Edward A. Panacek

Airway management in the emergency department : A one-year study of 610 tracheal intubations

STUDY OBJECTIVE To describe the methods, success rates, and immediate complications of tracheal intubations performed in the emergency department of an urban teaching hospital. METHODS This was an observational, consecutive series undertaken in an urban university hospital with an emergency medicine residency training program and an annual ED census of 60,000 patients. The study population included all patients for whom intubation was attempted in the ED during a 1-year period (July 1, 1995 through June 30, 1996). At the time of each intubation, the intubator filled out an intubation data collection form. If an intubation was performed in the ED but no form was filled out, the data were obtained from the medical record. RESULTS A total of 610 patients required airway control in the ED; 569 (93%) were intubated by emergency medicine residents or attending physicians. Rapid-sequence intubation (RSI) was used in 515 (84%). A total of 603 patients (98.9%) were successfully intubated; 7 patients could not be intubated and underwent cricothyrotomy. In 33 patients, inadvertent placement into the esophagus occurred; all such situations were rapidly recognized and corrected. Eight (24%) of the 33 esophageal intubations resulted in a reported immediate complication. Overall, 49 patients (8.0%; 95% confidence interval [CI], 6% to 11%) experienced a total of 57 immediate complications (9.3%; 95% CI, 7% to 12%). Three patients sustained a cardiac arrest after intubation; two of these patients had agonal rhythms before intubation, and one probably had a succinylcholine-induced hyperkalemic cardiac arrest. CONCLUSION At this institution, the majority of ED intubations were performed by emergency physicians and RSI was the most common method used. Emergency physicians intubated critically ill and injured ED patients with a very high success rate and a low rate of serious complications.

Efficacy and safety of the monoclonal anti-tumor necrosis factor antibody F(ab')2 fragment afelimomab in patients with severe sepsis and elevated interleukin-6 levels.

Objective:To evaluate whether administration of afelimomab, an anti-tumor necrosis factor F(ab′)2 monoclonal antibody fragment, would reduce 28-day all-cause mortality in patients with severe sepsis and elevated serum levels of IL-6. Design:Prospective, randomized, double-blind, placebo-controlled, multiple-center, phase III clinical trial. Setting:One hundred fifty-seven intensive care units in the United States and Canada. Patients:Subjects were 2,634 patients with severe sepsis secondary to documented infection, of whom 998 had elevated interleukin-6 levels. Interventions:Patients were stratified into two groups by means of a rapid qualitative interleukin-6 test kit designed to identify patients with serum interleukin-6 levels above (test positive) or below (test negative) approximately 1000 pg/mL. Of the 2,634 patients, 998 were stratified into the test-positive group, 1,636 into the test-negative group. They were then randomly assigned 1:1 to receive afelimomab 1 mg/kg or placebo for 3 days and were followed for 28 days. The a priori population for efficacy analysis was the group of patients with elevated baseline interleukin-6 levels as defined by a positive rapid interleukin-6 test result. Measurements and Main Results:In the group of patients with elevated interleukin-6 levels, the mortality rate was 243 of 510 (47.6%) in the placebo group and 213 of 488 (43.6%) in the afelimomab group. Using a logistic regression analysis, treatment with afelimomab was associated with an adjusted reduction in the risk of death of 5.8% (p = .041) and a corresponding reduction of relative risk of death of 11.9%. Mortality rates for the placebo and afelimomab groups in the interleukin-6 test negative population were 234 of 819 (28.6%) and 208 of 817 (25.5%), respectively. In the overall population of interleukin-6 test positive and negative patients, the placebo and afelimomab mortality rates were 477 of 1,329 (35.9%)and 421 of 1,305 (32.2%), respectively. Afelimomab resulted in a significant reduction in tumor necrosis factor and interleukin-6 levels and a more rapid improvement in organ failure scores compared with placebo. The safety profile of afelimomab was similar to that of placebo. Conclusions:Afelimomab is safe, biologically active, and well tolerated in patients with severe sepsis, reduces 28-day all-cause mortality, and attenuates the severity of organ dysfunction in patients with elevated interleukin-6 levels.

Adequacy of Early Empiric Antibiotic Treatment and Survival in Severe Sepsis: Experience from the MONARCS Trial

As part of the Monoclonal Anti-TNF: A Randomized Controlled Sepsis (MONARCS) trial, which enrolled patients with suspected sepsis, we sought to determine whether adequate antibiotic therapy was associated with a decreased mortality rate. The study enrolled 2634 patients, 91% of whom received adequate antibiotic therapy. The mortality rate among patients given adequate antibiotic treatment was 33%, versus 43% among patients given inadequate treatment (P<.001). We conclude that adequate antibiotic therapy results in a significant decrease in the crude mortality rate among patients suspected of sepsis.

Overdiagnosis of Clostridium difficile Infection in the Molecular Test Era

IMPORTANCE Clostridium difficile is a major cause of health care-associated infection, but disagreement between diagnostic tests is an ongoing barrier to clinical decision making and public health reporting. Molecular tests are increasingly used to diagnose C difficile infection (CDI), but many molecular test-positive patients lack toxins that historically defined disease, making it unclear if they need treatment. OBJECTIVE To determine the natural history and need for treatment of patients who are toxin immunoassay negative and polymerase chain reaction (PCR) positive (Tox-/PCR+) for CDI. DESIGN, SETTING, AND PARTICIPANTS Prospective observational cohort study at a single academic medical center among 1416 hospitalized adults tested for C difficile toxins 72 hours or longer after admission between December 1, 2010, and October 20, 2012. The analysis was conducted in stages with revisions from April 27, 2013, to January 13, 2015. MAIN OUTCOMES AND MEASURES Patients undergoing C difficile testing were grouped by US Food and Drug Administration-approved toxin and PCR tests as Tox+/PCR+, Tox-/PCR+, or Tox-/PCR-. Toxin results were reported clinically. Polymerase chain reaction results were not reported. The main study outcomes were duration of diarrhea during up to 14 days of treatment, rate of CDI-related complications (ie, colectomy, megacolon, or intensive care unit care) and CDI-related death within 30 days. RESULTS Twenty-one percent (293 of 1416) of hospitalized adults tested for C difficile were positive by PCR, but 44.7% (131 of 293) had toxins detected by the clinical toxin test. At baseline, Tox-/PCR+ patients had lower C difficile bacterial load and less antibiotic exposure, fecal inflammation, and diarrhea than Tox+/PCR+ patients (P < .001 for all). The median duration of diarrhea was shorter in Tox-/PCR+ patients (2 days; interquartile range, 1-4 days) than in Tox+/PCR+ patients (3 days; interquartile range, 1-6 days) (P = .003) and was similar to that in Tox-/PCR- patients (2 days; interquartile range, 1-3 days), despite minimal empirical treatment of Tox-/PCR+ patients. No CDI-related complications occurred in Tox-/PCR+ patients vs 10 complications in Tox+/PCR+ patients (0% vs 7.6%, P < .001). One Tox-/PCR+ patient had recurrent CDI as a contributing factor to death within 30 days vs 11 CDI-related deaths in Tox+/PCR+ patients (0.6% vs 8.4%, P = .001). CONCLUSIONS AND RELEVANCE Among hospitalized adults with suspected CDI, virtually all CDI-related complications and deaths occurred in patients with positive toxin immunoassay test results. Patients with a positive molecular test result and a negative toxin immunoassay test result had outcomes that were comparable to patients without C difficile by either method. Exclusive reliance on molecular tests for CDI diagnosis without tests for toxins or host response is likely to result in overdiagnosis, overtreatment, and increased health care costs.

Cricothyrotomy: a 5-year experience at one institution.

We describe the prevalence, primary indications and immediate complications of emergency cricothyrotomy (cric) techniques, in a single institutions Emergency Department (ED) and associated air-medical transport service. This is a retrospective review at an academic, level-one trauma center with an annual ED census of 65,000 and an associated air-medical transport service (AMTS). All patients undergoing cric in the field or in the ED between July 1995 and June 2000 were included. Expert reviewers from Emergency Medicine, Trauma Surgery and the AMTS prospectively defined the complication criteria. All charts with a possible complication underwent a blinded evaluation by reviewers representing each of the three clinical services. Descriptive statistics were used to summarize the data. Fifty crics were performed over 5 years. Seventy-six percent of crics were performed in trauma patients. The prevalence of cric in patients requiring airway management in the ED was 1.1% (95% CI, 0.7-1.6) and 10.9% (95% CI, 6.9-16.1) in the field by the AMTS. The prevalence of complications was 14% (95% CI, 4-32.6) in ED patients and 54.5% (95% CI, 32-75.6) for prehospital patients. The overall inter-rater agreement for complication rate was excellent (kappa =.87). Overall, 77% of crics were performed using the rapid four-step technique (RFST). There were no reports of complications associated with the RFST when performed in the ED. Non-RFST crics in the ED had an associated complication rate of 25% (95% CI, 2.8-60). Emergency cricothyrotomy was performed in approximately 1% of all emergency airway cases in the ED and at a higher rate by the AMTS. The most frequent indications were trauma related. Additionally, the RFST was the most commonly used technique for cric at this institution. The complication rate of cric was significantly higher in the prehospital environment than in the ED.

Comparison of 2 Cricothyrotomy Techniques: Standard Method Versus Rapid 4-Step Technique

STUDY OBJECTIVE To compare the success rate, complication rate and time required for the rapid 4-step technique versus the standard technique for cricothyrotomy. METHODS We conducted a prospective, randomized crossover study. Twenty-seven emergency medicine interns, 1 junior medicine resident, and 4 senior medical students, without prior cricothyrotomy experience, were randomly divided into 2 groups. Group 1 was initially instructed in and then performed the standard technique; group 2 was initially instructed in and then performed the rapid 4-step technique. Each group was then instructed in and performed the alternate method. Cricothyrotomies were performed on preserved human cadavers. RESULTS A surgical airway was established in 28 of 32 attempts with the use of the rapid 4-step technique (88%); the average time elapsed before tube placement was 43 seconds. Thirty of 32 attempts involving the standard technique (94%) were successful; the average time to tube placement was 134 seconds (95% confidence interval for a difference of 91 seconds, 63 to 119; P < .001). Complications were identified in 12 attempts involving the standard technique (38%; 1 considered major) and in 12 involving the rapid four-step technique (38%; 3 considered major). The incidence of major complications was 6% higher for the rapid 4-step technique (95% confidence interval, -9% to 21%). CONCLUSION In a group of inexperienced subjects working on a preserved human cadaver model, the rapid 4-step technique for cricothyrotomy was performed in about one third the time required for performance of the standard technique. This finding was both clinically and statistically significant. Although the 2 techniques had similar success and complication rates, we noted a trend toward more severe complications in the rapid 4-step technique.

Effect of Oral Contrast Administration for Abdominal Computed Tomography in the Evaluation of Acute Blunt Trauma

STUDY OBJECTIVE To determine how frequently oral contrast medium (OC) is essential for computed tomography (CT) diagnosis of blunt intraabdominal injury and to quantify the delay associated with OC administration and the incidence of adverse effects. METHODS This retrospective chart review, with prospective reevaluation of CT scans for diagnostic value of OC, took place in a university teaching hospital and Level l trauma center. Participants were blunt-trauma victims admitted between June 1, 1988, and November 1, 1993, who had abdominal CT as part of their initial evaluation. Trauma registry records were used to identify study patients. Available charts and CTs were reviewed for all patients with intestinal/mesenteric and pancreatic injuries. Randomly selected cases of liver injury, spleen injury, and no intraabdominal injury were also reviewed. Blinded CT scans were reevaluated for quality of bowel opacification and value of OC to diagnostic impression. RESULTS During the study period, 2,162 blunt-trauma patients had an abdominal CT; 297 intraabdominal injuries were diagnosed in 248 patients. Full review was done on 124 charts, and 70 CT scans were reevaluated. Thirty-one (100%) of 31 liver and spleen injuries were diagnosed on CT, and OC was considered essential in none of these studies. One (4.5%) of 22 intestinal and mesenteric injuries was seen on CT, but this was the only such injury treated nonoperatively. None of 21 surgically confirmed intestinal/mesenteric injuries was seen on CT. Free air or free OC was seen in none of 7 cases of intestinal perforation. OC was judged essential in none of 20 scans in patients without intraabdominal injury. On 2 scans. OC was considered essential for the radiographic diagnosis. One of these was a normal pancreas at exploration (radiographic false-positive result). The only pancreatic injury requiring specific surgical treatment was missed on CT. Twenty-one percent of patients required placement of nasogastric tube for contrast administration after failing oral administration, and 23% vomited OC. One of 124 had documented aspiration of OC. Average additional time incurred in the ED for administration of OC was 144 minutes. CONCLUSION OC is rarely essential for CT diagnosis of intraabdominal injury. It may improve sensitivity for pancreatic injury, but it does not help identify injuries requiring surgical treatment. Even with OC, CT is insensitive for intestinal injury. Vomiting and aspiration are significant risks. Use of OC adds a significant amount of time to ED evaluation. Adverse effects of OC administration, in this setting, may outweigh its benefits.

Shock Index and Early Recognition of Sepsis in the Emergency Department: Pilot Study

Introduction: Screening for severe sepsis in adult emergency department (ED) patients may involve potential delays while waiting for laboratory testing, leading to postponed identification or over-utilization of resources. The systemic inflammatory response syndrome (SIRS) criteria are inaccurate at predicting clinical outcomes in sepsis. Shock index (SI), defined as heart rate / systolic blood pressure, has previously been shown to identify high risk septic patients. Our objective was to compare the ability of SI, individual vital signs, and the systemic inflammatory response syndrome (SIRS) criteria to predict the primary outcome of hyperlactatemia (serum lactate ≥ 4.0 mmol/L) as a surrogate for disease severity, and the secondary outcome of 28-day mortality. Methods: We performed a retrospective analysis of a cohort of adult ED patients at an academic community trauma center with 95,000 annual visits, from February 1st, 2007 to May 28th, 2008. Adult patients presenting to the ED with a suspected infection were screened for severe sepsis using a standardized institutional electronic order set, which included triage vital signs, basic laboratory tests and an initial serum lactate level. Test characteristics were calculated for two outcomes: hyperlactatemia (marker for morbidity) and 28-day mortality. We considered the following covariates in our analysis: heart rate >90 beats/min; mean arterial pressure < 65 mmHg; respiratory rate > 20 breaths/min; ≥ 2 SIRS with vital signs only; ≥2 SIRS including white blood cell count; SI ≥ 0.7; and SI ≥ 1.0. We report sensitivities, specificities, and positive and negative predictive values for the primary and secondary outcomes. Results: 2524 patients (89.4%) had complete records and were included in the analysis. 290 (11.5%) patients presented with hyperlactatemia and 361 (14%) patients died within 28 days. Subjects with an abnormal SI of 0.7 or greater (15.8%) were three times more likely to present with hyperlactatemia than those with a normal SI (4.9%). The negative predictive value (NPV) of a SI ≥ 0.7 was 95%, identical to the NPV of SIRS. Conclusion: In this cohort, SI ≥ 0.7 performed as well as SIRS in NPV and was the most sensitive screening test for hyperlactatemia and 28-day mortality. SI ≥ 1.0 was the most specific predictor of both outcomes. Future research should focus on multi-site validation, with implications for early identification of at-risk patients and resource utilization.

PROSPECTIVE EVALUATION OF CRITERIA FOR OBTAINING THORACOLUMBAR RADIOGRAPHS IN TRAUMA PATIENTS

This study examined if use of clinical screening criteria for selective radiography of blunt trauma patients can identify all patients with thoracolumbar (TL) spine injuries. The study was a prospective cohort of patients undergoing TL spine radiographs following blunt trauma. Patients were considered at risk for TL spine injury if they had any of the following clinical criteria: 1) complaints of TL spine pain, 2) TL spine tenderness, 3) a decreased level of consciousness, 4) intoxication with ethanol or drugs, 5) a neurologic deficit, or 6) a painful distracting injury. Patients without any of these findings were considered at low risk for TL spine injury. Severity of mechanism of injury was also recorded. Data sheets were completed prior to TL radiography. Injury status was determined by the final faculty radiologist interpretation of all radiographic studies. A total of 2404 patients were enrolled. TL spine injuries were identified in 152 patients. Of these 152 patients with spine injuries, all 152 (100%, 95% confidence interval 98-100%) were considered high risk by having at least one of the high-risk criteria. These criteria have a specificity of 3.9%, a positive predictive value of 6.6%, and a negative predictive value of 100%. All of the high-risk criteria but intoxication with ethanol or drugs were important as sole predictors of TL spine injury. The use of high-risk clinical screening criteria identified virtually all blunt trauma patients with acute TL spine injuries. These criteria, however, have poor specificity and positive predictive value.

Multicenter evaluation of a human monoclonal antibody to Enterobacteriaceae common antigen in patients with Gram-negative sepsis.

ObjectiveTo evaluate in Gram-negative sepsis patients the human monoclonal immunoglobulin M antibody (MAB-T88) directed at the enterobacterial common antigen which is a specific surface antigen closely linked to lipopolysaccharide and shared by all members of the Enterobacteriaceae family of Gram-negative bacteria. DesignProspective, randomized, double-blinded, placebo-controlled, multicenter trial. SettingThirty-three academic medical centers in the United States. PatientsPatients were entered with a clinical diagnosis of sepsis, the presence of either shock or multiple organ dysfunction, and presumptive evidence for Gram-negative infection. InterventionsPatients received a single intravenous infusion, over 30 mins, of either 300 mg of MAB-T88 formulated in albumin, or placebo (albumin). Measurements and Main ResultsThe primary analysis group was prospectively identified as those patients with documented evidence of an infection with bacteria of the family Enterobacteriaceae at any site. The primary end point was survival within the first 28 days. A total of 826 patients were enrolled with 55% (n = 455) in the primary analysis group. There were no significant differences between the intervention and control primary analysis group study groups for sites of infection, severity of illness, underlying medical conditions, adequacy of antibiotic or surgical treatment, or other baseline variables except for a higher frequency of chronic renal failure in the MAB-T88 group (4.4% vs. 1.3%, p = .051). The average Acute Physiology and Chronic Health Evaluation II scores were 26.8 ± 8.6 (mean ± sd) in the MAB-T88-treated group and 26.5 ± 8.3 in the placebo-treated group (p = .72). There was no significant difference between MAB-T88- and placebo-treated groups during the first 28-day all-cause mortality in the primary analysis group (34.2% vs. 30.8%, p = .44) or in all 826 patients enrolled (37.0% vs. 34.0%, p = .36). On subset analysis, the use of MAB-T88 was not associated with significant mortality trends. More adverse events were seen with the use of MAB-T88 in the bacteremic enterobacterial common antigen group (p < .05). ConclusionsUse of the human monoclonal antibody, MAB-T88, did not improve the mortality in patients with presumed Gram-negative sepsis or in those patients with proven enterobacterial common antigen infections. No subset trends were identified that would support further investigation of this agent in sepsis.