Effect of nesiritide in patients with acute decompensated heart failure.

BACKGROUND: Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. METHODS: We randomly assigned 7141 patients who were hospitalized with acute heart failure to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care. Coprimary end points were the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, and the composite end point of rehospitalization for heart failure or death within 30 days. RESULTS: Patients randomly assigned to nesiritide, as compared with those assigned to placebo, more frequently reported markedly or moderately improved dyspnea at 6 hours (44.5% vs. 42.1%, P=0.03) and 24 hours (68.2% vs. 66.1%, P=0.007), but the prespecified level for significance (P≤0.005 for both assessments or P≤0.0025 for either) was not met. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group (absolute difference, -0.7 percentage points; 95% confidence interval [CI], -2.1 to 0.7; P=0.31). There were no significant differences in rates of death from any cause at 30 days (3.6% with nesiritide vs. 4.0% with placebo; absolute difference, -0.4 percentage points; 95% CI, -1.3 to 0.5) or rates of worsening renal function, defined by more than a 25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds ratio, 1.09; 95% CI, 0.98 to 1.21; P=0.11). CONCLUSIONS: Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.).

The effect of post-injury depression on return to pre-injury function: a prospective cohort study.

BACKGROUND: Millions of people seek emergency department (ED) care for injuries each year, the majority for minor injuries. Little is known about the effect of psychiatric co-morbid disorders that emerge after minor injury on functional recovery. This study examined the effect of post-injury depression on return to pre-injury levels of function. METHOD: This was a longitudinal cohort study with follow-up at 3, 6 and 12 months post-injury: 275 adults were randomly selected from those presenting to the ED with minor injury; 248 were retained over the post-injury year. Function was measured with the Functional Status Questionnaire (FSQ). Psychiatric disorders were diagnosed using the Structured Clinical Interview for DSM-IV-TR disorders (SCID). RESULTS: During the post-injury year, 18.1% [95% confidence interval (CI) 13.3-22.9] were diagnosed with depression. Adjusting for clinical and demographic covariates, the depressed group was less likely to return to pre-injury levels of activities of daily living [odds ratio (OR) 8.37, 95% CI 3.78-18.53] and instrumental activities of daily living (OR 3.25, 95% CI 1.44-7.31), less likely to return to pre-injury work status (OR 2.37, 95% CI 1.04-5.38), and more likely to spend days in bed because of health (OR 2.41, 95% CI 1.15-5.07). CONCLUSIONS: Depression was the most frequent psychiatric diagnosis in the year after minor injury requiring emergency care. Individuals with depression did not return to pre-injury levels of function during the post-injury year.

Initial risk stratification and presenting characteristics of patients with evolving myocardial infarctions.

OBJECTIVES: To describe the presenting characteristics and risk stratification of patients presenting to the emergency department with chest pain who have a normal initial troponin level followed by a raised troponin level within 12 h (evolving myocardial infarction (EMI)). METHODS: Data from the Internet Tracking Registry for Acute Coronary Syndromes (i*trACS), a registry of patients presenting with undifferentiated chest pain, were used. This analysis included patients without ST segment elevation with at least two troponin assay results < or = 12 h apart. Patients were stratified into three groups: EMI (initial troponin assay negative, second troponin assay positive), non-ST elevation myocardial infarction (NSTEMI) (initial troponin assay positive) and no MI (all troponin assays negative). RESULTS: Of 4136 eligible patients, 5% had EMI, 8% had NSTEMI and 87% had no MI. Patients with EMI were more similar to those with NSTEMI than those with no MI with respect to demographic characteristics, presentation, admission patterns and revascularisation. The initial ECG in patients with EMI was most commonly non-diagnostic (51%), but physicians' initial impressions commonly reflected MI, unstable angina or high-risk chest pain (76%). This risk assessment was followed by a high rate of critical care admissions (32%) and revascularisation (percutaneous coronary intervention 17%) among patients with EMI. CONCLUSION: Patients with EMI appear similar at presentation to those with NSTEMI. Patients with EMI are perceived as being at high risk, evidenced by similar diagnostic impressions, admission practices and revascularisation rates to patients with NSTEMI.

Morphine and outcomes in acute decompensated heart failure: an ADHERE analysis.

OBJECTIVE: Morphine is a long-standing therapy in acute decompensated heart failure (ADHF), despite few supporting data. A study was undertaken to compare the outcomes of patients who did and did not receive morphine for ADHF. METHODS: The study was a retrospective analysis of the Acute Decompensated Heart Failure National Registry (ADHERE) which enrols hospitalised patients with treatment for, or a primary discharge diagnosis of, ADHF. Patients were stratified into cohorts based on whether or not they received intravenous morphine. ANOVA, Wilcoxon and chi(2) tests were used in univariate analysis, followed by multivariate analysis controlling for parameters previously associated with mortality. Analyses were repeated for ejection fraction subgroups and in patients not on mechanical ventilation. RESULTS: There were 147 362 hospitalisations in ADHERE at December 2004, 20 782 of whom (14.1%) received morphine and 126 580 (85.9%) did not. There were no clinically relevant differences between the groups in the initial age, heart rate, blood pressure, blood urea nitrogen, creatinine, haemoglobin, ejection fraction or atrial fibrillation. A higher prevalence of rest dyspnoea, congestion on chest radiography, rales and raised troponin occurred in the morphine group. Patients on morphine received more inotropes and vasodilators, were more likely to require mechanical ventilation (15.4% vs 2.8%), had a longer median hospitalisation (5.6 vs 4.2 days), more ICU admissions (38.7% vs 14.4%), and had greater mortality (13.0% vs 2.4%) (all p<0.001). Even after risk adjustment and exclusion of ventilated patients, morphine was an independent predictor of mortality (OR 4.84 (95% CI 4.52 to 5.18), p<0.001). CONCLUSIONS: Morphine is associated with increased adverse events in ADHF which includes a greater frequency of mechanical ventilation, prolonged hospitalisation, more ICU admissions and higher mortality.

The effect of written informed consent on detection of violence in the home.

UNLABELLED: Studies of programmatic interventions for victims of violence in the home may require the use of informed consent. The use of informed consent may result in ascertainment bias, with victims of violence being less likely to participate. OBJECTIVE: To investigate the effect of written informed consent on the detection of violence in the home during emergency department (ED) screening. METHODS: The authors performed a nonrandomized, controlled trial of 3,466 patients at an urban university ED. On odd days, patients (n = 1,857) were read a brief scripted statement and screened using standardized questions. On even days, patients (n = 1,609) received standard written informed consent prior to the same screening questions (writ-IC). The main outcome was the number of cases of violence in the home detected using each screening protocol. RESULTS: Fewer writ-IC patients participated in screening (82% vs 92%; p < 0.001). Despite a higher refusal rate in the writ-IC group, there was no difference in the number of victims detected by each screening method: choked/kicked/bit/punched? (writ-IC, 7.3 vs routine screen, 6.5%; p = 0.3); slapped/grabbed/shoved? (7.3 vs 6.7%; p = 0.4); threatened/actually used knife/gun to scare/hurt you? (8.3 vs 9.4%; p = 0.3); thrown object to harm you? (5.2 vs 4.6%; p = 0.4); forced sex? (5.8 vs 4.7%; p = 0.15); or afraid current/former intimate partner would hurt you physically? (13.9 vs 11.9%; p = 0.9). CONCLUSIONS: A written informed consent process in screening for violence in the home is associated with a higher refusal rate than routine screening, but use of written informed consent does not result in a lower rate of detection for multiple forms of violence. The authors did not find any support for the hypothesis that the use of written informed consent would decrease detection of violence in the home.

Combination of Goldman risk and initial cardiac troponin I for emergency department chest pain patient risk stratification.

BACKGROUND: Accurate identification of low-risk emergency department (ED) chest pain patients who may be safe for discharge has not been well defined. Goldman criteria have reliably risk-stratified patients but have not identified any subset safe for ED release. Cardiac troponin I (cTnI) values have also been shown to risk-stratify patients but have not identified a subset safe for ED release. OBJECTIVE: To test the hypothesis that ED chest pain patients with a Goldman risk of < or =4% and a single negative cTnI (< or =0.3 ng/mL) at the time of ED presentation would be safe for discharge [<1% risk for death, acute myocardial infarction (AMI), revascularization]. METHODS: A prospective cohort study was performed in which consecutive ED chest pain patients were enrolled from July 1999 to November 2000. Data collected included patient demographics, medical and cardiac history, electrocardiogram, and creatine kinase-MB and cTnI. Goldman risk stratification score was calculated while patients were still in the ED. Hospital course was followed daily. Telephone follow-up occurred at 30 days. The main outcome was death, AMI, or revascularization (percutaneous transluminal coronary angioplasty/stents/coronary artery bypass grafting) within 30 days. RESULTS: Of 2,322 patients evaluated, 998 had both a Goldman risk < or =4% and a cTnI < or =0.3 ng/mL. During the initial hospitalization, 37 patients met the composite endpoint (3.7%): 6 deaths (0.7%), 17 AMIs (1.7%), 18 revascularizations (1.8%). Between the time of hospital discharge and 30-day follow-up, 15 patients met the composite endpoint: 4 deaths (0.4%), 6 AMIs (0.6%), and 5 revascularizations (0.5%). Overall, 49 patients met the composite endpoint (4.9%; 95% CI = 3.6% to 6.2%): 10 deaths (1.0%; 95% CI = 0.4% to 1.6%); 23 AMIs (2.3%; 95% CI = 1.4% to 3.2%), and 23 revascularizations (2.3%; 95% CI = 1.4% to 3.2%) within 30 days of presentation. CONCLUSIONS: The combination of two risk stratification modalities for ED chest pain patients (Goldman risk < or =4% and cTnI < or =0.3 ng/mL) did not identify a subgroup of chest pain patients at <1% risk for death, AMI, or revascularization within 30 days.

Characteristics and outcomes of young adults who present to the emergency department with chest pain.

BACKGROUND: Most studies of emergency department (ED) chest pain patients exclude patients <30-40 years old. As a result, the clinical course of these patients is poorly described. OBJECTIVE: To study the clinical characteristics, hospital course, and 30-day outcomes of ED chest pain patients <40 years old. The hypothesis was that patients <40 years old without a cardiac history and with normal electro-cardiograms (ECGs) or no cardiac risk factors would be at a <1% risk for acute coronary syndromes (ACSs) and 30-day adverse cardiovascular (CV) events. METHODS: This was a prospective cohort study of non-cocaine-using ED patients, 24-39 years old, who received an ECG for chest pain between July 9, 1999, and October 23, 2000. Structured data collection at presentation included demographics, chest pain description, history, laboratory, and ECG data. Hospital course was followed daily. Thirty-day follow-up was performed by telephone. The main outcomes were discharge diagnosis and 30-day adverse CV events [acute myocardial infarction (AMI), death, percutaneous intervention (PCI), or coronary artery bypass grafting (CABG)]. RESULTS: A total of 487 patients presented 527 times and comprised the study group. Patients were most often 30-39 years old (71%), female (60%), and African-American (73%). Thirty-two percent were admitted. Five hundred seven of 527 patient visits (96%) had 30-day follow-up. Patients had the following cardiac risk factors: tobacco, 37%; hypertension, 22%; family history, 19%; diabetes mellitus, 6%; cholesterol, 6%; prior angina, 3%; known coronary artery disease, 3%; and prior AMI, 2%. Patients usually had unremarkable ECGs (61% normal, 98% nonischemic). Overall, 11 of 527 patients had adverse CV events (2.1%; 95% CI = 0.9% to 3.3%): 8 AMIs (1.5%), 4 deaths (0.8%), 5 PCIs (0.9%), and no CABG. Twenty-five patients had a final diagnosis of ACS (4.7%; 95% CI = 2.9% to 6.5%). The incidence of ACS in the 210 patients without a cardiac history and without cardiac risk factors was 0.5% (95% CI = 0% to 1.4%). At 30 days, none of these 210 patients had AMI, PCI, CABG, or death (0%, 95% CI = 0% to 1.4%). The incidence of ACS in the 312 patients with normal ECGs and a negative cardiac history was 0.3% (95% CI = 0% to 0.9%). At 30 days, there was no AMI, PCI, or CABG in these 312 patients, and one patient with metastatic cancer died (adverse CV event 0.3%, 95% CI = 0% to 0.9%). CONCLUSIONS: Although young patients, as a whole, have a 4.7% risk of ACSs and a 2.1% risk of adverse CV events at 30 days, those without known cardiac disease or any cardiac risk factors had a <1% risk of ACSs and were free from adverse CV events over 30 days. Likewise, young patients without a cardiac history and with a normal ECG had a <1% risk of ACSs and adverse CV events at 30 days. It may be reasonable to expedite outpatient management and limit unnecessary admissions in these cohorts.

Risk factors for infection in patients with traumatic lacerations.

BACKGROUND: Most of our knowledge of laceration management comes from studies in animal models or patients with closure of sterile postoperative surgical incisions. Traumatic laceration management has not been well studied. OBJECTIVE: To determine which characteristics of traumatic lacerations were associated with the development of wound infection. METHODS: A cross-sectional study of consecutive patients with traumatic lacerations repaired over a four-year period was conducted. Structured closed-question data sheets were prospectively completed at the time of laceration repair and suture removal. Infection was determined at the time of suture removal. Multivariate modeling was used to determine the adjusted odds ratio (OR) of infection. RESULTS: Five thousand five hundred twenty-one patients were enrolled; 195 patients developed an infection (3.5%). An increased likelihood of wound infection was associated with age (adjusted OR per year, 1.01; 95% CI = 1.0 to 1.02); history of diabetes mellitus (adjusted OR 6.7; 95% CI = 1.7 to 26.4); laceration width (adjusted OR 1.05 per mm; 95% CI = 1.02 to 1.08); and presence of foreign body (adjusted OR 2.6; 95% CI = 1.3 to 5.2). Laceration location on the head/neck was associated with a decreased risk of infection (adjusted OR 0.28; 95% CI = 0.18 to 0.45). CONCLUSIONS: Both patient and wound characteristics of traumatic lacerations have an influence on the likelihood of infection. This knowledge may be valuable for determining whether various methods of wound cleansing, debridement, and repair can improve the outcome of patients with traumatic lacerations.

A randomized, controlled trial of a simple emergency department intervention to improve the rate of primary care follow-up for patients with acute asthma exacerbations.

STUDY OBJECTIVE: We determined whether a simple emergency department intervention improves the likelihood of primary care provider (PCP) follow-up after ED discharge for an acute asthma exacerbation. METHODS: This randomized, controlled clinical trial was conducted in an urban university-based ED. Participants were patients with asthma between the ages of 16 and 45 years who were treated and discharged from the ED. The study intervention was usual care or an intervention that consisted of a free 5-day course of prednisone, vouchers for transportation to and from their PCP, and a 48-hour telephone reminder to make an appointment with their PCP. The main outcome was whether the patient received follow-up care as determined by PCP contact at 4 weeks. RESULTS: One hundred ninety-two patients with asthma were enrolled over 8 months; 178 (93%) had complete follow-up. The intervention and control groups were similar with regard to age, sex, ethnicity, or years of education. The 2 groups were also comparable with respect to multiple measures of baseline access/barriers to care and severity of ED exacerbation. Patients receiving the intervention were significantly more likely to follow up with their PCP than control patients (relative risk 1.6; 95% confidence interval [CI] 1.1, 2.4). When adjusted for other factors influencing PCP follow-up care (ethnicity, prior PCP relationship, insurance status, regular car access), intervention patients were more likely to follow up with their PCP (odds ratio 3.1; 95% CI 1.5, 6.3). CONCLUSION: Providing medication, transportation vouchers, and a telephone reminder to make an appointment increased the likelihood that discharged patients with asthma obtained PCP follow-up.

Drug screening versus history in detection of substance use in ED psychiatric patients.

Because self-reporting of substance use may not be reliable, physicians rely on drug screening. We tested the hypothesis that drug screening alone is sufficient to detect substance use in ED psychiatric patients. We prospectively evaluated patients receiving psychiatric consultation over 6 months ending in April 1998 in an urban medical/psychiatric ED with 42,000 annual visits. After informed consent, patients underwent a structured interview by trained research associates who queried regarding substance use in the past 3 days. This self-report was compared with urine drug screen results for 11 substances of abuse. Standard descriptive statistical techniques were used. Kappa statistics were used to assess concordance between history and drug screens. Two hundred eighteen patients participated, 124 had a urine drug screen obtained. Patients with and without urine drug screens were similar with respect to age (34.9 versus 34.9 years, P =.3) and psychiatric diagnosis (P =.24). Overall, there was only fair concordance between history and drug screens (kappa = 0.46). History alone detected substance use in 70 patients (57%); drug screening alone detected substance use in 77 patients (62%). The combination of history and drug screening more often detected substance use than either alone (90 pts (73%); P <.05 for both comparisons). Depending on the particular drug, there was wide variation in concordance between history and drug screen (kappa's varied from 0.07 for ethanol to 0. 79 for cocaine). History was better than drug screening for ethanol use (40 versus 10 patients), and THC (28 versus 15 pts). Drug testing alone was never significantly better than history. Although self-reporting of substance use is not reliable, reliance on drug screening alone is also flawed. Optimal identification of drug use in emergency department psychiatric patients requires both history and drug screening.

Patient priorities with traumatic lacerations.

Clinical trials should use outcomes that are important to patients. We sought to determine the aspects of laceration management that are most important to patients. A prospective observational survey was conducted at one suburban and one urban university ED during November to December 1998 that included ED patients and visitors with and without current or prior lacerations. Trained research assistants approached 747 people of which 724 (97%) completed a 25-item closed question survey that evaluated demographics, prior laceration repairs, and assessed the relative importance of least painful repair, ED length of stay, cosmetic outcome, functional recovery, practitioner compassion, avoidance of wound infection, total costs, and missed days of work or school using a five-item Likert scale (not important-extremely important). Additionally, the relative importance of these items was compared. Data were analyzed with descriptive statistics and 95% confidence intervals (CIs). Seven hundred twenty-four people participated; 383 (53%) had prior lacerations; 92 (14%) had lacerations at the time of the survey. The most important aspect of care for respondents were normal function (28%), avoiding infection (20%), cosmetic outcome (17%), and least painful repair (17%). Based on Likert scale data, most important aspects of care were: avoiding wound infection (mean [95% CI], 4.58 [4.52 to 4.64]), normal function (4.54 [4.48 to 4.6]), cosmetic outcome (3.78 [3.68 to 3.88]), and least painful repair (3.84 [3.76 to 3.92]). Cost, length of stay, missed work/school, and compassion were less important (range, 3.0 to 3.7). Patients with facial lacerations chose cosmetic outcome as the most important aspect of care while all others chose function. Patients prioritize the medical outcomes of laceration repair (function, avoiding infection, cosmesis, pain) more than cost, compassion, ED length of stay and inconvenience (missed work/school). Cosmetic outcome is particularly important to patients with facial lacerations. This information should be useful when designing outcome studies of laceration management.

Cocaine-associated chest pain: how common is myocardial infarction?

OBJECTIVE: Prior studies addressing the incidence of acute myocardial infarction (AMI) in patients with cocaine-associated chest pain have found divergent results. Previous prospective studies, which found approximately a 6% incidence of AMI, have been criticized for selection bias. This study sought to determine the rate of AMI in patients with cocaine-associated chest pain. METHODS: All patients seen in an urban university-affiliated hospital between July 1996 and February 1998 were identified by ICD-9 medical records search for cocaine use and chest pain/ acute coronary syndromes. In this system, all faculty admit all patients with cocaine-associated chest pain for at least 23-hour observation periods. Data collected included demographics, medical and cocaine use history, presenting characteristics, hospital course, cardiovascular complications, and diagnostic tests using a 119-item closed-question data instrument with high interrater reliability. The main outcome measure was AMI according to World Health Organization (WHO) criteria. RESULTS: There were 250 patients identified with a mean age of 33.5 +/- 8.5 years; 77% were male; 84% were African American. Of 196 patients tested, 185 had cocaine or cocaine metabolites in the urine (94%). The incidence of cardiac risk factors were: hypercholesterolemia, 8%; diabetes, 6%; family history, 34%; hypertension, 26%; tobacco use, 77%; prior MI, 6%; and prior chest pain, 40%. Seventy-seven percent admitted to cocaine use in the preceding 24 hours: crack, 85%; IV, 2%; nasal, 6%. Twenty-five patients (10%) had electrocardiographic evidence of ischemia. A total of 15 patients experienced an AMI (6%; 95% CI = 4.1% to 8.9%) using WHO criteria. Complications were infrequent: bradydysrrhythmias, 0.4%; congestive heart failure, 0.4%; supraventricular tachycardia, 1.2%; sustained ventricular tachycardia, 0.8%. CONCLUSION: The incidence of AMI was 6% in patients with cocaine-associated chest pain. This result is identical to that found in prior prospective studies.

Randomized, double-blind, placebo-controlled trial of diazepam, nitroglycerin, or both for treatment of patients with potential cocaine-associated acute coronary syndromes.

INTRODUCTION: To the authors' knowledge, treatment of patients with cocaine-associated acute coronary syndromes has not been rigorously investigated in symptomatic patients. OBJECTIVE: To perform a randomized double-blind trial of diazepam, nitroglycerin, or both for treatment of patients with potential cocaine-associated acute coronary syndromes. METHODS: Patients with potential cocaine-associated acute coronary syndromes were randomized to treatment with either diazepam, nitroglycerin, or both every 5 minutes or until symptom resolution. Outcomes were chest pain resolution (measured by visual analog scale), and changes in blood pressure, pulse rate, cardiac output (L/min), cardiac index (L/min/m2), stroke volume (mL/beat), and stroke index (mL/beat/m2) over the 15-minute treatment period. To adjust for seven outcomes using the Bonferroni correction, alpha was set at 0.007. RESULTS: Forty patients were enrolled (diazepam, 12; nitroglycerin, 13; both, 15). Patients had a mean age (+/-SD) of 35.4 (+/-7.5) years; 75% were male. They presented a mean of 5 hours and 37 minutes after cocaine use. Baseline demographics, cocaine use patterns, chest pain characteristics, and initial electrocardiograms were similar for all groups. Chest pain severity improved similarly in the three groups [-33.3 mm (+/-8.0); -30.7 mm (+/-7.1); -33.0 mm (+/-7.9); p = 0.6]. The stroke index decreased during the 15-minute treatment period for all groups (diazepam, -8.7 (+/-3.3); nitroglycerin, -3.1 +/- 2.8; both, -1.8 (+/-3.1) mL/beat/m2; p = 0.03). After adjustment for differences between baseline hemodynamic and cardiac profiles and multiple comparisons, there was no difference in any response to therapy over time for the different treatments. CONCLUSIONS: For treatment of patients with potential cocaine-associated acute coronary syndromes, chest pain resolutions and changes in cardiac performance are not different in patients treated with diazepam or nitroglycerin. In this study, the use of both agents did not offer any advantage over either agent alone.

Cardiac and hemodynamic assessment of patients with cocaine-associated chest pain syndromes.

BACKGROUND: Animal and human experimental studies have yielded conflicted data regarding the effects of cocaine on cardiovascular function. We studied the cardiac and hemodynamic profiles in emergency department chest pain patients following recent cocaine use. METHODS: After obtaining informed consent, emergency department patients who presented with a chief complaint of chest pain and cocaine use within 24 hours of arrival were prospectively enrolled. All patients underwent a structured 40-item history and physical examination and were placed on the IQ Noninvasive Hemodynamic Surveillance System (Renaissance Technology, Inc., Newton, PA), a validated transthoracic cardiac output monitor. The principal measurements obtained included cardiac output, cardiac index, and stroke volume. Data were analyzed with standard descriptive techniques. RESULTS: Twenty-seven patients were enrolled (median age, 37 years [range, 23-54]; 74% male). Patients used a mean of $200 worth of cocaine, usually crack (67%). Patients had a history of tobacco use (82%), prior myocardial infarction (33%), and prior cocaine-associated chest pain (67%). The median (interquartile range; IQR) for the hemodynamic parameters were: mean arterial blood pressure 92 mm Hg (IQR 85-100); heart rate 83/min (IQR 72-98); cardiac output 6.9 L/min (IQR 5.1-7.2); cardiac index 3.2 L/min/m2 (IQR 2.4-4.0); stroke volume 78 mL/beat (IQR 64-93). CONCLUSION: Most emergency department patients with cocaine-associated chest pain have normal cardiac profiles at the time of presentation. The negative inotropic effects of high doses of cocaine observed in animal models do not appear to be present in patients who develop chest pain after using recreational doses of cocaine.

Research fundamentals: selection and development of clinical outcome measures.

Clinical outcomes measure patient health or well-being. The choice of an outcome measure for use in a clinical trial or study is complex. It is even more difficult when no appropriate outcome measure exists, necessitating the development of a novel one. The ideal clinical outcome should be credible, comprehensive, sensitive to change, accurate, biologically sensible, and feasible. This paper describes the attributes of clinical outcomes and illustrates how to develop novel outcomes, using as an example the authors' experience in developing a wound cosmesis outcome measure.

Do diabetic patients have higher in-hospital complication rates when admitted from the emergency department for possible myocardial ischemia?

OBJECTIVE: To compare in-hospital complication rates for diabetic and nondiabetic patients admitted from the emergency department (ED) for possible myocardial ischemia. METHODS: This was a prospective, observational study of consecutive consenting patients presenting to a suburban university hospital ED during study hours with typical and atypical symptoms consistent with cardiac ischemia. Demographic, historical, and clinical data were recorded by trained research assistants using a standardized, closed-question, data collection instrument. Inpatient records were reviewed by trained data abstractors to ascertain hospital course and occurrence of complications. Final discharge diagnosis of acute myocardial infarction (AMI) was assigned by World Health Organization criteria. Categorical and continuous data were analyzed by chi-square and t-tests, respectively. All tests were two-tailed with alpha set at 0.05. RESULTS: There were 1,543 patients enrolled who did not have complications at initial presentation; 283 were diabetic. The rule-in rate for AMI was 13.8% for nondiabetic patients and 17.7% for diabetic patients (p = 0.09). Times to presentation were similar for nondiabetic vs diabetic patients [248 minutes (95% CI = 231 to 266) vs 235 minutes (95% CI = 202 to 269); p = 0.32]. Nondiabetic patients tended to be younger [56.6 years (95% CI = 55.8 to 57.4) vs 61.6 years (95% CI = 60.2 to 63.1); p = 0.001] and were less likely to be female (34.3% vs 48.1%; p = 0.001). The two groups had similar prevalences for initial electrocardiograms diagnostic for AMI (5.5% vs 7.4%; p = 0.21). There was no significant difference between nondiabetic and diabetic patients for the occurrence of the following complications after admission to the hospital: congestive heart failure (1.3% vs 1.1%, p = 0.77); nonsustained ventricular tachycardia (VT) (1.3% vs 1.2%, p = 0.93); sustained VT (1.2% vs 1.1%, p = 0.85); supraventricular tachycardia (1.7% vs 3.2%, p = 0.12); bradydysrhythmias (1.9% vs 1.1%, p = 0.33); hypotension necessitating the use of pressors (0.9% vs 1.1%, p = 0.76); cardiopulmonary resuscitation (0.2% vs 0.7%, p = 0.10); and death (0.3% vs 0.7%, p = 0.34). One or more complications occurred with similar frequencies for patients in the two groups (6.3% vs 5.7%; p = 0.70). CONCLUSIONS: No statistically significant difference was found in the postadmission complication rates for initially stable diabetic vs nondiabetic patients admitted for possible myocardial ischemia. Based on these results, the presence or absence of diabetes as a comorbid condition does not indicate a need to alter admitting decisions with respect to risk for inpatient complications.

Use of the intubating laryngeal mask airway by medical and nonmedical personnel.

The intubating laryngeal mask airway (ILMA) is a newly available device designed to allow for blind endotracheal intubation and treatment of patients with difficult airways. We studied the intubation success rates and speed with initial use of this device on an intubation manikin to determine whether this device might be easily used by trained and untrained personnel. Rapid and successful intubation with a device requiring limited or no training could have widespread implications for both health care providers and laypersons. The study consisted of 2 parts. In part 1, health care providers with intubation experience, health care providers without prior intubation experience, and nonmedical personnel were instructed to enter a room and intubate a manikin using the ILMA. A single page set of schematic directions was provided within the ILMA setup. The main outcomes were the intubation success rate and the time required for successful ventilation and intubation. In part 2, participants were retested after a standardized <60 second device demonstration. The 111 participants in the study included 44 emergency physicians (40%), 21 anesthesiologists (19%), and 46 other medical or nonmedical personnel (41%). On first attempted use of the device, and with no prior training, 59% of all participants successfully intubated the manikin. Attending and resident physicians had an 83% initial success rate. The median time to ventilation was 47 seconds, and the median time from ventilation until intubation was 29 seconds. Following the <60 second demonstration, 108 of 111 (97%) participants achieved success, with the median time to ventilation 18 seconds, and the median time from ventilation until intubation 17 seconds. All attending and resident physicians succeeded in intubation following the demonstration. Success rates on first attempt correlated with level of training, prior intubation experience, and prior LMA use (all P < .001). After a <60 second demonstration, medical and nonmedical personnel with and without prior intubation training can successfully use the ILMA to rapidly establish an airway in a manikin model. The ILMA should be further studied to determine if it may permit endotracheal intubation by first responders, paramedical personnel, and other medical staff with limited or no laryngoscopy skills.