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Biomedical subjects

Michael R Sayre

Publications and source records attributed to Michael R Sayre.

At least 19 recordsLinked to original sources
PubMed2006

Manual chest compression vs use of an automated chest compression device during resuscitation following out-of-hospital cardiac arrest: a randomized trial.

CONTEXT: High-quality cardiopulmonary resuscitation (CPR) may improve both cardiac and brain resuscitation following cardiac arrest. Compared with manual chest compression, an automated load-distributing band (LDB) chest compression device produces greater blood flow to vital organs and may improve resuscitation outcomes. OBJECTIVE: To compare resuscitation outcomes following out-of-hospital cardiac arrest when an automated LDB-CPR device was added to standard emergency medical services (EMS) care with manual CPR. DESIGN, SETTING, AND PATIENTS: Multicenter, randomized trial of patients experiencing out-of-hospital cardiac arrest in the United States and Canada. The a priori primary population was patients with cardiac arrest that was presumed to be of cardiac origin and that had occurred prior to the arrival of EMS personnel. Initial study enrollment varied by site, ranging from late July to mid November 2004; all sites halted study enrollment on March 31, 2005. INTERVENTION: Standard EMS care for cardiac arrest with an LDB-CPR device (n = 554) or manual CPR (n = 517). MAIN OUTCOME MEASURES: The primary end point was survival to 4 hours after the 911 call. Secondary end points were survival to hospital discharge and neurological status among survivors. RESULTS: Following the first planned interim monitoring conducted by an independent data and safety monitoring board, study enrollment was terminated. No difference existed in the primary end point of survival to 4 hours between the manual CPR group and the LDB-CPR group overall (N = 1071; 29.5% vs 28.5%; P = .74) or among the primary study population (n = 767; 24.7% vs 26.4%, respectively; P = .62). However, among the primary population, survival to hospital discharge was 9.9% in the manual CPR group and 5.8% in the LDB-CPR group (P = .06, adjusted for covariates and clustering). A cerebral performance category of 1 or 2 at hospital discharge was recorded in 7.5% of patients in the manual CPR group and in 3.1% of the LDB-CPR group (P = .006). CONCLUSIONS: Use of an automated LDB-CPR device as implemented in this study was associated with worse neurological outcomes and a trend toward worse survival than manual CPR. Device design or implementation strategies require further evaluation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00120965.

Aged↗
PubMed2005

Providing automated external defibrillators to urban police officers in addition to a fire department rapid defibrillation program is not effective.

OBJECTIVE: The aim of this study was to determine if providing automated external defibrillators (AEDs) to urban police officers would increase the proportion of patients with out-of-hospital cardiac arrest (OOH-CA) who were discharged alive from the hospital. METHODS: This prospective, controlled study was conducted in a city with about 332,000 persons. The EMS system included paramedic ambulances and fire department based first responders equipped with defibrillators, but police officers did not respond routinely to medical emergencies. Between March 1997 and February 1999, all OOH-CAs in four police districts were identified and followed until death or hospital discharge. All 35 police cars in one police district were provided with AEDs, and all police officers in that district were trained in CPR and the use of AEDs. Police and fire first response units were dispatched simultaneously in district 3 (intervention group). Fire first response was dispatched without police in districts 2, 4, and 5 (control group). RESULTS: A total of 645 OOH-CAs occurred over the 2 years. Sixty-two were outside of the study area. Two did not have accurate address information to determine the police district. Of the remaining cases, 154 (27%) occurred in the intervention district and 427 (73%) were in the control area. Survival to hospital discharge was similar; it was 11/154 (7.1%) in the intervention and 16/427 (3.8%) in the control districts (odds ratio=1.98; 95% CI 0.90--4.36). Survival to hospital discharge for witnessed OOH-CA events occurring prior to EMS arrival and found to be in ventricular fibrillation or ventricular tachycardia was 4/27 (15%) in the intervention area and 9/73 (12%) in the control area (odds ratio=1.2; 95% CI 0.4-4.4). CONCLUSION: Equipping police cars with AEDs in an urban area where the fire department-based first response system also carries defibrillators did not improve the hospital discharge survival rate for victims of OOH-CA.

Automation↗
PubMed2005

Research conditions that qualify for emergency exception from informed consent.

Medical research involving critically ill and injured subjects unable to provide informed consent can only be conducted under federal regulations that attempt to balance the need to develop lifesaving treatments with protection of research subjects' rights. Regulators, researchers, and medical ethicists have all struggled to define the conditions under which an emergency exception from informed consent is appropriate. Although research has been successfully conducted under the current regulations, confusion remains regarding the meaning of the regulations, the applicable conditions, and the best ways to balance the needs of future patients and the rights of research subjects. In May 2005, at the Academic Emergency Medicine Consensus Conference "Ethical Conduct of Resuscitation Research," a breakout session was held on the research conditions that qualify for the emergency exception from informed consent process. Several recommendations emerged: 1) The definition of "life-threatening condition" should be broadly interpreted to include serious disability as well as death. 2) Existing therapies should be considered "unsatisfactory," even if partially effective, when serious risk of morbidity or mortality remains even with the best available treatment or when the adverse effects of the best available treatment are serious. 3) Research with the emergency exception should be performed only if sufficient evidence exists that the proposed intervention has a reasonable chance of benefit. 4) More evaluation is needed to determine the degree to which the current rules impede research. 5) Application of the current regulatory framework for abbreviated or waived consent in emergency research should be encouraged. 6) Further study should also address variability among institutional review boards, the goals of community involvement, and how best to engage and educate the public in research efforts using emergency exception from informed consent.

Community-Institutional Relations↗
PubMed2004

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.

Cardiopulmonary Resuscitation↗
PubMed2004

Measuring survival rates from sudden cardiac arrest: the elusive definition.

BACKGROUND: Measuring survival from sudden out-of-hospital cardiac arrest (OOH-CA) is often used as a benchmark of the quality of a community's emergency medical service (EMS) system. The definition of OOH-CA survival rates depends both upon the numerator (surviving cases) and the denominator (all cases). PURPOSE: The purpose of the public access defibrillation (PAD) trial was to measure the impact on survival of adding an automated external defibrillator (AED) to a volunteer response system trained in CPR. This paper reports the definition of OOH-CA developed by the PAD trial investigators, and it evaluates alternative statistical methods used to assess differences in reported "survival." METHODS: Case surveillance was limited to the prospectively determined geographic boundaries of the participating trial units. The numerator in calculating a survival rate should include only those patients who survived an event but who otherwise would have died except for the application of some facet of emergency medical care-in this trial a defibrillatory shock. Among denominators considered were: total population of the study unit, all deaths within the study unit, and documented ventricular fibrillation cardiac arrests. The PAD classification focused upon cases that might have benefited from the early use of an AED, in addition to the likely benefit from early recognition of OOH-CA, early access of EMS, and early cardiopulmonary resuscitation (CPR). Results of this classification system were used to evaluate the impact of the PAD definition on the distribution of cardiac arrest case types between CPR only and CPR + AED units. RESULTS: Potential OOH-CA episodes were classified into one of four groups: definite, probable, uncertain, or not an OOH-CA. About half of cardiac arrests in the PAD units were judged to be definite OOH-CA events and therefore potentially treatable with an AED. However, events that occurred in CPR-only units were less likely to be classified as definite or probable OOH-CA events than those in CPR + AED units (43% versus 55%, odds ratio 0.78, 95% confidence interval 0.57-1.07). The study retained sufficient power to permit a statistical analysis of the alternative hypothesis that the CPR + AED method results in twice as many survivors as a CPR-only approach. The result is critically dependent on the denominator used for calculating survival rates; but the analysis does not require a denominator as the numerators will have identical Poisson distributions (counts for rare events) under the null hypothesis since randomization distributes the risk of cardiac arrest evenly between the two arms. CONCLUSION: Reported OOH-CA rates and survival rates vary widely, depending upon the definitions applied to events. Rigorous assessment of treatments applied to improve survival can be obscured by inappropriate definitions. Large-scale randomized interventions designed to improve survival from OOH-CA can be evaluated based upon the absolute numbers of patients surviving, rather than a change in the proportion surviving.

Cardiopulmonary Resuscitation↗
PubMed2003

2-D echocardiography prediction of adverse events in ED patients with chest pain.

The objective of this study was to establish the efficacy of two-dimensional (2-D) echocardiography (echo) in predicting adverse cardiac events in patients presenting to the ED with possible acute coronary syndrome (ACS). Patients 25 years of age or older having symptoms consistent with ACS and a non-diagnostic electrocardiogram (ECG) were evaluated with 0-, 3-, 6-, and 9-hour creatine kinase -MB (CK-MB) assays and continuous 12-lead ECG ST-segment monitoring. Patients with normal serial CK-MB assays and no ECG changes after 9 hours had a resting 2-D transthoracic echo performed. A positive 2-D echo was defined as segmental or global wall motion abnormalities. Patients were followed up after 6 months to identify adverse events resulting from ACS. Of the 1112 patients receiving an echo, 18 had positive studies. None had adverse events on follow-up. Of the 1094 patients with a negative 2-D echo, 15 had adverse events (2 acute myocardial infarctions, 2 coronary artery bypass graftings, and 11 percutaneous transluminal coronary angioplasties). Resting 2-D echo did not predict cardiac adverse events in patients with possible ACS and non-diagnostic serial 12-lead ECG and normal serial CK-MB at the end of a 9-hour evaluation.

Acute Disease↗
PubMed2003

National EMS research agenda: proceedings of the implementation symposium.

The National EMS Research Agenda identified eight recommendations for improving the conduct of emergency medical services (EMS) research in the United States. EMS leaders from across the country attended a two-day symposium to discuss implementation of the Research Agenda recommendations. The participants suggested specific methods to move the recommendations forward. These included improving training opportunities for EMS researchers, stimulating increases in available funding sources, facilitating the integration of research into practice, and crafting alterations within the regulatory environment. Participants felt that EMS must be more broadly integrated into the public health continuum. Federal agencies, states, local governments, charitable foundations, and corporations are asked to examine their practices to increase opportunities for participation in EMS research programs at all stages of the process.

Emergency Medical Services↗
PubMed2002

Damage control: past, present, and future of prehospital stroke management.

Early identification of stroke patients by emergency medical services is a valuable part of optimal care. Accurate identification of the stroke victim by EMS has been shown to expedite treatment. Care is enhanced when the EMS professional ascertains when the patient was last at baseline state, performs an expeditious assessment and transport, checks the patient's blood glucose level, and avoids lowering the blood pressure. The death and disability toll of acute stroke can be lowered. There is a long way to go, however. EMS professionals can help make progress on that journey.

Ambulances↗
PubMedDate not supplied

Mathematical determination of external defibrillators needed at mass gatherings.

OBJECTIVE: To develop a mathematical formula that assists in determining the number of automated external defibrillators (AEDs) needed at sites of mass gatherings. METHODS: Twenty (10 male, 10 female) healthy volunteers (equally divided between age groups 21-30 and 31-40 years) responded to mock cardiac arrests in a sports stadium. Seven different first-responder scenarios were simulated (ascending and descending three separate stairway slopes (22 degrees, 39 degrees, and 69 degrees ), as well as a response across a horizontal (0 degrees ) surface. To assess the impact of spectator congestion, the same volunteers conducted each scenario in an empty and full stadium. The quantitative relationship between time and distance was then plotted for each situation. Using the quantitative relationship, the area a first responder can cover in a specified time was calculated. RESULTS: The formula for the total number of AEDs needed in a stadium (or other mass gathering site) can be expressed as follows: Total AEDs=[A(1)/(Ds(1)xDh(1))]+[A(2)/(Ds(2)xDh(2))]+[A(3)/(Ds(3)xDh(3))] where A(1), A(2), and A(3) represent the total areas of a stadium with a slight, moderate, or steep stairway slope, respectively; Ds(1), Ds(2), and Ds(3) represent the stairway distance a first responder must ascend or descend for each slope; and Dh(1), Dh(2), and Dh(3) are the horizontal distances a responder can run in the time remaining. CONCLUSION: Given a medical director's targeted response times and goals, the optimal number of AEDs required at a mass gathering can be calculated using time versus distance relationships. Future studies should evaluate the impact of the mathematically derived optimal number of AEDs at mass gatherings.

Adult↗
PubMedDate not supplied

Law Enforcement Agency Defibrillation (LEA-D): proceedings of the National Center for Early Defibrillation Police AED Issues Forum.

Why does LEA-D intervention seem to work in some systems but not others? Panelists agreed that some factors that delay rapid access to treatment, such as long travel distances in rural areas, may represent insurmountable barriers. Other factors, however, may be addressed more readily. These include: absence of a medical response culture, discomfort with the role of medical intervention, insecurity with the use of medical devices, a lack of proactive medical direction, infrequent refresher training, and dependence on EMS intervention. Panelists agreed that successful LEA-D programs possess ten key attributes (Table 6). In the end, the goal remains "early" defibrillation, not "police" defibrillation. It does not matter whether the rescuer wears a blue uniform--or any uniform, for that matter--so long as the defibrillator reaches the victim quickly. If LEA personnel routinely arrive at medical emergencies after other emergency responders or after 8 minutes have elapsed from the time of collapse, an LEA-D program will be unlikely to provide added value. Similarly, if police frequently arrive first, but the department is unwilling or unable to cultivate the attributes of successful LEA-D programs, efforts to improve survival may not be realized. In most communities, however, LEA-D programs have tremendous lifesaving potential and are well worth the investment of time and resources. Law enforcement agencies considering adoption of AED programs should review the frequency with which police arrive first at medical emergencies and LEA response intervals to determine whether AED programs might help improve survival in their communities. It is time for law enforcement agency defibrillation to become the rule, not the exception.

Cardiopulmonary Resuscitation↗
PubMedDate not supplied

Eliminating errors in emergency medical services: realities and recommendations.

Errors in health care can have serious consequences, not only for patients but for society as a whole, given the considerable national expenditures required to address these errors. Because of the number of patients treated and the acuity of emergency situations, eliminating errors should be a priority in emergency medical services (EMS) systems. In a recent report, the Institute of Medicine called for improvements in patient safety, which it defined as freedom from accidental injury. Recent efforts have focused on integrating EMS systems into error analyses of the total health care system. However, EMS systems must take the initiative in addressing their own major error-prone areas using the best and most current data available. Unfortunately, addressing the problem of medical errors in EMS systems still suffers from a paucity of data, owing to a lack of organized, funded programs backed by legislation and dedicated government coordination. We recommend that EMS medical directors consider specific error audits to decrease sources of errors and to be better able to identify EMS providers who would benefit from retraining. Error audits might first be focused on the following potentially serious errors: equipment malfunction, failure to check oxygen saturation, failure to immobilize the patient, use of incorrect protocol or algorithm, failure to check glucose levels, failure to recognize patient deterioration, failure to detect misplaced endotracheal tubes, and use of wrong drug or drug dose.

Emergency Medical Services↗
PubMedDate not supplied

Current issues in cardiopulmonary resuscitation.

Current Advanced Cardiac Life Support (ACLS) guidelines and emergency medical services (EMS) clinical protocols usually recommend immediate defibrillation for victims of out-of-hospital cardiac arrest who have ventricular fibrillation (VF). However, animal studies and results from a small number of clinical investigations now suggest that a short period of chest compressions or ACLS procedures delivered before defibrillation may improve the outcome of patients with prolonged VF. Although the basic science and clinical data supporting a chest-compression-first procedure are compelling, large, multicenter randomized trials are still necessary to determine whether such protocols do indeed improve outcome. In current EMS dispatch practice, traditional cardiopulmonary resuscitation (CPR) instructions are given when needed to bystanders who report a possible cardiac arrest. Recent literature has shown that in certain circumstances, CPR instructions involving chest compressions alone may be given more quickly and can yield an equivalent, if not better, chance of survival. Although this practice is controversial, the general consensus is that any CPR is better than none at all. Therefore, telephone CPR protocols that recommend the immediate initiation of chest compressions may be preferred, particularly for callers who have no previous training in CPR.

Advanced Cardiac Life Support↗
PubMedDate not supplied

The National EMS Research strategic plan.

One of the eight major recommendations put forth by the National EMS Research Agenda Implementation Project in 2002 was the development of an emergency medical services (EMS) research strategic plan. Using a modified Delphi technique along with a consensus conference approach, a strategic plan for EMS research was created. The plan includes recommendations for concentrating efforts by EMS researchers, policy makers, and funding resources with the ultimate goal of improving clinical outcomes. Clinical issues targeted for additional research efforts include evaluation and treatment of patients with asthma, acute cardiac ischemia, circulatory shock, major injury, pain, acute stroke, and traumatic brain injury. The plan calls for developing, evaluating, and validating improved measurement tools and techniques. Additional research to improve the education of EMS personnel as well as system design and operation is also suggested. Implementation of the EMS research strategic plan will improve both the delivery of services and the care of individuals who access the emergency medical system.

Emergency Medical Services↗