Michael R. Filbin

THE FAILED INTUBATION ATTEMPT IN THE EMERGENCY DEPARTMENT: ANALYSIS OF PREVALENCE, RESCUE TECHNIQUES, AND PERSONNEL

The aims of this study were: To describe the prevalence of Emergency Department (ED) airway management failures requiring rescue maneuvers, to describe successful rescue methods used when the primary method chosen is unsuccessful, and to characterize the roles of emergency physicians and other specialists in rescue airway management. A prospective observational study was conducted of ED airway management in 30 hospitals in the USA, Canada, and Singapore participating in the National Emergency Airway Registry (NEAR) database project. Patients were entered in the study if they underwent ED airway management, the first method chosen was not successful in achieving intubation, and a rescue technique was required. Data were collected on a structured data form for entry into a relational database with subsequent search for subjects fulfilling inclusion and exclusion criteria. Descriptive statistics were used for analysis of these data. There were 7,712 patients identified who underwent emergency intubation during the study period from January 1998 to February 2001. A total of 207 (2.7%) patient intubations met the inclusion criteria. Of these, 102 (49%) patients underwent rescue rapid sequence intubation (RSI). RSI was used after failure of oral intubation with sedation alone (n = 29), oral intubation without medications (n = 37), or blind nasotracheal intubation (n = 36). Forty-three (21%) patients underwent rescue cricothyrotomy after failure of RSI (n = 26) or other intubation methods (n = 17). Seventy-nine percent of rescue RSIs and 53% of rescue surgical airways were performed by emergency physicians. In conclusion, a total of 2.7% of emergency intubations required rescue. RSI is the most commonly used first line technique for ED airway management and is also the principal back-up technique when other oral or nasal intubation methods fail. Emergency physicians manage the majority of ED intubations, including those requiring rescue techniques.

Clinical Trial: Comparative Effectiveness of Cephalexin Plus Trimethoprim-Sulfamethoxazole Versus Cephalexin Alone for Treatment of Uncomplicated Cellulitis: A Randomized Controlled Trial

BACKGROUND Community-associated methicillin-resistant S. aureus (CA-MRSA) is the most common organism isolated from purulent skin infections. Antibiotics are usually not beneficial for skin abscess, and national guidelines do not recommend CA-MRSA coverage for cellulitis, except purulent cellulitis, which is uncommon. Despite this, antibiotics targeting CA-MRSA are prescribed commonly and increasingly for skin infections, perhaps due, in part, to lack of experimental evidence among cellulitis patients. We test the hypothesis that antibiotics targeting CA-MRSA are beneficial in the treatment of cellulitis. METHODS We performed a randomized, multicenter, double-blind, placebo-controlled trial from 2007 to 2011. We enrolled patients with cellulitis, no abscesses, symptoms for <1 week, and no diabetes, immunosuppression, peripheral vascular disease, or hospitalization (clinicaltrials.gov NCT00676130). All participants received cephalexin. Additionally, each was randomized to trimethoprim-sulfamethoxazole or placebo. We provided 14 days of antibiotics and instructed participants to continue therapy for ≥1 week, then stop 3 days after they felt the infection to be cured. Our main outcome measure was the risk difference for treatment success, determined in person at 2 weeks, with telephone and medical record confirmation at 1 month. RESULTS We enrolled 153 participants, and 146 had outcome data for intent-to-treat analysis. Median age was 29, range 3-74. Of intervention participants, 62/73 (85%) were cured versus 60/73 controls (82%), a risk difference of 2.7% (95% confidence interval, -9.3% to 15%; P = .66). No covariates predicted treatment response, including nasal MRSA colonization and purulence at enrollment. CONCLUSIONS Among patients diagnosed with cellulitis without abscess, the addition of trimethoprim-sulfamethoxazole to cephalexin did not improve outcomes overall or by subgroup. CLINICAL TRIALS REGISTRATION NCT00676130.

Sepsis visits and antibiotic utilization in U.S. emergency departments

Objectives:To monitor the frequency of sepsis visits in U.S. emergency departments and assess the appropriateness of antibiotic utilization. Design:We analyzed data from the National Hospital Ambulatory Medical Care Survey, defining sepsis as an explicit diagnosis of sepsis via International Classification of Diseases, 9th Revision, Clinical Modification codes 038, 995.91, 995.92, or 785.52. We also monitored trends using cases inferred by infection plus organ dysfunction without explicit diagnosis of sepsis, which we refer to as implicit sepsis cases. We assess changes in visit frequency and ascertain emergency department antibiotic administration rates. Setting:Four-stage probability sample of visits to U.S. emergency departments, excluding Federal/military. Patients:Adult emergency department visits, United States, 1994–2009. Measurements and Main Results:Sepsis was diagnosed explicitly at 260,000 visits per year in U.S. emergency departments (95% CI, 251,000–270,000) or 1.23 visits per 1,000 U.S. population. The visit rate remained stable from 1994 to 2009 (p for trend 0.42). By contrast, the rate of visits with an implicit diagnosis of sepsis increased by 0.07 every 2 years (95% CI, 0.04–0.10; p for trend 0.002). Antibiotics were prescribed in the emergency department during 61% (95% CI, 57–65) of explicit sepsis visits. This increased from 52% in 1994–1997 to 69% in 2006–2009 (difference, 17%; 95% CI, 16.8–17.2). Of antibiotic regimens, 18% covered methicillin-resistant Staphylococcus aureus, 27% Pseudomonas, and 10% extended-spectrum beta-lactamase–producing bacteria, without evidence of targeting according to known risk factors. Of explicit sepsis cases, 31% were admitted to the ICU with 40% mortality (95% CI, 30–51). Overall hospital mortality was 17% (95% CI, 11–22). Conclusions:Explicitly diagnosed sepsis visits did not become more common during 1994–2009. Our data suggest that many emergency department patients with sepsis do not receive antibiotics until they arrive on the inpatient unit. When antibiotics are used among septic emergency department patients, drug-resistant bacteria are covered infrequently. These methods provide a simple approach to tracking the frequency with which sepsis is diagnosed among emergency department patients and to monitoring antibiotic therapy.

Case records of the Massachusetts General Hospital. Case 2-2009. A 25-year-old man with pain and swelling of the right hand and hypotension.

From the Departments of Emergency Services (M.R.F.), Orthopaedics (D.C.R.), Radiology (L.L.A.), Pathology (R.L.K.), and Medicine (R.L.K.), Massachusetts General Hospital; the Division of Infectious Diseases, Children’s Hospital (M.R.W.); and the Departments of Surgery (M.R.F.), Orthopaedic Surgery (D.C.R.), Pediatrics (M.R.W.), Radiology (L.L.A.), Pathology (R.L.K.), and Medicine (R.L.K.), Harvard Medical School — all in Boston.

Case 2-2009

From the Departments of Emergency Services (M.R.F.), Orthopaedics (D.C.R.), Radiology (L.L.A.), Pathology (R.L.K.), and Medicine (R.L.K.), Massachusetts General Hospital; the Division of Infectious Diseases, Children’s Hospital (M.R.W.); and the Departments of Surgery (M.R.F.), Orthopaedic Surgery (D.C.R.), Pediatrics (M.R.W.), Radiology (L.L.A.), Pathology (R.L.K.), and Medicine (R.L.K.), Harvard Medical School — all in Boston.

Endothelial Permeability and Hemostasis in Septic Shock: Results from the ProCESS Trial.

Background We studied patients from the Protocolized Care in Early Septic Shock (ProCESS) trial to determine the effects of alternative resuscitation strategies on circulating markers of endothelial cell permeability and hemostasis and the association between biomarkers and mortality. Methods This was a prospective study of biomarkers of endothelial cell permeability (vascular endothelial growth factor [VEGF], soluble fms‐like tyrosine kinase 1 [sFLT‐1], angiopoietin 2 [Ang‐2]) and biomarkers of hemostasis (von Willebrand factor [vWF], thrombomodulin [TM], tissue plasminogen activator [tPA] in 605 of the 1,341 ProCESS participants in a derivation cohort and 305 participants in a validation cohort. Analyses assessed (1) the impact of varying resuscitation strategies on biomarker profiles and (2) the association of endothelial biomarkers with 60‐day in‐hospital mortality. The study was conducted in 31 US EDs in adult patients with septic shock. Patients were randomly assigned to one of three resuscitation strategies. Blood samples were collected at enrollment, at 6 h, and at 24 h. Results There were 116 (19.2%) and 52 (17.0%) deaths in the derivation and validation cohorts, respectively. There was no significant association between treatment strategy and any biomarker levels. Permeability (Ang‐2 and sFLT‐1) and hemostasis (vWF, TM, tPA) biomarkers were higher and VEGF levels were lower in nonsurvivors (P < .05 for all). At baseline, sFLT‐1 had the highest point estimate for mortality discrimination (derivation area under the curve [AUC], 0.74; validation, 0.70), similar to lactate (AUC, 0.74) and Sequential Organ Failure Assessment score (AUC, 0.73). In an analysis including all time points and adjusted for age, presence of cancer, and Charlson comorbidity score, the adjusted AUC for sFLT‐1 was 0.80. Conclusions We found no relationship between different resuscitation strategies and biomarker profiles in sepsis, but we did find that elevated levels of endothelial cell biomarkers of permeability and hemostasis were associated with increased mortality. Trial Registry ClinicalTrials.gov; No.: NCT00510835 and NCT00793442; URL: www.clinicaltrials.gov

New Mandated Centers for Medicare and Medicaid Services Requirements for Sepsis Reporting: Caution from the Field

BACKGROUND The release of the Center for Medicare and Medicaid Services (CMS) latest quality measure, Severe Sepsis/Septic Shock Early Management Bundle (SEP-1), has intensified the long-standing debate over optimal care for severe sepsis and septic shock. Although the last decade of research has demonstrated the importance of comprehensive bundled care in conjunction with compliance mechanisms to reduce patient mortality, it is not clear that SEP-1 achieves this aim. The heterogeneous and often cryptic presentation of severe sepsis and septic shock, along with the multifaceted criteria for the definition of this clinical syndrome, pose a particular challenge for fitting requirements to this disease, and implementation could have unintended consequences. OBJECTIVE Following a simulated reporting exercise, in which 50 charts underwent expert review, we aimed to detail the challenges of, and offer suggestions on how to rethink, measuring performance in severe sepsis and septic shock care. DISCUSSION There were several challenges associated with the design and implementation of this measure. The ambiguous definition of severe sepsis and septic shock, prescriptive fluid volume requirements, rigid reassessment, and complex abstraction logic all raise significant concern. CONCLUSIONS Although SEP-1 represents an important first step in requiring hospitals to improve outcomes for patients with severe sepsis and septic shock, the current approach must be revisited. The volume and complexity of the currently required SEP-1 reporting elements deserve serious consideration and revision before they are used as measures of accountability and tied to reimbursement.

Procalcitonin-Guided Use of Antibiotics for Lower Respiratory Tract Infection

BACKGROUND The effect of procalcitonin‐guided use of antibiotics on treatment for suspected lower respiratory tract infection is unclear. METHODS In 14 U.S. hospitals with high adherence to quality measures for the treatment of pneumonia, we provided guidance for clinicians about national clinical practice recommendations for the treatment of lower respiratory tract infections and the interpretation of procalcitonin assays. We then randomly assigned patients who presented to the emergency department with a suspected lower respiratory tract infection and for whom the treating physician was uncertain whether antibiotic therapy was indicated to one of two groups: the procalcitonin group, in which the treating clinicians were provided with real‐time initial (and serial, if the patient was hospitalized) procalcitonin assay results and an antibiotic use guideline with graded recommendations based on four tiers of procalcitonin levels, or the usual‐care group. We hypothesized that within 30 days after enrollment the total antibiotic‐days would be lower — and the percentage of patients with adverse outcomes would not be more than 4.5 percentage points higher — in the procalcitonin group than in the usual‐care group. RESULTS A total of 1656 patients were included in the final analysis cohort (826 randomly assigned to the procalcitonin group and 830 to the usual‐care group), of whom 782 (47.2%) were hospitalized and 984 (59.4%) received antibiotics within 30 days. The treating clinician received procalcitonin assay results for 792 of 826 patients (95.9%) in the procalcitonin group (median time from sample collection to assay result, 77 minutes) and for 18 of 830 patients (2.2%) in the usual‐care group. In both groups, the procalcitonin‐level tier was associated with the decision to prescribe antibiotics in the emergency department. There was no significant difference between the procalcitonin group and the usual‐care group in antibiotic‐days (mean, 4.2 and 4.3 days, respectively; difference, ‐0.05 day; 95% confidence interval [CI], ‐0.6 to 0.5; P=0.87) or the proportion of patients with adverse outcomes (11.7% [96 patients] and 13.1% [109 patients]; difference, ‐1.5 percentage points; 95% CI, ‐4.6 to 1.7; P<0.001 for noninferiority) within 30 days. CONCLUSIONS The provision of procalcitonin assay results, along with instructions on their interpretation, to emergency department and hospital‐based clinicians did not result in less use of antibiotics than did usual care among patients with suspected lower respiratory tract infection. (Funded by the National Institute of General Medical Sciences; ProACT ClinicalTrials.gov number, NCT02130986.)

Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Patients with Sepsis.

Objective: Fluid responsiveness is proposed as a physiology-based method to titrate fluid therapy based on preload dependence. The objectives of this study were to determine if a fluid responsiveness protocol would decrease progression of organ dysfunction, and a fluid responsiveness protocol would facilitate a more aggressive resuscitation. Methods: Prospective, 10-center, randomized interventional trial. Inclusion criteria: suspected sepsis and lactate 2.0 to 4.0 mmol/L. Exclusion criteria (abbreviated): systolic blood pressure more than 90 mmHg, and contraindication to aggressive fluid resuscitation. Intervention: fluid responsiveness protocol using Non-Invasive Cardiac Output Monitor (NICOM) to assess for fluid responsiveness (>10% increase in stroke volume in response to 5 mL/kg fluid bolus) with balance of a liter given in responsive patients. Control: standard clinical care. Outcomes: primary—change in Sepsis-related Organ Failure Assessment (SOFA) score at least 1 over 72 h; secondary—fluids administered. Trial was initially powered at 600 patients, but stopped early due to a change in sponsors funding priorities. Results: Sixty-four patients were enrolled with 32 in the treatment arm. There were no significant differences between arms in age, comorbidities, baseline vital signs, or SOFA scores (P > 0.05 for all). Comparing treatment versus Standard of Care—there was no difference in proportion of increase in SOFA score of at least 1 point (30% vs. 33%) (note bene underpowered, P = 1.0) or mean preprotocol fluids 1,050 mL (95% confidence interval [CI]: 786–1,314) vs. 1,031 mL (95% CI: 741–1,325) (P = 0.93); however, treatment patients received more fluids during the protocol (2,633 mL [95% CI: 2,264–3,001] vs. 1,002 mL [95% CI: 707–1,298]) (P < 0.001). Conclusions: In this study of a “preshock” population, there was no change in progression of organ dysfunction with a fluid responsiveness protocol. A noninvasive fluid responsiveness protocol did facilitate delivery of an increased volume of fluid. Additional properly powered and enrolled outcomes studies are needed.

Hyperglycemic hyperosmolar nonketotic coma.

Dr. Michael Filbin: Today’s case is that of a 46-yearold woman found unconscious on the floor of her apartment by her boyfriend who immediately called 911. Upon paramedic arrival the patient was noted to be unresponsive, lying on the bedroom floor. The boyfriend told paramedics that she had a history of bipolar disorder for which she took Valproic Acid. She had not been depressed recently and had never made a suicide attempt in the past. She had no known drug allergies. She did not smoke, drink alcohol, or use illicit drugs. The vital signs on EMS arrival included a heart rate of 148 beats per minute (bpm), blood pressure of 90/60 mm Hg, and shallow respirations of 14 breaths per minute. The Glascow Coma Scale was noted to be 4, with eyes opening to painful stimulus but without verbal or motor response. Dr. Eric Nadel: Are there any questions or comments at this point? Dr. Theodore Benzer: In a 46-year-old female found unresponsive with a psychiatric history, a medication overdose is a likely etiology. Did you ask the medics whether empty pill bottles were evident at the scene? Valproic Acid in overdose leads to depressed consciousness and eventual coma, although I wouldn’t expect it to account for such a rapid heart rate. In any comatose patient, definitive airway control is of primary importance, and I would strongly consider immediate endotracheal intubation in this woman. I would also advocate cardiac monitoring to elucidate the nature of the tachycardia in addition to rapid determination of the blood glucose level. Empiric naloxone also should be given at this point. Dr. Filbin: There were no pills missing from her Valproic Acid bottle, and there was no evidence in the home that would suggest a toxic ingestion. The patient was next placed on a cardiac monitor by the paramedics and was found to have ventricular tachycardia (VT) at a rate of approximately 150 bpm (Figure 1). An 18-gauge intravenous (IV) line was placed and 500 cc of normal saline was administered as a bolus. Glucometry showed a blood glucose level exceeding 500 mg/dL. Lidocaine 100 mg IV was administered, and after 2 min she converted to a sinus rhythm at approximately 70 bpm (Figure 2). Her mental status remained depressed, and she was intubated for airway protection without complication. During transport to the hospital, she had another episode of VT that again resolved with an additional 100 mg bolus of lidocaine IV. A lidocaine drip was started at 2 mg per minute IV. Dr. David Brown: The paramedics might have initially opted for immediate synchronized cardioversion in this patient with VT, hypotension, and altered mental status. If medications are chosen as primary therapy, another option would have been to administer amiodarone, which recently has been added to the Advanced Cardiovascular Life Support (ACLS) guidelines for the management of VT and wide complex tachycardia of