing/retraining time up through 17 months after initial training. The study took place at 1,260 facilities recruited by 24 North American clinical research centers, and included 6,182 volunteer laypersons participating in the Public Access Defibrillation (PAD) Trial. Training to proficiency in either CPR only (N= 2,426) or CPR+AED (N= 3,756) was followed by testing/retraining provided three to 17 months later. Retraining was done in brief, one‐on‐one, individualized, interactive sessions. The outcome studied was instructors' global assessments of performance of CPR and AED skill adequacy, i.e., whether CPR actions would likely result in perfusion (yes/no) and whether AED actions would result in a shock through the heart (yes/no). Results: For global CPR performance, 79%, 73%, and 71% of volunteers tested for the first time since initial training three to five, six to 11, and 12 to 17 months after initial training, respectively, were judged by their instructors as having adequate performance (p < 0.001, chi‐square for linear trend). For global AED performance, 91%, 86%, and 84% of volunteers, respectively, were judged as having adequate performance (p < 0.001). The mean (± standard deviation) times required to test and retrain volunteers to proficiency were 5.7 (± 4.0) minutes for CPR skills and 7.7 (± 4.6) minutes for CPR+AED skills. Conclusions: Among PAD Trial volunteer laypersons participating in a simulated resuscitation, the proportions of volunteers judged by instructors to have adequate CPR and AED skills demonstrated small declines associated with longer intervals between initial training and subsequent testing. However, based on instructors' judgment, large majorities of volunteers still retained both CPR and AED core skills through 17 months after initial training. Furthermore, individual testing and retraining for CPR and AED skills were usually accomplished in less than 10 minutes per volunteer. Additional research is essential to identify training and evaluation techniques that predict adequate CPR and AED skill performance of laypersons when applied to an actual cardiac arrest.     

Public Access Defibrillation: Great benefit and potential but infrequently used

BackgroundIn Copenhagen, a volunteer-based Automated External Defibrillator (AED) network provides a unique opportunity to assess AED use.We aimed to determine the proportion of Out-of-Hospital Cardiac Arrest (OHCA) where an AED was applied before arrival of the ambulance, and the proportion of OHCA-cases where an accessible AED was located within 100 m. In addition, we assessed 30-day survival.MethodsUsing data from the Mobile Emergency Care Unit and the Danish Cardiac Arrest Registry, we identified 521 patients with OHCA between October 1, 2011 and September 31, 2013 in Copenhagen, Denmark.ResultsAn AED was applied in 20 cases (3.8%, 95% CI [2.4 to 5.9]). Irrespective of AED accessibility, an AED was located within 100 m of a cardiac arrest in 23.4% (n = 102, 95% CI [19.5 to 27.7]) of all OHCAs. However, at the time of OHCA, an AED was located within 100 m and accessible in only 15.1% (n = 66, 95% CI [11.9 to 18.9]) of all cases.The 30-day survival for OHCA with an initial shockable rhythm was 64% for patients where an AED was applied prior to ambulance arrival and 47% for patients where an AED was not applied.ConclusionsWe found that 3.8% of all OHCAs had an AED applied prior to ambulance arrival, but 15.1% of all OHCAs occurred within 100 m of an accessible AED. This indicates the potential of utilising AED networks by improving strategies for AED accessibility and referring bystanders of OHCA to existing AEDs.     

The Initiating Dialysis Early and Late (IDEAL) study: study rationale and design.

OBJECTIVES: The primary objective of the IDEAL study is to determine whether the timing of dialysis initiation has an effect on survival in subjects with end-stage renal disease (ESRD). The secondary objectives are to determine the impact of "early start" versus "late start" dialysis on nutritional and cardiac morbidity, quality of life, and economic cost. DESIGN: Prospective multicenter randomized controlled trial. Patients are randomized to commence dialysis at a glomerular filtration rate (by Cockcroft-Gault) of either 10-14 mL/minute/1.73 m2 ("early start") or 5-7 mL/min/1.73 m2 ("late start"), with stratification for dialysis modality (hemodialysis vs peritoneal dialysis), study center, and the presence or not of diabetes mellitus. SETTING: Dialysis units throughout Australia and New Zealand. PATIENTS: Patients with ESRD commencing chronic dialysis therapy. OUTCOME MEASURES: Three years from randomization, all-cause mortality, morbidity, and economic impact; structural and functional cardiac status, nutritional state, and quality of life will be assessed. RESULTS: To date, 388 patients of a minimum 800 patients have been entered and randomized into the study. Current recruitment rates suggest sufficient patients will be enrolled by December 2004 and follow-up completed by December 2007. CONCLUSIONS: The IDEAL study will provide evidence for the optimal time to commence dialysis.     

A randomized trial of Evidence-based OutReach (EBOR): rationale and design.

There is increasing interest in evaluating the methods used to implement the findings from medical research. This paper describes the Evidence-based OutReach (EBOR) trial, which is the first large randomized study in the United Kingdom that will evaluate the effectiveness and efficiency of educational outreach visits by trained pharmacists who are delivering messages derived from four evidence-based clinical practice guidelines. General practices form the unit of allocation and analysis. The study design addresses important factors that may influence the effectiveness of the intervention, such as the pharmacist who delivers the messages, the health authority in which practices are located, and the size of a practice.     

The rationale and design of the SMART CRT trial

Aims

The SMART CRT study will assess the efficacy of an atrioventricular optimization algorithm to improve reverse remodeling among patients undergoing cardiac resynchronization therapy (CRT) in the presence of interventricular electrical delay.

Methods and results

The SMART CRT study is a global, multicenter, prospective, randomized study of patients undergoing CRT implantation. The primary endpoint of this trial is response rate to CRT, defined as decrease in left ventricular end‐systolic volume (LVESV) ≥15% at 6 months compared to preimplant baseline. Additional prespecified analyses are: (1) clinical composite endpoint combining all‐cause mortality, heart failure events, New York Heart Association class, and Quality of Life (using a patient global assessment instrument); (2) the individual components of the clinical composite endpoint; (3) 6‐minute walk distance; (4) Kansas City Cardiomyopathy Questionnaire; (5) LVESV as a continuous variable; and (6) absolute left‐ventricular ejection fraction. Subjects with intraventricular delay ≥ 70 ms measured between the right ventricular and left ventricular pacing leads will be randomized in a 1:1 ratio to have either an AV Delay and pacing chamber determined by SmartDelay? or a Fixed AV Delay of 120 ms with biventricular pacing. Enrollment of an estimated 726 of subjects from up to 100 centers worldwide is planned to achieve 436 randomized subjects and 370 complete data sets required to power the primary endpoint.

Conclusions

This trial will provide important data regarding the importance of AV Delay programming in patients with prolonged interventricular delay at the pacing sites.

     

Location of Cardiac Arrests in the Public Access Defibrillation Trial

Background. The Public Access Defibrillation (PAD) Trial found an overall doubling in the number of out-of-hospital cardiac arrest (CA) survivors when a lay responder team was equipped with an automated external defibrillator (AED), compared with cardiopulmonary resuscitation (CPR) alone. Objectives. To describe the types of facilities that participated in the trial andto report the incidence of CA andsurvival in these different types of facilities. Methods. In this post-hoc analysis of PAD Trial data, the physical characteristics of the participating facilities andthe numbers of presumed CAs, treatable CAs, andsurvivors are reported for each category of facilities. Results. There were 625 presumed CAs at 1,260 participating facilities. Just under half (n = 291) of the presumed CAs were classified as treatable CAs. Treatable CAs occurred at a rate of 2.9 per 1,000 person-years of exposure; rates were highest in fitness centers (5.1) andgolf courses (4.8) andlowest in office complexes (0.7) andhotels (0.7). Survival from treatable CA was highest in recreational complexes (0.5), public transportation sites (0.4), andfitness centers (0.4) andlowest in office complexes (0.1) andresidential facilities (0.0). Conclusions. During the PAD Trial, the exposure-adjusted rate of treatable CA was highest in fitness centers andgolf courses, but the incidence per facility was low to moderate. Survival from treatable cardiac arrest was highest in recreational complexes, public transportation facilities, andfitness centers.     

Inflammation and exercise (INFLAME): study rationale, design, and methods

PurposeThe INFLAME study is designed to determine the effect of exercise training on elevated high-sensitivity C-Reactive Protein (CRP) concentrations in initially sedentary women and men.MethodsINFLAME will recruit 170 healthy, sedentary women and men with elevated CRP (≥ 2.0 mg/L) to be randomized to either an exercise group or non-exercise control group. Exercising individuals will participate in four months of supervised aerobic exercise with a total energy expenditure of 16 kcal kg^− 1 week^− 1 (KKW). Exercise intensity will be 60–80% of maximal oxygen consumption (VO₂ max).OutcomeThe primary outcome will be changed in plasma CRP concentration. Secondary outcomes include visceral adiposity, the cytokines IL-6 and TNF-α, and heart rate variability (HRV) in order to examine potential biological mechanisms whereby exercise might affect CRP concentrations.SummaryINFLAME will help us understand the effects of moderate-to-vigorous exercise on CRP concentrations in sedentary individuals. To our knowledge this will be the largest training study specifically designed to examine the effect of exercise on CRP concentrations. This study has the potential to influence therapeutic applications since CRP measurement is becoming an important clinical measurement in Coronary Heart Disease risk assessment. This study will also contribute to the limited body of literature examining the effect of exercise on the variables of visceral adiposity, cytokines, and heart rate variability.     

Public access to defibrillation (PAD): implementing a church program

For every minute without cardiopulmonary resuscitation and defibrillation, the odds of surviving cardiac arrest decrease by 7% to 10%. Churches can implement a public access to defibrillation (PAD) program and help save lives. This article outlines steps and resources for setting up a PAD program.     

The inhaled Steroid Treatment as Regular Therapy in early asthma (START) study: rationale and design

Although the beneficial effects of treatment with inhaled steroids in asthma are widely accepted, the role of early intervention in patients with mild asthma remains unsettled. Conventional efficacy trials are often of short duration and involve highly selected patient populations that exclude many patients typical of those encountered in routine clinical practice. Hence, a large "real-world" effectiveness study is needed to evaluate the benefits of early intervention with inhaled steroids in patients with mild, persistent asthma. In the START (inhaled Steroid Treatment As Regular Therapy in early asthma) study, patients ages 6-60 years, from 31 countries and districts worldwide with mild persistent asthma, have been randomized to once-daily treatment with budesonide, 200 microg (for patients < 11 years) or 400 microg (for patients > or = 11 years), or placebo via Turbuhaler for 3 years. The double-blind treatment period will be followed by a 2-year period of open budesonide treatment. Throughout the study, other asthma medication including glucocorticosteroids can be given as judged appropriate by the investigator. Lung function will be measured by spirometry using standardized techniques at 3-month intervals throughout the study, and bronchodilator reversibility will be measured annually. The primary outcome measures are the time to the first severe asthma-related event during the first 3 years of the study and the change in postbronchodilator forced expiratory volume in 1 second (FEV(1)) from baseline during the entire 5-year study period. These measures have been chosen to reflect the progression of mild asthma toward more severe asthma and the extent of irreversible airflow limitation, which should reflect the degree of airway remodeling.     

Characteristics of volunteers responding to emergencies in the Public Access Defibrillation Trial

OBJECTIVES: To evaluate the characteristics of volunteers responding to emergencies in the North American Public Access Defibrillation (PAD) Trial. METHODS: The PAD Trial was a prospective evaluation of cardiac arrest survival in community facilities randomized to cardiopulmonary resuscitation (CPR) or to CPR with automated external defibrillators (AEDs). The PAD volunteers' characteristics were analyzed using Poisson regression clustered on the facility and offset by the number of emergency episodes to which volunteers were exposed. RESULTS: A total of 19,320 volunteers in 1260 facilities were trained to provide emergency care. Of these, 8169 volunteers were participating actively at their facility during a time when one or more emergency episodes occurred. There were 1971 emergency episodes responded to by 1245 volunteers. The treatment arm (CPR-only versus CPR+AED) was not associated with the likelihood of volunteer participation in an episode. Likewise, the volunteers' age or sex did not affect response. Volunteers more likely to respond were supervisory/management or security personnel, non-minority participants, volunteers with previous CPR training, volunteers with previous experience in emergency care and those who passed the PAD CPR skills follow-up test. Volunteers who had a formal education beyond a high school level were less likely to respond. CONCLUSIONS: Volunteers with previous emergency training and positions of responsibility in their facility had a greater likelihood of participation in medical emergencies in the PAD Trial.     

The Age of Blood Evaluation (ABLE) randomized controlled trial: study design

Red blood cells (RBCs) are transfused to treat anemia and to maintain oxygen delivery to vital organs during critical illness. Laboratory and observational studies have raised the possibility that prolonged RBC storage may adversely affect clinical outcomes. Compared with RBCs stored less than 1 week, there are no clinical data demonstrating that RBCs stored longer remain as effective at carrying or releasing oxygen, and observational studies have risen to possibility that prolonged RBC storage might result in harm to vulnerable patients requiring blood transfusions. The "Age of Blood Evaluation" (ABLE) study (ISRCTN44878718) is a double-blind, multicenter, parallel randomized controlled clinical trial. It will test the hypothesis that the transfusion of prestorage leukoreduced RBCs stored for 7 days or less (fresh arm) as compared with standard-issue RBCs stored, on average, 15 to 20 days (control arm) will lead to lower 90-day all-cause mortality and reduced morbidity in critically ill adults. We include adults in intensive care units (ICUs) who (1) have had a request for a first RBC unit transfusion during the first 7 days of ICU admission and (2) have an anticipated requirement for ongoing invasive and noninvasive mechanical ventilation exceeding 48 hours. Enrolled patients are randomized at the time of transfusion to receive either standard-issue RBC units or RBCs stored 7 days or less issued by the local hospital transfusion service. The primary outcome is 90-day all-cause mortality. Secondary outcomes include ICU and hospital mortality, organ failure, and serious nosocomial infections. With 2510 patients, we will be able to detect a 5% absolute risk reduction (from 25% to 20%). The ABLE study is currently enrolling patients in 23 university-affiliated and community-hospital ICUs across Canada; sites in France and United Kingdom are expected to start recruitment in 2011. Regardless of the results, ABLE study will have significant implications on the duration of RBC storage. A negative trial will reassure clinicians and blood bankers regarding the effectiveness and safety of standard-issue RBCs. A positive trial will have significant implications with respect to inventory management of RBCs given to critically ill adults with a high risk of mortality and will also prompt research to better understand the RBC storage lesion in the hopes of minimizing its clinical consequences through the development of better storage methods.     

Performance of chest compressions by laypersons during the Public Access Defibrillation Trial

Background

Increasing evidence indicates that health professionals often may not achieve guideline standards for cardiopulmonary resuscitation (CPR). Little is known about layperson CPR performance.

Methods

The investigation was a retrospective cohort study of cardiac arrest patients treated by layperson CPR and one model of automated external defibrillator (AED) as part of the Public Access Defibrillation Trial (n = 26). CPR was measured using software that integrates the event log, ECG signal, and thoracic impedance signal. We assessed chest compression fraction (proportion of attempted resuscitation spent performing chest compressions), prompted compression fraction (proportion of attempted resuscitation spent performing compressions during AED-prompted periods), compression rate, and compressions per minute.

Results

Of the 26 cases, 13 presented with ventricular fibrillation and 13 with nonshockable rhythms. Overall, during the period when patients did not have spontaneous circulation, the median chest compression fraction was 34% (IQR 17-48%), median prompted chest compression fraction was 49% (IQR 30-66%), and the median chest compression rate was 96/min (IQR 90-110/min). Taken together, the median chest compression delivered per minute among all arrests was 29 (IQR 20-42). CPR characteristics differed according to initial rhythm: median chest compression per minute was 20 (IQR 13-29) among ventricular fibrillation and 42 (IQR 28-47) among nonshockable rhythms (p = 0.003).

Conclusions

In this study of trained laypersons, CPR varied substantially and often did not achieve guideline parameters. The findings suggest a need to improve CPR training, consider changes to CPR protocols, and/or improve the AED-rescuer interface.     

The effect of time on CPR and automated external defibrillator skills in the Public Access Defibrillation Trial

BACKGROUND: The time to skill deterioration between primary training/retraining and further retraining in cardiopulmonary resuscitation (CPR) and automated external defibrillation (AED) for lay-persons is unclear. The Public Access Defibrillation (PAD) trial was a multi-center randomized controlled trial evaluating survival after CPR-only versus CPR+AED delivered by onsite non-medical volunteer responders in out-of-hospital cardiac arrest. AIMS: This sub-study evaluated the relationship of time between primary training/retraining and further retraining on volunteer performance during pretest AED and CPR skill evaluation. METHODS: Volunteers at 1260 facilities in 24 North American regions underwent training/retraining according to facility randomization, which included an initial session and a refresher session at approximately 6 months. Before the next retraining, a CPR and AED skill test was completed for 2729 volunteers. Primary outcome for the study was assessment of global competence of CPR or AED performance (adequate versus not adequate) using chi(2)-test for trends by time interval (3, 6, 9, and 12 months). Confirmatory (GEE) logistic regression analysis, adjusted for site and potential confounders was done. RESULTS: The proportion of volunteers judged to be competent did not diminish by interval (3, 6, 9, and 12 months) for either CPR or AED skills. After adjusting for site and potential confounders, longer intervals to further retraining was associated with a slightly lower likelihood of performing adequate CPR but not with AED scores. CONCLUSIONS: After primary training/retraining, the CPR skills of targeted lay responders deteriorate nominally but 80% remain competent up to 1 year. AED skills do not deteriorate significantly and 90% of volunteers remain competent up to 1 year.     

Physical activity across the curriculum (PAAC): rationale and design

BACKGROUND: Over the years schools have reduced physical education and recess time in favor of more academic instruction. Due to the drastic rise in obesity levels among children, some states have begun to mandate minimum amounts of physical activity (PA) that school children receive, causing schools to find alternative methods for increasing PA levels. Physical Activity Across the Curriculum (PAAC) is a 3-year randomized clinical trial incorporating moderate-intensity PA in elementary schools to reduce childhood obesity. This paper describes the rational, design, and methods of the PAAC intervention study. METHODS: Twenty-two elementary schools were randomized to either a control or intervention condition. In schools randomized to the intervention condition (PAAC), regular classroom teachers were taught how to incorporate PA into standard academic lessons. Teachers were asked to accumulate 90-100 min/week of PAAC each week through out the 3-year study period. Schools randomized to the control group did not alter their teaching methods. Direct observation of PA levels in the classroom was collected weekly. Height and weight was measured twice a year to calculate BMI. RESULTS: Two years of the intervention have been completed and only one school has left the study. The remaining 21 schools are participating in the final intervention year. CONCLUSIONS: The results from the PAAC intervention may provide schools with an alternative method to increase PA levels in children and reduce childhood obesity.