Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19.

BACKGROUND: Patients with underlying medical conditions are at increased risk for severe coronavirus disease 2019 (Covid-19). Whereas vaccine-derived immunity develops over time, neutralizing monoclonal-antibody treatment provides immediate, passive immunity and may limit disease progression and complications. METHODS: In this phase 3 trial, we randomly assigned, in a 1:1 ratio, a cohort of ambulatory patients with mild or moderate Covid-19 who were at high risk for progression to severe disease to receive a single intravenous infusion of either a neutralizing monoclonal-antibody combination agent (2800 mg of bamlanivimab and 2800 mg of etesevimab, administered together) or placebo within 3 days after a laboratory diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The primary outcome was the overall clinical status of the patients, defined as Covid-19-related hospitalization or death from any cause by day 29. RESULTS: A total of 1035 patients underwent randomization and received an infusion of bamlanivimab-etesevimab or placebo. The mean (±SD) age of the patients was 53.8±16.8 years, and 52.0% were adolescent girls or women. By day 29, a total of 11 of 518 patients (2.1%) in the bamlanivimab-etesevimab group had a Covid-19-related hospitalization or death from any cause, as compared with 36 of 517 patients (7.0%) in the placebo group (absolute risk difference, -4.8 percentage points; 95% confidence interval [CI], -7.4 to -2.3; relative risk difference, 70%; P<0.001). No deaths occurred in the bamlanivimab-etesevimab group; in the placebo group, 10 deaths occurred, 9 of which were designated by the trial investigators as Covid-19-related. At day 7, a greater reduction from baseline in the log viral load was observed among patients who received bamlanivimab plus etesevimab than among those who received placebo (difference from placebo in the change from baseline, -1.20; 95% CI, -1.46 to -0.94; P<0.001). CONCLUSIONS: Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19-related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load. (Funded by Eli Lilly; BLAZE-1 ClinicalTrials.gov number, NCT04427501.).

A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load.

BACKGROUND: Based on interim analyses and modeling data, lower doses of bamlanivimab and etesevimab together (700/1400 mg) were investigated to determine optimal dose and expand availability of treatment. METHODS: This Phase 3 portion of the BLAZE-1 trial characterized the effect of bamlanivimab with etesevimab on overall patient clinical status and virologic outcomes in ambulatory patients ≥12 years old, with mild-to-moderate coronavirus disease 2019 (COVID-19), and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700/1400 mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test. RESULTS: In total, 769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients ≥65 years of age and median duration of symptoms; 4 days). By day 29, 4/511 patients (0.8%) in the antibody treatment group had a COVID-19-related hospitalization or any-cause death, as compared with 15/258 patients (5.8%) in the placebo group (Δ[95% confidence interval {CI}] = -5.0 [-8.0, -2.1], P < .001). No deaths occurred in the bamlanivimab and etesevimab group compared with 4 deaths (all COVID-19-related) in the placebo group. Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI] = -0.99 [-1.33, -.66], P < .0001) compared with those receiving placebo. Persistently high viral load at Day 7 correlated with COVID-19-related hospitalization or any-cause death by Day 29 in all BLAZE-1 cohorts investigated. CONCLUSIONS: These data support the use of bamlanivimab and etesevimab (700/1400 mg) for ambulatory patients at high risk for severe COVID-19. Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants will require continued monitoring to determine the applicability of this treatment. CLINICAL TRIALS REGISTRATION: NCT04427501.

Bedside ultrasound for the detection of soft tissue foreign bodies: a cadaveric study.

The objective of this study was to evaluate the sensitivity and specificity of bedside ultrasound, as performed by emergency physicians with typical equipment, in detecting small, soft tissue foreign bodies, using a cadaveric model. This was a prospective study, using 6 unembalmed human cadavers and 6 ultrasound-credentialed, emergency medicine residency-trained physicians as sonographers. Incisions were made in 150 total sites of the extremities and each site was randomly assigned one of five groups: wood, metal, plastic, glass, or no foreign body. All foreign bodies were 2.5 mm3 in total volume or less, no longer than 5 mm in any dimension, and inserted to a depth of up to 3 cm. Ultrasound was performed with a SonoSite TITAN (SonoSite, Inc., Bothell, WA) ultrasound system using a L38/10-5 broadband linear array transducer. Sonographers were blinded to the number, type, and location of foreign bodies. A total of 900 ultrasound examinations were recorded. Overall sensitivity of ultrasound for foreign body detection was 52.6% (95% confidence interval [CI] 48.9%-56.2%), and overall specificity was 47.2% (95% CI 39.9%-54.5%). Positive predictive value was 79.9% (95% CI 76.3%-83.5%), and negative predictive value was 20.0% (95% CI 16.2%-23.7%). Sensitivity for individual sonographers ranged from 40.8% to 72.3% (average 52.6% +/- 13.3%), and specificity ranged from 30% to 66.7% (average 47.2% +/- 15.1%). Inter-observer reliability was poor. In our model, bedside ultrasound performed by emergency physicians was neither sensitive nor specific for the presence of small soft tissue foreign bodies.

Anesthetic and procedural sedation techniques for wound management.

Emergency physicians come across a wide variety of painful conditions and perform a large number of uncomfortable procedures on a typical shift. This article describes the local anesthetic agents and their potential applications. The peripheral nerve blocks that are regularly done in the emergency department are described. Lastly, procedural sedation and analgesia are covered, to include general principles and specific agents for its use in the emergency department.

Isopropyl alcohol pad use for blood ethanol sampling does not cause false-positive results.

This was a retrospective analysis of prospective data collected from a study of blood ethanol levels after the use of the alcohol-based hand sanitizer (ABHS). A total of 5 male volunteers were enrolled. Eight of the 10 total blood ethanol level measurements were drawn after skin preparation with Kendall WEBCOL Alcohol Preps (APP) containing 70% isopropyl alcohol. All had an initial and post-ABHS application blood alcohol level (BAL) drawn, for a total of 10 BAL measurements. Measurements upon completion of the study were <5 mg/dL in all 5 study participants and in each of the 10 blood draws regardless of skin preparation technique. This study demonstrates that the use of isopropyl skin prep pads is unlikely to cause significant false-positive blood ethanol levels.

Local anesthetics and peripheral nerve blocks in the emergency department.

The emergency physician has a variety of options for providing effective pain relief. A solid understanding of the local anesthetic agents and regional anesthetic techniques is an essential component of every emergency physician's analgesia armamentarium.

Imaging modalities in obstetrics and gynecology.

The practicing emergency physician often encounters diagnostic dilemmas involving the choice of the most appropriate radiologic study to evaluate patients in the emergency department. In addition, the uncertainty of potentially harmful fetal effects of radiation in the pregnant patient may add unnecessary delay and concern in the workup of obstetric emergencies. An emergency physician's in-depth understanding of the strengths, limitations, and potentially harmful effects of radiologic studies allows the safest and most appropriate studies to be ordered for the gynecologic and obstetric population. With the explosion of interest and growing level of expertise in focused emergency department ultrasonography during the last decade, the practicing emergency physician should add this skill to his or her armamentarium in the future. Many emergency physicians are already comfortable in using radiologic technologies in their daily practice and have discovered how quickly vital and specific information can be obtained.

Use of ultrasound to assess acute fracture reduction in emergency care settings.

OBJECTIVE: There is a need to develop tools for the rapid diagnosis and treatment of fractures and intraosseous pathology in remote and austere environments. Several emergency and orthopedic studies have demonstrated ultrasound to be a reliable tool in diagnosing these conditions in both adult and pediatric patients. The purpose of this pilot study is to assess the ability of the ultrasound to assess in "real-time" the success of fracture reduction in adult patients in the emergency department (ED), in comparison with the accepted standard, plain film radiography, for the purposes of future application in austere environments. DESIGN: Case series. SETTING: Emergency department at an academic medical center. PATIENTS/PARTICIPANTS: Convenience sample of five patients presenting to an ED with clinical evidence of fractures (three radial, one phalangeal, and one metacarpal). INTERVENTIONS: A Sonosite Titan portable ultrasound system with L38/10-5:38-mm broadband linear array transducer was used to assess prereduction and postreduction angulations and alignment. Alignment was reconfirmed with use of fluoroscopy and plain radiography. RESULTS: The ultrasound confirmed proper reduction and realignment in all five cases, from an average prereduction angle of alignment of 37.4 degrees to an average postreduction angle of 4.4 degrees. The use of the ultrasound resulted in adequate visualization of the reduction in all cases. Regional anesthesia or sedation and limited pressure with the probe resulted in no verbalization of pain by any of the subjects. CONCLUSIONS: In this pilot study, emergency physicians demonstrated the use of ultrasound in place of traditional radiography to either confirm adequate reduction or assess the need for further manipulation. Our pilot study suggests that ultrasound has a possible future role in fracture reduction management in both the ED as well as "austere"prehospital locations.

Is digital intubation an option for emergency physicians in definitive airway management?

OBJECTIVES: This study was designed to determine whether digital intubation is a valid option for definitive airway control by emergency physicians. METHODS: Digital intubation was performed by 18 emergency medicine residents and 4 staff emergency medicine physicians on 6 different cadavers. Placement was confirmed by direct laryngoscopy. The total time for all attempts used, as well as the number of attempts, was recorded. Each participant attempted intubation on all 6 cadavers. RESULTS: For 5 of the 6 cadavers, successful intubation occurred 90.9% of the time (confidence interval [CI], 85.5%-96.3%) for all participants. The average number of attempts for these 5 cadavers was 1.5 (CI, 1.4-1.7), and the average time required for success or failure was 20.8 seconds (CI, 16.9-24.8). The sixth cadaver developed soft tissue damage and a false passage near the vocal cords resulting in multiple failed attempts. CONCLUSIONS: Although the gold standard for routine endotracheal intubation remains to be direct laryngoscopy, its effectiveness in certain situations may be limited. We believe that digital intubation provides emergency physicians with another option in securing the unprotected airway.

Does the clinical use of ethanol-based hand sanitizer elevate blood alcohol levels? A prospective study.

BACKGROUND: Ethanol-based hand sanitizers (EBHSs) are used in most health care facilities in the United States. Infection control personnel advocate the use of generous quantities of EBHS before and after contact with patients. Although it is assumed that little systemic absorption of ethanol occurs during EBHS use, many alcohols are absorbed to varying degrees via the transdermal route. Ethanol intoxication by employees in the medical workplace is a potentially serious finding, and it is of forensic and medical-legal importance to elucidate the effects of frequent use of EBHS upon serum blood ethanol levels (BELs). To investigate the effect of frequent use of EBHS upon serum blood ethanol concentrations, we prospectively studied 5 volunteers undergoing frequent application of EBHS. METHODS: Enrolled subjects applied 5 mL of the product (62% denatured ethyl alcohol manufactured by Kimberley-Clark, Roswell, GA) to both hands and rubbed until dry. This activity was repeated 50 times over 4 hours. Participants had their blood drawn before as well as after completing the study. Each participant was without alcohol exposure during the 12 hours preceding the study. RESULTS: Five volunteers were enrolled. All had an initial blood ethanol level of less than 5 mg/dL. All 5 participants completed the 4-hour study. There were no noted adverse reactions during the study. Blood ethanol level upon completion of the 50 applications of EBHS was less than 5 mg/dL in all 5 study participants. CONCLUSION: The results of this study demonstrate that use of ethanol-based hand sanitizers, when frequently used in accordance with labeling, do not raise serum blood ethanol levels.