Charles J. Gerardo

Clinical Policy: Procedural Sedation and Analgesia in the Emergency Department

This clinical policy from the American College of Emergency Physicians is the revision of a 2005 clinical policy evaluating critical questions related to procedural sedation in the emergency department.1 A writing subcommittee reviewed the literature to derive evidence-based recommendations to help clinicians answer the following critical questions: (1) In patients undergoing procedural sedation and analgesia in the emergency department,does preprocedural fasting demonstrate a reduction in the risk of emesis or aspiration? (2) In patients undergoing procedural sedation and analgesia in the emergency department, does the routine use of capnography reduce the incidence of adverse respiratory events? (3) In patients undergoing procedural sedation and analgesia in the emergency department, what is the minimum number of personnel necessary to manage complications? (4) Inpatients undergoing procedural sedation and analgesia in the emergency department, can ketamine, propofol, etomidate, dexmedetomidine, alfentanil and remifentanil be safely administered? A literature search was performed, the evidence was graded, and recommendations were given based on the strength of the available data in the medical literature.

Does This Patient Have a Severe Upper Gastrointestinal Bleed

CONTEXT Emergency physicians must determine both the location and the severity of acute gastrointestinal bleeding (GIB) to optimize the diagnostic and therapeutic approaches. OBJECTIVES To identify the historical features, symptoms, signs, bedside maneuvers, and basic laboratory test results that distinguish acute upper GIB (UGIB) from acute lower GIB (LGIB) and to risk stratify those patients with a UGIB least likely to have severe bleeding that necessitates an urgent intervention. DATA SOURCES A structured search of MEDLINE (1966-September 2011) and reference lists from retrieved articles, review articles, and physical examination textbooks. STUDY SELECTION High-quality studies were included of adult patients who were either admitted with GIB or evaluated in emergency departments with bedside evaluations and/or routine laboratory tests, and studies that did not include endoscopic findings in prediction models. The initial search yielded 2628 citations, of which 8 were retained that tested methods of identifying a UGIB and 18 that identified methods of determining the severity of UGIB. DATA EXTRACTION One author abstracted the data (prevalence, sensitivity, specificity, and likelihood ratios [LRs]) and assessed methodological quality, with confirmation by another author. Data were combined using random effects measures. DATA SYNTHESIS The majority of patients (N = 1776) had an acute UGIB (prevalence, 63%; 95% CI, 51%-73%). Several clinical factors increase the likelihood that a patient has a UGIB, including a patient-reported history of melena (LR range, 5.1-5.9), melenic stool on examination (LR, 25; 95% CI, 4-174), a nasogastric lavage with blood or coffee grounds (LR, 9.6; 95% CI, 4.0-23.0), and a serum urea nitrogen:creatinine ratio of more than 30 (summary LR, 7.5; 95% CI, 2.8-12.0). Conversely, the presence of blood clots in stool (LR, 0.05; 95% CI, 0.01-0.38) decreases the likelihood of a UGIB. Of the patients clinically diagnosed with acute UGIB, 36% (95% CI, 29%-44%) had severe bleeding. A nasogastric lavage with red blood (summary LR, 3.1; 95% CI, 1.2-14.0), tachycardia (LR, 4.9; 95% CI, 3.2-7.6), or a hemoglobin level of less than 8 g/dL (LR range, 4.5-6.2) increase the likelihood of a severe UGIB requiring urgent intervention. A Blatchford score of 0 (summary LR, 0.02; 95% CI, 0-0.05) decreases the likelihood that a UGIB requires urgent intervention. CONCLUSIONS Melena, nasogastric lavage with blood or coffee grounds, or serum urea nitrogen:creatinine ratio of more than 30 increase the likelihood of a UGIB. Blood clots in the stool make a UGIB much less likely. The Blatchford clinical prediction score, which does not require nasogastric lavage, is very efficient for identifying patients who do not require urgent intervention.

Analysis of traumatic injuries presenting to a referral hospital emergency department in Moshi, Tanzania

BackgroundInjuries represent a significant and growing public health concern in the developing world, yet their impact on patients and the emergency health-care system in the countries of East Africa has received limited attention. This study evaluates the magnitude and scope of injury related disorders in the population presenting to a referral hospital emergency department in northern Tanzania.MethodsA retrospective chart review of patients presenting to the emergency department at Kilimanjaro Christian Medical Centre was performed. A standardized data collection form was used for data abstraction from the emergency department logbook and the complete medical record for all injured patients. Patient demographics, mechanism of injury, location, type and outcomes were recorded.ResultsTen thousand six hundred twenty-two patients presented to the emergency department for evaluation and treatment during the 7-month study period. One thousand two hundred twenty-four patients (11.5%) had injuries. Males and individuals aged 15 to 44 years were most frequently injured, representing 73.4% and 57.8%, respectively. Road traffic injuries were the most common mechanism of injury, representing 43.9% of injuries. Head injuries (36.5%) and extremity injuries (59.5%) were the most common location of injury. The majority of injured patients, 59.3%, were admitted from the emergency department to the hospital wards, and 5.6%, required admission to an intensive care unit. Death occurred in 5.4% of injured patients.ConclusionsThese data give a detailed and more robust picture of the patient demographics, mechanisms of injury, types of injury and patient outcomes from similar resource-limited settings.

The Rapid Impact on Mortality Rates of a Dedicated Care Team Including Trauma and Emergency Physicians at an Academic Medical Center

BACKGROUND Trauma center designation can result in improved patient outcomes after injuries. Whereas the presence of trauma teams has been associated with improved trauma patient outcomes, the specific components, including the role of emergency medicine (EM)-trained, board-certified emergency physicians, have not been defined. OBJECTIVE To assess the outcomes of patients before and after the establishment of a dedicated trauma team that incorporated full-time EM-trained physicians with trauma specialists at a Level I trauma center at an academic institution. METHODS Secondary analysis of prospectively collected trauma registry data was performed to compare mortality rates of all treated trauma patients before and after this intervention. RESULTS The establishment of a dedicated specialty trauma team incorporating full-time EM presence including EM-trained, board-certified emergency physicians was associated with a reduction in overall non-DOA (dead on arrival) mortality rate from 6.0% to 4.1% from the time period preceding (1999-2000) to the time period after (2002-2003) this intervention (1.9% absolute reduction in mortality, 95% confidence interval [CI] 0.7%-3.0%). Among patients who were most severely injured (Injury Severity Score [ISS] ≥ 25), mortality rates decreased from 30.2% to 22.0% (8.3% absolute reduction in mortality, 95% CI 2.1%-14.4%). In comparison, there was minimal change in national mortality rates for patients with ISS ≥ 25 during the same time period (33% to 34%). CONCLUSIONS The implementation of a dedicated full-time trauma team incorporating both trauma surgeons and EM-trained, board-certified or -eligible emergency physicians was associated with improved mortality rates in trauma patients treated at a Level I academic medical center, including those patients presenting with the most severe injuries.

A prospective registry evaluating the epidemiology and clinical care of traumatic brain injury patients presenting to a regional referral hospital in Moshi, Tanzania: challenges and the way forward.

Traumatic brain injury (TBI) is the most common cause of death and disability globally disproportionately affecting low- and middle-income countries where increasing injury rates are compounded by limited quality care. The objective of this study is to describe quality of care for TBI patients who presented to Kilimanjaro Christian Medical Center, Moshi, Tanzania. We evaluated a prospective quality improvement TBI registry that enrolled consecutive patients with acute TBI. Descriptive statistics and qualitative comparative analysis was performed. Overall, 893 TBI patients were enrolled during the study period, with a mean age of 32.1 years and who were mostly (80%) male. 12.9% suffered severe TBI (GCS < 9). Most injuries were road traffic (66%) especially motorcyclists (49%) and 26.8% were alcohol related. One intubation occurred, and 22.9% of hypoxic patients received oxygen. Severe TBI mortality was 47%. TBI affects men 15–45 years old in traffic crashes with high mortality for severe TBI (47%) patients. Care addressing secondary injury, hypoxemia, and hypotension is limited.

An observation unit may help improve an institution's Press Ganey satisfaction score.

BACKGROUND : Hospitals measure patient satisfaction through Press Ganey (PG) surveys. The impact of an emergency department observation unit (EDOU) on patient satisfaction has not been reported to date. We hypothesize that an EDOU has a positive impact on patient satisfaction results as measured by PG surveys. METHODS : This is a retrospective observational analysis of PG scores collected for 8 quarters before the opening of a 13-bed EDOU in January 2002 and compared with 6 quarters post-EDOU opening, starting April 1, 2003, at a tertiary care, academic, urban hospital. The facility, physician staffing, nursing, and wait times all remained the same during this period. Mean values and a 95% confidence interval (CI) are reported and statistical significance is calculated using a t test. Significance is defined as a P < 0.05. RESULTS : The mean overall PG scores pre-EDOU was 75.2 (95% CI: 74.2-76.2) and post-EDOU was 80.2 (95% CI: 78.9-82.6), which is statistically significant (P = 0.00005). Of 9 scoring categories, 9 increased post-EDOU. Other than the category for physician scores, all other mean values were higher for the EDOU in the subcategories. CONCLUSION : The introduction of an observation unit appears to be associated with a statistical improvement in patient satisfaction scores as reported by PG, in the setting of same facility, physician staffing, and nursing staffing.

The Efficacy of Crotalidae Polyvalent Immune Fab (Ovine) Antivenom Versus Placebo Plus Optional Rescue Therapy on Recovery From Copperhead Snake Envenomation: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

Study objective Copperhead snake (Agkistrodon contortrix) envenomation causes limb injury resulting in pain and disability. It is not known whether antivenom administration improves limb function. We determine whether administration of antivenom improves recovery from limb injury in patients envenomated by copperhead snakes. Methods From August 2013 through November 2015, we performed a multicenter, randomized, double‐blind, placebo‐controlled, clinical trial to evaluate the effect of ovine Crotalidae polyvalent immune Fab (ovine) (CroFab; FabAV) antivenom therapy on recovery of limb function in patients with copperhead snake envenomation at 14 days postenvenomation. The study setting was 18 emergency departments in regions of the United States where copperhead snakes are endemic. Consecutive patients aged 12 years or older with mild‐ to moderate‐severity envenomation received either FabAV or placebo. The primary outcome was limb function 14 days after envenomation, measured by the Patient‐Specific Functional Scale. Additional outcomes included the Patient‐Specific Functional Scale at other points; the Disorders of the Arm, Shoulder, and Hand, Lower Extremity Functional Scale, and Patient’s Global Impression of Change instruments; grip strength; walking speed; quality of life (Patient‐Reported Outcomes Measurement Information System Physical Fucntion‐10); pain; and analgesic use. Results Seventy‐four patients received study drug (45 FabAV, 29 placebo). Mean age was 43 years (range 12 to 86 years). Fifty‐three percent were men, 62% had lower extremity envenomation, and 88% had mild initial severity. The primary outcome, the least square mean Patient‐Specific Functional Scale score at 14 days postenvenomation, was 8.6 for FabAV‐treated subjects and 7.4 for placebo recipients (difference 1.2; 95% confidence interval 0.1 to 2.3; P=.04). Additional outcome assessments generally favored FabAV. More FabAV‐treated subjects experienced treatment‐emergent adverse events (56% versus 28%), but few were serious (1 in each group). Conclusion Treatment with FabAV reduces limb disability measured by the Patient‐Specific Functional Scale 14 days after copperhead envenomation.

Copperhead snakebite treated with crotalidae polyvalent immune fab (ovine) antivenom in third trimester pregnancy.

To contribute to the growing literature on the use of Crotaline Fab antivenom (CroFab™, Protherics, Nashville, TN), we submit what we believe is the first reported successful use of CroFab™ in a third trimester pregnant patient. A 32-year-old female at 28 5/7 weeks gestation presented to our Emergency Department (ED) having sustained a copperhead (sp. Agkistrodon contortrix) snakebite on her right foot. Within an hour of the bite, she presented with painful swelling to the right foot and ankle. She was awake and alert, with a temperature of 37.4°C, blood pressure 123/61, pulse 88, and respirations of 16/min. Her cardiac, lung, abdominal and neurological exams were normal. Her fundal height was consistent with her gestational age, and the fetal heart rate was 150 beats/ minute. A 10–12 cm area on the dorsal right foot was swollen, ecchymotic and exquisitely tender, with two fang marks on the lateral aspect. Sensation, capillary refill and range of motion were normal distally. There were no other signs of swelling, ecchymoses, petechiae or purpurae elsewhere on the skin. Laboratory data revealed a normal electrolyte panel, a hemoglobin of 12.9 g/dL and a platelet count of 136,000 cells/ mm 3 . Her prothrombin time (PT) (11.0 seconds) and INR (0.9) were normal, but her partial thromboplastin time (PTT) was elevated at 39.3 secs (range 22.2–32.2 secs).

Clinical Policy: Critical Issues in the Evaluation of Adult Patients With Suspected Transient Ischemic Attack in the Emergency Department

This clinical policy from the American College of Emergency Physicians addresses key issues for adults presenting to the emergency department with suspected transient ischemic attack. A writing subcommittee conducted a systematic review of the literature to derive evidence-based recommendations to answer the following clinical questions: (1) In adult patients with suspected transient ischemic attack, are there clinical decision rules that can identify patients at very low short-term risk for stroke who can be safely discharged from the emergency department? (2) In adult patients with suspected transient ischemic attack, what imaging can be safely delayed from the initial emergency department workup? (3) In adult patients with suspected transient ischemic attack, is carotid ultrasonography as accurate as neck computed tomography angiography or magnetic resonance angiography in identifying severe carotid stenosis? (4) In adult patients with suspected transient ischemic attack, can a rapid emergency department-based diagnostic protocol safely identify patients at short-term risk for stroke? Evidence was graded and recommendations were made based on the strength of the available data.

Ethical considerations in design of a study to evaluate a US Food and Drug Administration-approved indication: antivenom versus placebo for copperhead envenomation.

Background: In 2000, the US Food and Drug Administration approved CroFab® Crotalidae Polyvalent Immune Fab, ovine (FabAV), which had received orphan drug designation, for use in patients with minimal to moderate North American crotaline envenomations including copperhead snakes. As existing evidence on the effectiveness of FabAV for this indication is limited, wide practice variation in its use exists. In order to provide more definitive clinical evidence as to the role of this treatment, a new randomized, placebo-controlled trial of FabAV specifically for copperhead bites was initiated. Purpose: In light of the existing US Food and Drug Administration approval, ethical considerations of participation in this trial have been raised. We discuss the ethical principles pertinent to this randomized, placebo-controlled trial with placebo arm. We apply an accepted framework for ethical research to this trial. Due to the evidence gap in the literature, wide-ranging treatment recommendations by medical experts, and broad practice variation, clinical equipoise exists in the treatment of copperhead envenomation with FabAV. The impact of this clinical equipoise on the value and scientific validity of the trial is discussed. The trial’s risk–benefit ratio is also considered. Potential risks to the patients are minimized as the protocol includes a plan for rescue therapy in the event that patients progress to severe envenomation symptoms. Overall, risks are further minimized by the inclusion of an interim analysis with stopping rules based on demonstrated efficacy should the therapy clearly prove to be beneficial. Conclusion: Although a post-marketing clinical study of this nature is unusual for an approved indication, this trial adheres to all ethical preconditions found in existing guidelines for clinical research involving human subjects.