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Emergency Medicine

Summary: Community-Acquired Pneumonia

19 Sep, 2024 | 17:21h | UTC

Introduction

Community-acquired pneumonia (CAP) is a significant cause of morbidity and mortality, accounting for approximately 1.4 million emergency department visits, 740,000 hospitalizations, and 41,000 deaths annually in the United States. Effective management of CAP requires prompt and accurate diagnosis, appropriate antimicrobial therapy, and consideration of adjunctive treatments. This summary highlights key practice points from a review article in JAMA related to the diagnosis and treatment of CAP for medical professionals.


Diagnosis of CAP

Clinical Presentation

  • Signs and Symptoms: Suspect CAP in patients presenting with two or more of the following:
    • Fever (>38 °C) or hypothermia (≤36 °C)
    • Leukocytosis (>10,000/μL) or leukopenia (<4,000/μL)
    • New or increased cough
    • Dyspnea

Radiographic Confirmation

  • Chest Imaging: Obtain a chest radiograph for all patients with suspected CAP to identify air space opacities or infiltrates.
    • Chest CT: Consider if the chest radiograph is inconclusive but clinical suspicion remains high.
  • Differential Diagnosis: Rule out other causes of symptoms and radiographic findings, such as pulmonary embolism, heart failure, or malignancy.

Microbiological Testing

  • Viral Testing:
    • SARS-CoV-2 and Influenza: Test all patients for COVID-19 and influenza during periods of community transmission, as results influence treatment decisions and infection control measures.
  • Bacterial Testing:
    • Indications: Reserve sputum and blood cultures for patients with severe CAP or risk factors for methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa.
    • Risk Factors:
      • Previous infection or colonization with MRSA or P. aeruginosa.
      • Hospitalization with parenteral antibiotics within the past 90 days.

Treatment of CAP

Empirical Antimicrobial Therapy

  • Hospitalized Patients without Risk Factors for Resistant Bacteria:
    • First-Line Therapy: β-lactam plus macrolide combination.
      • Example: Ceftriaxone (1-2 g IV daily) plus azithromycin (500 mg IV or orally daily).
    • Alternative: Respiratory fluoroquinolone monotherapy (e.g., levofloxacin) if β-lactam/macrolide therapy is contraindicated.
  • Patients with Severe CAP:
    • Similar to non-severe CAP but ensure coverage for atypical pathogens.
    • Consider Corticosteroids: Early administration (within 24 hours) of systemic corticosteroids may reduce mortality.
  • Outpatients without Comorbidities:
    • First-Line Therapy: Amoxicillin (1 g orally three times daily) or doxycycline (100 mg orally twice daily).
  • Outpatients with Comorbidities:
    • Combination Therapy: Amoxicillin/clavulanate (500 mg/125 mg orally three times daily) plus azithromycin (500 mg on day 1, then 250 mg daily).

Duration of Therapy

  • Minimum Duration: Treat for a minimum of 3 days if the patient achieves clinical stability (normal vital signs) within 72 hours.
  • Extended Duration: Extend to 5 days or more if the patient does not meet stability criteria by day 3 or has complications.
  • Transition to Oral Therapy: Switch from intravenous to oral antibiotics when the patient can tolerate oral intake.

Antimicrobial Stewardship

  • Avoid Unnecessary Antibiotics: Do not initiate antibiotics for confirmed viral CAP without evidence of bacterial coinfection.
  • De-escalation: Narrow antibiotic coverage based on culture results and clinical improvement.
  • Monitor for Adverse Effects: Be vigilant for antibiotic-associated complications, such as Clostridioides difficile infection.

Adjunctive Therapies

  • Corticosteroids:
    • Severe CAP: Administer systemic corticosteroids (e.g., hydrocortisone 200 mg/day) within 24 hours of diagnosis to reduce mortality and complications.
    • Non-severe CAP: Routine use is not recommended due to lack of benefit and potential harm.

Secondary Prevention

  • Vaccinations:
    • Pneumococcal Conjugate Vaccine: Recommend for eligible patients to prevent future pneumococcal infections.
    • Influenza Vaccine: Annual vaccination to reduce the risk of influenza-associated pneumonia.
    • COVID-19 and RSV Vaccines: Encourage vaccination per current guidelines.
  • Lifestyle Modifications:
    • Smoking Cessation: Strongly advise quitting smoking to reduce the risk of CAP and improve respiratory health.
    • Alcohol Moderation: Counsel patients on reducing excessive alcohol intake.
  • Management of Comorbidities:
    • Optimize treatment for chronic conditions such as chronic obstructive pulmonary disease (COPD), heart failure, and diabetes.

Key Practice Points

  1. Diagnostic Evaluation:
    • Use a combination of clinical signs, symptoms, and radiographic findings to diagnose CAP.
    • Test all patients for SARS-CoV-2 and influenza during times of community prevalence.
    • Reserve extensive pathogen testing for severe cases or those at risk for resistant organisms.
  2. Antimicrobial Therapy:
    • Initiate empirical antibiotics promptly based on disease severity and risk factors.
    • Prefer β-lactam/macrolide combination therapy for most hospitalized patients.
    • Limit the duration of antibiotics to the shortest effective course to reduce resistance and adverse effects.
  3. Use of Corticosteroids:
    • Consider early corticosteroid therapy in patients with severe CAP to improve outcomes.
    • Avoid routine corticosteroid use in non-severe CAP due to potential risks.
  4. Antimicrobial Stewardship:
    • Reassess antibiotic therapy daily and de-escalate based on clinical response and microbiological data.
    • Transition to oral antibiotics when appropriate.
  5. Preventive Measures:
    • Promote vaccinations and lifestyle changes to prevent recurrent CAP.
    • Address and manage underlying health conditions that may predispose to CAP.

Conclusion

Effective management of CAP involves prompt diagnosis using clinical and radiographic criteria, appropriate empirical antimicrobial therapy tailored to disease severity and risk factors, and consideration of adjunctive treatments such as corticosteroids in severe cases. Antimicrobial stewardship principles should guide therapy duration and de-escalation to minimize resistance and adverse effects. Preventive strategies, including vaccinations and lifestyle modifications, are essential to reduce the incidence of CAP and improve patient outcomes.

Reference: Vaughn VMDickson RPHorowitz JKFlanders SA. Community-Acquired PneumoniaA ReviewJAMA. Published online September 16, 2024. doi:10.1001/jama.2024.14796

 


RCT: Preoxygenation with Noninvasive Ventilation Reduced Hypoxemia during Emergency Intubation

19 Sep, 2024 | 12:53h | UTC

Background: Hypoxemia during tracheal intubation in critically ill adults increases the risk of cardiac arrest and death. Preoxygenation aims to mitigate this risk, but the optimal method remains uncertain. Noninvasive ventilation (NIV) may offer advantages over oxygen masks by providing positive pressure and higher inspired oxygen fractions, but evidence is limited.

Objective: To determine whether preoxygenation with noninvasive ventilation reduces the incidence of hypoxemia during tracheal intubation compared to preoxygenation with an oxygen mask among critically ill adults.

Methods: In a multicenter, pragmatic, unblinded, randomized trial conducted at 24 emergency departments and intensive care units in the United States, 1301 critically ill adults (age ≥18 years) undergoing tracheal intubation were randomized 1:1 to receive preoxygenation with either noninvasive ventilation (n=645) or an oxygen mask (n=656). Patients already receiving positive-pressure ventilation or at high risk of aspiration were excluded. In the NIV group, preoxygenation was administered using a tight-fitting mask connected to a ventilator, with an FiO₂ of 100%, expiratory pressure ≥5 cm H₂O, and inspiratory pressure ≥10 cm H₂O. In the oxygen-mask group, preoxygenation was provided using a nonrebreather mask or bag-mask device without manual ventilation, with oxygen flow ≥15 liters per minute. The primary outcome was hypoxemia during intubation, defined as oxygen saturation <85% between induction of anesthesia and 2 minutes after tracheal intubation.

Results: Hypoxemia occurred in 9.1% of patients in the NIV group versus 18.5% in the oxygen-mask group (difference –9.4 percentage points; 95% CI, –13.2 to –5.6; P<0.001). Cardiac arrest during intubation occurred in 0.2% of patients in the NIV group and 1.1% in the oxygen-mask group (difference –0.9 percentage points; 95% CI, –1.8 to –0.1). Aspiration occurred in 0.9% of patients in the NIV group and 1.4% in the oxygen-mask group (difference –0.4 percentage points; 95% CI, –1.6 to 0.7). No significant differences were observed in other adverse events.

Conclusions: Preoxygenation with noninvasive ventilation significantly reduced the incidence of hypoxemia during tracheal intubation among critically ill adults compared to preoxygenation with an oxygen mask, without increasing the risk of aspiration.

Implications for Practice: Preoxygenation with noninvasive ventilation should be considered for critically ill adults undergoing emergency tracheal intubation to reduce the risk of hypoxemia and potential cardiac arrest. Clinicians should ensure appropriate equipment and training are available for the use of NIV during preoxygenation.

Study Strengths and Limitations: Strengths include a large sample size, multicenter design across diverse emergency departments and ICUs, and pragmatic approach enhancing generalizability. Limitations include exclusion of patients already receiving positive-pressure ventilation or at high risk of aspiration, potentially limiting applicability to these populations. The unblinded design may introduce bias, although outcome data were collected by independent observers.

Future Research: Further studies are needed to evaluate the effectiveness of noninvasive ventilation for preoxygenation in patients at high risk of aspiration and to compare its efficacy with high-flow nasal cannula. Research should also assess long-term clinical outcomes and cost-effectiveness of implementing NIV for preoxygenation.

Reference: Gibbs K.W., et al. (2024) Noninvasive Ventilation for Preoxygenation during Emergency Intubation. New England Journal of Medicine. DOI: http://doi.org/10.1056/NEJMoa2313680

 


RCT: High-Intensity NPPV Reduced Criteria for Intubation in Acute COPD Exacerbations

16 Sep, 2024 | 16:50h | UTC

Background: Acute exacerbations of chronic obstructive pulmonary disease (COPD) often lead to hypercapnic respiratory failure requiring ventilatory support. Noninvasive positive pressure ventilation (NPPV) is standard care, commonly delivered at low intensity with lower inspiratory pressures. However, approximately 15% of patients still require endotracheal intubation despite low-intensity NPPV. High-intensity NPPV, using higher inspiratory pressures to achieve greater reductions in PaCO₂, has shown benefits in stable hypercapnic COPD patients, but its effect during acute exacerbations is unclear.

Objective: To determine whether high-intensity NPPV reduces the need for endotracheal intubation in patients with acute COPD exacerbations and persistent hypercapnia compared to low-intensity NPPV.

Methods: In a multicenter, randomized clinical trial conducted at 30 respiratory wards in China from January 2019 to January 2022, 300 patients with acute COPD exacerbations and PaCO₂ greater than 45 mm Hg after 6 hours of low-intensity NPPV were enrolled. Participants were randomized 1:1 to receive either high-intensity NPPV (inspiratory positive airway pressure [IPAP] adjusted to achieve tidal volumes of 10–15 mL/kg predicted body weight, typically IPAP 20–30 cm H₂O) or to continue low-intensity NPPV (IPAP adjusted for tidal volumes of 6–10 mL/kg, maximum IPAP 20 cm H₂O). Patients in the low-intensity group meeting prespecified criteria for intubation were allowed to crossover to high-intensity NPPV. The primary outcome was the need for endotracheal intubation during hospitalization, defined by prespecified clinical and gas exchange criteria. Secondary outcomes included actual endotracheal intubation rates, mortality, length of hospital stay, and adverse events.

Results: Of the 300 patients (mean age 73 years; 68% male), the primary outcome occurred in 4.8% of the high-intensity group versus 13.7% of the low-intensity group (absolute difference –9.0%; 95% CI, –15.4% to –2.5%; one-sided P = .004; adjusted risk ratio [RR], 0.35; 95% CI, 0.14–0.76). However, actual endotracheal intubation rates did not differ significantly between groups (3.4% vs 3.9%; absolute difference –0.5%; 95% CI, –4.8% to 3.7%; P = .81). The high-intensity group had greater reductions in PaCO₂ levels over 72 hours (mean PaCO₂ at 72 hours: 53 mm Hg vs 64 mm Hg; P < .001) and higher rates of achieving normocapnia (21.8% vs 4.6%; P < .001). Abdominal distension occurred more frequently in the high-intensity group (37.4% vs 25.5%; absolute difference 11.9%; 95% CI, 1.5%–22.4%; P = .03), but other adverse events and serious adverse events were similar between groups.

Conclusions: High-intensity NPPV reduced the proportion of patients meeting criteria for endotracheal intubation compared to low-intensity NPPV in patients with acute COPD exacerbations and persistent hypercapnia. However, actual intubation rates did not differ, possibly due to crossover from low- to high-intensity NPPV in patients meeting intubation criteria.

Implications for Practice: High-intensity NPPV may be considered for patients with acute COPD exacerbations who remain hypercapnic after initial low-intensity NPPV, as it may reduce progression to severe respiratory failure requiring intubation criteria. Clinicians should monitor for abdominal distension and potential alkalosis, although these did not significantly affect overall tolerance or safety.

Study Strengths and Limitations: Strengths include the multicenter randomized design, clear enrollment criteria, and standardized protocols. Limitations include early trial termination, unblinded interventions, potential bias due to allowed crossover, and lack of power to detect differences in mortality or actual intubation rates.

Future Research: Further large-scale trials are needed to confirm these findings, assess the impact on actual intubation rates and mortality, and explore the efficacy of high-intensity NPPV in different clinical settings and patient populations, including those without prior NPPV exposure or with more severe respiratory distress.

Reference: Luo Z, Li Y, Li W, et al. Effect of High-Intensity vs Low-Intensity Noninvasive Positive Pressure Ventilation on the Need for Endotracheal Intubation in Patients With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: The HAPPEN Randomized Clinical Trial. JAMA. Published online September 16, 2024. http://doi.org/10.1001/jama.2024.15815

 


RCT: Tenecteplase Noninferior to Alteplase in Acute Ischemic Stroke

14 Sep, 2024 | 20:03h | UTC

Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality globally, with a particularly high burden in China. Intravenous thrombolysis with alteplase, administered within 4.5 hours of symptom onset, is the current standard of care. Tenecteplase, a genetically modified variant of alteplase with greater fibrin specificity and a longer half-life, allows for single-bolus administration, potentially simplifying and expediting treatment. Prior studies suggest tenecteplase may be as effective as alteplase in AIS, but data specific to Chinese patients are limited.

Objective: To determine whether tenecteplase is noninferior to alteplase in achieving excellent functional outcomes in Chinese patients with AIS treated within 4.5 hours of symptom onset.

Methods:

  • Design: Multicenter, randomized, open-label, blinded-endpoint, noninferiority trial conducted at 55 centers in China between July 2021 and July 2023.
  • Participants: 1,489 Chinese adults aged ≥18 years with AIS, National Institutes of Health Stroke Scale (NIHSS) scores of 1–25, measurable neurological deficits, and symptom onset within 4.5 hours.
  • Interventions: Patients were randomized 1:1 to receive either:
    • Tenecteplase: 0.25 mg/kg intravenous single bolus (maximum 25 mg).
    • Alteplase: 0.9 mg/kg intravenous (maximum 90 mg), with 10% as an initial bolus and the remainder infused over 1 hour.
  • Outcomes:
    • Primary Outcome: Proportion of patients achieving a modified Rankin Scale (mRS) score of 0 or 1 at 90 days (indicating no symptoms or no significant disability).
    • Secondary Outcomes: Major neurological improvement at 24 hours, mRS scores of 0–2 at 90 days, change in NIHSS score at 90 days, Barthel Index score ≥95 at 90 days.
    • Safety Outcomes: Symptomatic intracerebral hemorrhage (sICH) per ECASS III definition and all-cause mortality at 90 days.

Results:

  • Participants: 1,465 patients were included in the full analysis set (732 tenecteplase; 733 alteplase). Median age was 66 years, median NIHSS score was 6, and 30.4% were female.
  • Primary Outcome:
    • 72.7% in the tenecteplase group achieved mRS 0 or 1 at 90 days compared to 70.3% in the alteplase group.
    • Adjusted risk ratio (RR): 1.03 (95% CI, 0.97–1.09), meeting the predefined noninferiority margin (RR ≥0.937).
  • Secondary Outcomes:
    • Major Neurological Improvement at 24 Hours: 48.0% (tenecteplase) vs. 45.0% (alteplase); RR, 1.07 (95% CI, 0.96–1.19).
    • mRS 0–2 at 90 Days: 80.9% (tenecteplase) vs. 79.9% (alteplase); RR, 1.01 (95% CI, 0.96–1.06).
    • Change in NIHSS Score at 90 Days: Mean change of –3.70 (tenecteplase) vs. –3.02 (alteplase); adjusted difference, –0.45 (95% CI, –1.40 to 0.50).
    • Barthel Index ≥95 at 90 Days: 75.7% (tenecteplase) vs. 73.9% (alteplase); RR, 1.02 (95% CI, 0.96–1.08).
  • Safety Outcomes:
    • sICH: Occurred in 1.2% of patients in both groups; RR, 1.01 (95% CI, 0.37–2.70).
    • 90-Day Mortality: 4.6% (tenecteplase) vs. 5.8% (alteplase); RR, 0.80 (95% CI, 0.51–1.23).

Conclusions: Tenecteplase was noninferior to alteplase in achieving excellent functional outcomes (mRS 0 or 1) at 90 days in Chinese patients with AIS treated within 4.5 hours of symptom onset. Safety profiles, including rates of sICH and mortality, were similar between the two treatments. These findings support tenecteplase as a suitable alternative to alteplase for intravenous thrombolysis in AIS.

Implications for Practice:

  • Administration Advantage: Tenecteplase’s single-bolus administration could streamline treatment workflows and reduce door-to-needle times.
  • Efficacy and Safety: Comparable efficacy and safety profiles suggest tenecteplase can be confidently used in place of alteplase.
  • Patient Selection: Results are applicable to a broad range of AIS patients, including those with varying stroke severities and ages.

Study Strengths and Limitations:

  • Strengths: Large sample size, multicenter design, and inclusion of a real-world patient population enhance the generalizability of findings.
  • Limitations: Open-label design may introduce bias despite blinded endpoint assessments. The relatively low proportion of patients undergoing thrombectomy limits conclusions about combined therapy.

Future Research:

  • Further studies could explore the effectiveness of tenecteplase in specific subgroups, such as patients with large vessel occlusions or those requiring endovascular interventions.
  • Investigations into long-term outcomes beyond 90 days and real-world implementation strategies may provide additional insights.

Reference: Meng, X., et al. (2024). Tenecteplase vs alteplase for patients with acute ischemic stroke: The ORIGINAL randomized clinical trial. JAMA. DOI: https://doi.org/10.1001/jama.2024.14721

 


RCT: Invasive Strategy Does Not Significantly Improve Cardiovascular Outcomes Over Conservative Management in Older Adults with NSTEMI

7 Sep, 2024 | 13:25h | UTC

Study Design and Population: This was a prospective, multicenter, randomized trial conducted across 48 sites in the UK, enrolling 1,518 patients aged 75 years or older with non-ST-segment elevation myocardial infarction (NSTEMI). Patients were randomly assigned to receive either the best available medical therapy alone (conservative strategy) or in combination with invasive treatment (coronary angiography and revascularization). The population included individuals who were frail or had high comorbidities, with a mean age of 82 years.

Main Findings: Over a median follow-up of 4.1 years, the primary outcome (a composite of cardiovascular death or nonfatal myocardial infarction) occurred in 25.6% of the invasive-strategy group and 26.3% of the conservative-strategy group (HR, 0.94; 95% CI, 0.77–1.14; P=0.53), showing no significant difference. Cardiovascular death rates were similar between the two groups, but nonfatal myocardial infarction was lower in the invasive group (11.7% vs. 15.0%; HR, 0.75; 95% CI, 0.57–0.99). Procedural complications were rare, affecting less than 1% of patients.

Implications for Practice: This trial suggests that in older adults with NSTEMI, an invasive strategy does not significantly reduce the risk of cardiovascular death or nonfatal myocardial infarction compared to a conservative approach. The findings support the consideration of conservative management in frail elderly patients or those with significant comorbidities, given the minimal additional benefit of invasive treatment.

Reference: Kunadian, V., Mossop, H., Shields, C., Bardgett, M., Watts, P., Teare, M. D., Pritchard, J., et al. (2024). Invasive treatment strategy for older patients with myocardial infarction. New England Journal of Medicine. http://doi.org/10.1056/NEJMoa2407791

Link: https://www.nejm.org/doi/10.1056/NEJMoa2407791

 


Systematic Review: Nasogastric Feeding Increases Diarrhea and Pain Compared to Nasojejunal Feeding in Acute Pancreatitis – BMC Gastroenterol

18 Aug, 2024 | 19:23h | UTC

Study Design and Population: This systematic review and meta-analysis compared the safety and efficacy of nasogastric (NG) versus nasojejunal (NJ) feeding initiated within 48 hours of hospital admission in patients with moderate to severe acute pancreatitis. The analysis included four randomized controlled trials (RCTs) involving a total of 217 patients.

Main Findings: The review found no significant difference in mortality between NG and NJ feeding groups. However, NG feeding was associated with a higher incidence of diarrhea (RR 2.75, P = 0.02) and pain (RR 2.91, P = 0.002). The risk of infection was also higher in the NG group (6.67% vs. 3.33%, P = 0.027). No significant differences were observed in the need for surgical intervention, the requirement for parenteral nutrition, or the success rates of feeding procedures.

Implications for Practice: The findings suggest that while NG feeding does not increase mortality in acute pancreatitis, it is associated with higher rates of certain complications, particularly diarrhea and pain. Clinicians should consider these risks when choosing a feeding strategy for patients with acute pancreatitis, especially within the critical early 48-hour period post-admission.

Reference: Wang M, Shi H, Chen Q, Su B, Dong X, Shi H, Xu S. (2024). Comparative safety assessment of nasogastric versus nasojejunal feeding initiated within 48 hours post-admission versus unrestricted timing in moderate or severe acute pancreatitis: a systematic review and meta-analysis. BMC Gastroenterology, 24(207), 1-11. DOI: 10.1186/s12876-024-03290-z.

 


Randomized Noninferiority Trial: Oral Vonoprazan Noninferior to IV Proton Pump Inhibitors in Preventing Rebleeding of High-Risk Peptic Ulcers – Gastroenterology

18 Aug, 2024 | 18:32h | UTC

Study Design and Population: This multicenter, randomized, open-label, noninferiority trial was conducted in Thailand across six centers, including both university and community hospitals. A total of 194 patients with high-risk peptic ulcer (PU) bleeding who had achieved successful endoscopic hemostasis were randomized to receive either vonoprazan or intravenous proton pump inhibitors (PPI). The study aimed to compare the efficacy of vonoprazan, a potassium-competitive acid blocker, with that of high-dose PPIs in preventing rebleeding.

Main Findings: The trial found that the 30-day rebleeding rate in the vonoprazan group was 7.1%, compared to 10.4% in the PPI group. This demonstrated noninferiority of vonoprazan within a 10% margin (risk difference: -3.3%, 95% CI: -11.2 to 4.7; P < .001). The 3-day and 7-day rebleeding rates were also noninferior. Secondary outcomes, including mortality rates, the need for rescue therapy, blood transfusion requirements, and length of hospital stay, were comparable between the two groups. Adverse events were similar in both groups.

Implications for Practice: Vonoprazan presents a viable alternative to intravenous PPIs for preventing rebleeding in patients with high-risk PU after endoscopic hemostasis. The availability of vonoprazan in oral form could potentially reduce hospital stays. However, further studies in multiethnic populations are needed to confirm these findings and assess the cost-effectiveness of vonoprazan in this setting.

Reference: Geeratragool T, Kaosombatwattana U, Boonchote A, et al. (2024). Comparison of Vonoprazan Versus Intravenous Proton Pump Inhibitor for Prevention of High-Risk Peptic Ulcers Rebleeding After Successful Endoscopic Hemostasis: A Multicenter Randomized Noninferiority Trial. Gastroenterology, -(-), 1-10. DOI: https://doi.org/10.1053/j.gastro.2024.03.036.

 


Non-Inferiority Trial: Burr-Hole Drainage Without Irrigation Results in Higher Reoperation Rate in Chronic Subdural Hematoma – The Lancet

18 Aug, 2024 | 18:17h | UTC

Study Design and Population: This Finnish, nationwide, multicentre, randomised, controlled non-inferiority trial (FINISH) evaluated whether subdural irrigation during burr-hole drainage for chronic subdural haematoma could be omitted without compromising outcomes. The trial enrolled 589 adults (165 women, 424 men) requiring burr-hole drainage, randomly assigned to receive drainage with or without irrigation.

Main Findings: The study found a 6.0 percentage point higher reoperation rate within 6 months in the non-irrigation group (18.3%) compared to the irrigation group (12.6%). There were no significant differences in secondary outcomes, including the proportion of patients with an unfavorable functional outcome (13.1% vs. 12.6%) or mortality (6.1% vs. 7.1%). Adverse events were comparable between the groups.

Implications for Practice: The trial results suggest that omitting subdural irrigation during burr-hole drainage increases the risk of reoperation, without improving functional outcomes or reducing mortality. The findings support the continued use of subdural irrigation in this procedure.

Reference: Raj, R., Tommiska, P., Koivisto, T., Leinonen, V., Danner, N., & Posti, J. P., et al. (2024). Burr-hole drainage with or without irrigation for chronic subdural haematoma (FINISH): A Finnish, nationwide, parallel-group, multicentre, randomised, controlled, non-inferiority trial. The Lancet, 403(10446), 2798-2806. DOI: https://doi.org/10.1016/S0140-6736(24)00686-X.

 


Innovative Antimicrobial Susceptibility Testing Bypasses Blood Culture, Promising Faster Sepsis Diagnosis – Nature

18 Aug, 2024 | 14:09h | UTC

Study Design and Population: This study introduces a novel ultra-rapid antimicrobial susceptibility testing (AST) method that bypasses the traditional blood culture process, potentially reducing diagnostic time by 40-60 hours. The method was evaluated using a cohort of 190 hospitalized patients in Korea with suspected sepsis, including those with blood cancers.

Main Findings: The new AST method identified bacterial species in all patients with positive blood infections, achieving a 100% match in species identification. For antimicrobial susceptibility, the method demonstrated a 94.9% categorical agreement with conventional AST methods, with a theoretical turnaround time of 13 ± 2.53 hours, significantly faster than current workflows.

Implications for Practice: This method could improve sepsis treatment by providing same-day results, potentially reducing sepsis-related mortality and the use of broad-spectrum antibiotics. However, further validation in a more diverse patient population is necessary to confirm its clinical efficacy and value.

Reference: Kim, T. H., Kang, J., Jang, H., Joo, H., Lee, G. Y., Kim, H., et al. (2024). Blood culture-free ultra-rapid antimicrobial susceptibility testing. Nature, (2024).

 


Review: Prevention and Management of Device-Associated Complications in the Intensive Care Unit – The BMJ

17 Aug, 2024 | 20:04h | UTC

Introduction:

This review article, published by experts from the David Geffen School of Medicine at UCLA, focuses on the complications associated with invasive devices commonly used in the Intensive Care Unit (ICU). While these devices are essential for managing critically ill patients, they also pose significant risks, necessitating a thorough understanding of their potential complications and strategies for prevention and management.

Key Points:

1 – Central Venous Catheters (CVCs):

– CVCs are widely used in ICU patients but carry risks like vascular injury, pneumothorax, thrombosis, and infection.

– Use of real-time ultrasound guidance and careful operator technique are crucial for minimizing these risks.

– Prompt removal of unnecessary CVCs is essential to reduce the risk of complications.

2 – Arterial Catheters:

– Commonly used for hemodynamic monitoring, these catheters can lead to complications such as vascular occlusion, nerve injury, and infection.

– Ultrasound guidance is recommended to reduce the risk of complications, and catheters should be discontinued as soon as clinically feasible.

3 – Airway Devices (Endotracheal Tubes and Tracheostomies):

– Complications include laryngeal injury, tracheal stenosis, and tracheomalacia.

– Strategies to reduce these risks include minimizing intubation attempts, ensuring proper tube placement, and managing cuff pressures carefully.

4 – Extracorporeal Membrane Oxygenation (ECMO):

– ECMO is associated with significant complications, including bleeding, thromboembolic events, and neurologic injuries.

– Proper cannulation technique and vigilant monitoring are essential to mitigate these risks.

5 – Infection Control:

– Strict adherence to aseptic techniques and the use of chlorhexidine-impregnated dressings are recommended to prevent device-associated infections.

Conclusion:

This review underscores the importance of judicious use and timely removal of invasive devices in the ICU to minimize complications. Healthcare professionals must remain vigilant and employ best practices to prevent and manage these complications effectively.

Reference: Hixson, R., Jensen, K. S., Melamed, K. H., & Qadir, N. (2024). Device associated complications in the intensive care unit. BMJ, 386, e077318. http://dx.doi.org/10.1136/bmj-2023-077318

 


Study: Novel Point-of-Care hs-cTnI Test Shows High Diagnostic Accuracy and Predictive Values for Myocardial Infarction – J Am Coll Cardiol

17 Aug, 2024 | 19:00h | UTC

Study Design and Population: This international, multicenter diagnostic study assessed the clinical and analytical performance of the new high-sensitivity cardiac troponin I (hs-cTnI)-SPINCHIP point-of-care (POC) test. The study involved 1,102 adult patients presenting with acute chest discomfort in emergency departments, with myocardial infarction (MI) diagnoses adjudicated by two independent cardiologists.

Main Findings: The hs-cTnI-SPINCHIP test exhibited strong diagnostic accuracy with an area under the receiver-operating characteristic curve of 0.94, similar to established central laboratory assays. The 0/1-hour algorithm of the test identified 51% of patients as low risk for MI with a sensitivity and negative predictive value of 100%, while it confirmed MI in 27% of patients with a specificity of 90.9% and a positive predictive value of 72.9%. Consistency was observed across different sample types.

Implications for Practice: The SPINCHIP hs-cTnI POC test provides a rapid and accurate option for diagnosing MI in emergency settings, aiding quicker decision-making for ruling out or confirming MI.

Reference: Koechlin L. et al. (2024). Clinical and Analytical Performance of a Novel Point-of-Care High-Sensitivity Cardiac Troponin I Assay. JACC, 84(8), 726–740.

 


News Release – FDA Approves First Nasal Spray for Anaphylaxis Treatment: Neffy (Epinephrine Nasal Spray) – U.S. Food and Drug Administration

17 Aug, 2024 | 15:43h | UTC

The U.S. Food and Drug Administration (FDA) has approved Neffy, the first epinephrine nasal spray for the emergency treatment of anaphylaxis and other severe allergic reactions (Type I) in both adults and pediatric patients weighing at least 30 kilograms (approximately 66 pounds). This approval introduces a non-injectable option for the rapid administration of epinephrine, which is critical in managing life-threatening allergic reactions.

Key Points for Healthcare Providers:

– Alternative to Injection: Neffy provides a new option for patients who may delay or avoid epinephrine injections due to needle phobia. This could be particularly beneficial for children and others reluctant to use injectable epinephrine.

– Efficacy and Safety: Neffy’s approval is supported by studies comparing its pharmacokinetics and pharmacodynamics to traditional epinephrine injections. These studies showed comparable blood epinephrine levels and similar physiological effects, such as increased blood pressure and heart rate.

– Administration: Neffy is a single-dose nasal spray, administered into one nostril. If symptoms do not improve or worsen, a second dose may be administered in the same nostril. Patients should still seek emergency medical care to monitor the anaphylactic reaction.

– Warnings: Certain nasal conditions, such as nasal polyps or a history of nasal surgery, may impair Neffy’s absorption. In these cases, injectable epinephrine might be a more reliable option. The product also carries typical warnings for epinephrine use, particularly in patients with coexisting conditions.

– Side Effects: Common side effects include throat irritation, nasal discomfort, headaches, and jitteriness. Healthcare professionals should discuss these with patients to ensure informed use.

Clinical Implications:

Neffy may reduce barriers to the timely treatment of anaphylaxis, potentially improving outcomes by increasing the likelihood of rapid epinephrine administration. Healthcare providers should consider Neffy as an alternative for patients who are needle-averse or have difficulty using injectable epinephrine, while also ensuring patients understand the importance of prompt medical attention following its use.

Approval Background:

Neffy was granted Fast Track designation by the FDA, emphasizing the need for an alternative to injectable epinephrine. The approval was awarded to ARS Pharmaceuticals.

Source: FDA News Release: FDA Approves First Nasal Spray for Treatment of Anaphylaxis

 


New AHA Guidelines for Managing Elevated Blood Pressure in Acute Care Settings – Hypertension

13 Aug, 2024 | 13:13h | UTC

Introduction:

The American Heart Association (AHA) has released a scientific statement focusing on the management of elevated blood pressure (BP) in acute care settings. This guideline addresses the significant variation in practice due to a lack of robust evidence for managing BP in such environments, particularly in emergencies or when elevated BP is asymptomatic.

Key Points:

1 – Classification of Elevated BP: Elevated BP in acute care settings is categorized into asymptomatic elevated BP and hypertensive emergency, the latter requiring immediate treatment due to acute target-organ damage.

2 – Hypertensive Emergency: Immediate treatment is necessary for patients with BP >180/110–120 mm Hg and evidence of new or worsening target-organ damage, typically using intravenous antihypertensive medications in a closely monitored environment.

3 – Asymptomatic Elevated BP: In cases where elevated BP is present without symptoms or target-organ damage, the use of antihypertensive medications should be approached cautiously. Recent studies suggest potential harm from aggressive treatment, highlighting the importance of verifying BP readings and identifying reversible causes before intervention.

4 – Proper BP Measurement: Accurate BP measurement is crucial. The guidelines stress using recently calibrated devices and following correct measurement techniques to avoid unnecessary treatment due to erroneous readings.

5 – PRN Orders: The use of “as needed” (PRN) antihypertensive medications for asymptomatic elevated BP is discouraged due to the risks of overtreatment and variability in BP control, which can lead to adverse outcomes.

6 – Treatment Thresholds: The guidelines recommend a high threshold for initiating or intensifying antihypertensive treatment in asymptomatic patients, emphasizing the need for repeated measurements and assessment of underlying causes.

7 – Post-Discharge Care: It is crucial to maintain prehospital antihypertensive regimens and avoid intensification at discharge unless clearly indicated. Effective care coordination and patient education are vital for successful transitions from hospital to home care.

Conclusion:

These guidelines represent a significant step toward standardizing BP management in acute care settings. By focusing on accurate measurement, cautious treatment of asymptomatic elevated BP, and proper follow-up, clinicians can reduce unnecessary interventions and improve patient outcomes.

Guideline Reference: Bress, A.P., et al. (2024). “The Management of Elevated Blood Pressure in the Acute Care Setting: A Scientific Statement from the American Heart Association.” Hypertension, 81–e106.

 


IDSA 2024 Guidelines for Managing Complicated Intra-abdominal Infections – Clin Infect Dis

10 Aug, 2024 | 22:10h | UTC

Introduction: The Infectious Diseases Society of America (IDSA) has updated its clinical practice guidelines for managing complicated intra-abdominal infections in adults, children, and pregnant individuals. The update focuses on risk assessment, diagnostic imaging, and microbiological evaluation, with recommendations grounded in systematic literature reviews and the GRADE approach for rating evidence.

Key Points:

1 – Risk Stratification:

– For adults with complicated intra-abdominal infections, the APACHE II score is recommended for risk stratification within 24 hours of hospital or ICU admission. The WSES Sepsis Severity Score is an acceptable alternative.

– No specific severity scoring system is recommended for pediatric patients.

2 – Diagnostic Imaging for Appendicitis:

– In non-pregnant adults, CT is suggested as the initial imaging modality for suspected acute appendicitis.

– For children, an abdominal ultrasound (US) is preferred initially, with MRI or CT recommended if the US is inconclusive.

– In pregnant individuals, US or MRI can be considered, with MRI suggested if initial US results are inconclusive.

3 – Imaging for Acute Cholecystitis and Cholangitis:

– For non-pregnant adults, US is recommended initially. If inconclusive, a CT scan is suggested.

– For pregnant individuals, US or MRI can be used, but the guidelines do not specify a preferred modality due to a knowledge gap.

4 – Blood Cultures:

– Blood cultures are recommended in adults and children with suspected intra-abdominal infections presenting with severe symptoms such as hypotension or tachypnea, especially when antibiotic-resistant organisms are a concern.

– Routine blood cultures are not recommended for patients without these risk factors.

5 – Intra-abdominal Fluid Cultures:

– In complicated intra-abdominal infections requiring source control procedures, obtaining intra-abdominal cultures is advised to guide antimicrobial therapy.

– In uncomplicated appendicitis cases, routine cultures are not recommended unless the patient is immunocompromised or complicated disease is suspected during surgery.

Conclusion: These guidelines provide evidence-based recommendations to improve the management of complicated intra-abdominal infections, emphasizing appropriate risk stratification, targeted diagnostic imaging, and the selective use of cultures to guide therapy.

Reference: Bonomo, R. A., et al. (2024). “2024 Clinical Practice Guideline Update by the Infectious Diseases Society of America on Complicated Intra-abdominal Infections: Risk Assessment, Diagnostic Imaging, and Microbiological Evaluation in Adults, Children, and Pregnant People.” Clinical Infectious Diseases. DOI: 10.1093/cid/ciae346.

 


Cluster RCT: AI-ECG Shows Potential to Reduce Door-to-Balloon Time and Cardiac Deaths in STEMI Patients – NEJM AI

10 Aug, 2024 | 21:57h | UTC

Study Design and Population: This open-label, cluster randomized controlled trial assessed the impact of AI-powered electrocardiogram (AI-ECG) on reducing treatment delays for ST-elevation myocardial infarction (STEMI). The study involved 43,234 patients, with an average age of 60 years, at Tri-Service General Hospital in Taiwan. Patients were randomized 1:1 into an intervention group (AI-ECG-assisted STEMI detection) or a control group receiving standard care.

Main Findings: AI-ECG significantly reduced the median door-to-balloon time for emergency department patients (82.0 vs. 96.0 minutes, P=0.002) and the ECG-to-balloon time across all settings (78.0 vs. 83.6 minutes, P=0.011). While the AI-ECG intervention did not significantly affect all-cause mortality or new-onset heart failure, it led to a notable reduction in cardiac death rates (85 vs. 116 cases; odds ratio, 0.73; P=0.029).

Implications for Practice: AI-ECG can expedite the critical time to treatment for STEMI patients, potentially reducing cardiac death. Although overall mortality remained unchanged, the reduction in cardiac deaths suggests that AI-ECG could be a valuable tool in emergency and inpatient settings to improve outcomes for STEMI patients.

Reference: Lin C. et al. (2024). Artificial Intelligence–Powered Rapid Identification of ST-Elevation Myocardial Infarction via Electrocardiogram (ARISE) — A Pragmatic Randomized Controlled Trial. NEJM AI, 1(7). DOI: 10.1056/AIoa2400190.

 


IDSA 2024 Guidelines for Treatment of Antimicrobial-Resistant Gram-Negative Infections – Clin Infect Dis

10 Aug, 2024 | 20:16h | UTC

Introduction:

The Infectious Diseases Society of America (IDSA) has released updated guidelines in 2024 addressing the treatment of infections caused by antimicrobial-resistant (AMR) Gram-negative bacteria. These guidelines cover pathogens including extended-spectrum β-lactamase-producing Enterobacterales (ESBL-E), AmpC β-lactamase-producing Enterobacterales (AmpC-E), carbapenem-resistant Enterobacterales (CRE), difficult-to-treat Pseudomonas aeruginosa (DTR P. aeruginosa), carbapenem-resistant Acinetobacter baumannii (CRAB), and Stenotrophomonas maltophilia.

Key Points:

1 – ESBL-E Infections:

– Preferred treatment for uncomplicated cystitis includes nitrofurantoin and TMP-SMX. Fluoroquinolones and carbapenems are alternatives but should be reserved to prevent resistance.

– For pyelonephritis or complicated urinary tract infections (cUTI), TMP-SMX, ciprofloxacin, or levofloxacin are preferred. Carbapenems are recommended when resistance precludes other options.

2 – AmpC-E Infections:

– Cefepime is suggested for treating infections caused by organisms at moderate risk of significant AmpC production (e.g., Enterobacter cloacae complex, Klebsiella aerogenes, and Citrobacter freundii).

– The use of cephamycins (e.g., cefoxitin, cefotetan) for treating ESBL-E infections is not recommended due to insufficient clinical outcome data.

3 – CRE Infections:

– Acknowledgement of increased prevalence of metallo-beta-lactamase (MBL)-producing CRE in the U.S.

– The combination of ceftazidime-avibactam and aztreonam is suggested for MBL-producing CRE, with updated dosing recommendations provided.

4 – DTR Pseudomonas aeruginosa:

– Traditional β-lactams (e.g., cefepime) with high-dose extended-infusion therapy are recommended.

– Tobramycin or amikacin, administered once daily, are alternatives for pyelonephritis or cUTI.

5 – CRAB and Stenotrophomonas maltophilia Infections:

– Sulbactam-durlobactam with meropenem or imipenem-cilastatin is the preferred treatment for CRAB.

– The order of preference for agents treating S. maltophilia includes cefiderocol, ceftazidime-avibactam, and aztreonam, among others.

Conclusion:

The 2024 IDSA guidelines provide critical updates on managing AMR Gram-negative infections, emphasizing the importance of selecting the appropriate antibiotic based on susceptibility, resistance mechanisms, and patient-specific factors. These guidelines are essential for optimizing treatment outcomes in the face of increasing antimicrobial resistance.

Reference:

Tamma, P. D., Heil, E. L., Justo, J. A., Mathers, A. J., Satlin, M. J., & Bonomo, R. A. (2024). Infectious Diseases Society of America Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections. Clinical Infectious Diseases.

 


RCT: Liberal vs. Restrictive Transfusion Strategy Shows No Significant Difference in Neurologic Outcomes for Traumatic Brain Injury Patients – N Engl J Med

3 Aug, 2024 | 19:06h | UTC

Study Design and Population: This randomized clinical trial evaluated the effects of liberal versus restrictive red cell transfusion strategies in 742 adults with moderate to severe traumatic brain injury (TBI) and anemia. Participants were randomized to either a liberal transfusion strategy (initiated at hemoglobin ≤10 g/dL) or a restrictive strategy (initiated at hemoglobin ≤7 g/dL). The primary outcome was an unfavorable neurologic outcome at 6 months, assessed using the Glasgow Outcome Scale–Extended.

Main Findings: The study found that 68.4% of patients in the liberal-strategy group and 73.5% in the restrictive-strategy group experienced an unfavorable outcome (adjusted absolute difference of 5.4 percentage points; 95% CI, −2.9 to 13.7). No significant difference in mortality or depression was observed between the two groups. Although some functional independence and quality of life measures were better in the liberal group among survivors, venous thromboembolic events and acute respiratory distress syndrome rates were comparable.

Implications for Practice: The findings indicate that a liberal transfusion strategy does not significantly improve neurologic outcomes at 6 months in critically ill TBI patients compared to a restrictive strategy. Clinicians may consider maintaining a restrictive transfusion strategy, given the similar outcomes and potential for fewer transfusions. Further research is needed to explore specific subgroups that might benefit from different transfusion strategies.

Reference: Turgeon AF, Fergusson DA, Clayton L, et al. (2024). Liberal or Restrictive Transfusion Strategy in Patients with Traumatic Brain Injury. New England Journal of Medicine, 390(24), 1234-1245. DOI: 10.1056/NEJMoa2404360.


RCT: Tenecteplase Reduces Disability but Not Mortality in Ischemic Stroke 4.5 to 24 Hours Post-Onset – N Engl J Med

3 Aug, 2024 | 19:03h | UTC

Study Design and Population: This randomized clinical trial was conducted in China to assess the efficacy and safety of tenecteplase in patients with ischemic stroke caused by large-vessel occlusion. The study included 516 patients who were randomly assigned to receive either tenecteplase (264 patients) or standard medical treatment (252 patients) within 4.5 to 24 hours after stroke onset. All patients had salvageable brain tissue confirmed by perfusion imaging and did not have access to endovascular thrombectomy.

Main Findings: The primary outcome, absence of disability (modified Rankin scale score of 0 or 1) at 90 days, was achieved by 33.0% of patients in the tenecteplase group compared to 24.2% in the standard treatment group (relative rate, 1.37; 95% CI, 1.04 to 1.81; P=0.03). Mortality at 90 days was similar between the two groups (13.3% for tenecteplase vs. 13.1% for standard treatment). Symptomatic intracranial hemorrhage within 36 hours occurred in 3.0% of tenecteplase-treated patients compared to 0.8% of those receiving standard treatment.

Implications for Practice: The study suggests that tenecteplase administered 4.5 to 24 hours post-stroke onset can reduce disability in patients with large-vessel occlusion who do not have access to endovascular thrombectomy. However, the increased risk of symptomatic intracranial hemorrhage warrants cautious consideration. Further research may be needed to optimize patient selection and timing of administration to balance benefits and risks.

Reference: Xiong Y et al. (2024). Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy. New England Journal of Medicine, 390(24), 2980-2992. DOI: 10.1056/NEJMoa2402980.


RCT: Reteplase More Likely to Achieve Excellent Functional Outcome Than Alteplase in Acute Ischemic Stroke – N Engl J Med

3 Aug, 2024 | 19:00h | UTC

Study Design and Population: This randomized clinical trial compared the efficacy and safety of reteplase versus alteplase in patients with acute ischemic stroke. The study involved 1,412 patients who presented within 4.5 hours of symptom onset. Patients were randomly assigned in a 1:1 ratio to receive either intravenous reteplase or intravenous alteplase.

Main Findings: The primary efficacy outcome, an excellent functional outcome (modified Rankin scale score of 0 or 1) at 90 days, was achieved in 79.5% of the reteplase group compared to 70.4% of the alteplase group (risk ratio, 1.13; 95% CI, 1.05 to 1.21; P<0.001 for noninferiority and P=0.002 for superiority). The primary safety outcome, symptomatic intracranial hemorrhage within 36 hours, was similar between groups (2.4% for reteplase vs. 2.0% for alteplase; risk ratio, 1.21; 95% CI, 0.54 to 2.75). However, reteplase was associated with a higher incidence of any intracranial hemorrhage at 90 days (7.7% vs. 4.9%; risk ratio, 1.59; 95% CI, 1.00 to 2.51) and more adverse events (91.6% vs. 82.4%; risk ratio, 1.11; 95% CI, 1.03 to 1.20).

Implications for Practice: Reteplase shows superior efficacy in achieving excellent functional outcomes compared to alteplase in acute ischemic stroke, making it a viable alternative thrombolytic agent. However, the higher risk of intracranial hemorrhage and adverse events necessitates careful patient selection and monitoring. Further research may be needed to refine dosage and administration protocols to mitigate these risks.

Reference: Li, S., Gu, H-Q., Li, H., Wang, X., Jin, A., Guo, S., Lu, G., et al. (2024). Reteplase versus Alteplase for Acute Ischemic Stroke. New England Journal of Medicine, 390(24), 2264-2273. DOI: 10.1056/NEJMoa2400314.


Randomized Controlled Trial: Mixed results with Andexanet Alfa for Factor Xa inhibitor-associated acute intracerebral hemorrhage – N Engl J Med

27 May, 2024 | 20:26h | UTC

Study Design and Population: This randomized controlled trial involved 530 patients with acute intracerebral hemorrhage who had taken factor Xa inhibitors within 15 hours before the event. They were randomly assigned to receive either andexanet alfa or usual care.

Main Findings: Hemostatic efficacy was achieved in 67% of patients receiving andexanet compared to 53.1% receiving usual care. Andexanet significantly reduced anti-factor Xa activity by 94.5%, compared to 26.9% with usual care. However, thrombotic events were more frequent in the andexanet group, including ischemic stroke.

Implications for Practice: Andexanet alfa is effective in controlling hematoma expansion in patients with factor Xa inhibitor-associated intracerebral hemorrhage but has an increased risk of thrombotic events. Further research is needed to balance efficacy and safety.

 

Reference (link to abstract – $ for full-text):

Connolly SJ, Sharma M, Cohen AT, et al. (2024). Andexanet for Factor Xa Inhibitor-Associated Acute Intracerebral Hemorrhage. New England Journal of Medicine, 390(19), 1745-1755. DOI: 10.1056/NEJMoa2313040.

 


RCT: Thrombectomy improves outcomes in acute stroke with large infarcts – N Engl J Med

25 May, 2024 | 19:35h | UTC

Study Design and Population: This randomized clinical trial investigated the efficacy of thrombectomy in combination with standard medical care versus medical care alone in patients with acute stroke and large infarcts. Participants included 333 patients with proximal cerebral vessel occlusion in the anterior circulation, presenting within 6.5 hours of symptom onset. They were randomized in a 1:1 ratio to either undergo thrombectomy or receive only medical care. An Alberta Stroke Program Early Computed Tomographic Score of ≤5 was used to define large infarcts.

Main Findings: The primary outcome, assessed by the modified Rankin scale score at 90 days, showed a median score of 4 in the thrombectomy group compared to 6 in the control group, indicating better functional outcomes with thrombectomy (generalized odds ratio, 1.63; 95% CI, 1.29 to 2.06; P<0.001). Mortality at 90 days was significantly lower in the thrombectomy group (36.1%) compared to the control group (55.5%) with an adjusted relative risk of 0.65. However, thrombectomy was associated with a higher rate of symptomatic intracerebral hemorrhage (9.6% vs. 5.7% in the control group).

Implications for Practice: The findings suggest that thrombectomy, when added to standard medical care, can significantly improve functional outcomes and reduce mortality in patients with large infarct strokes. However, the increased risk of symptomatic intracerebral hemorrhage must be considered when deciding on this intervention. These results support the broader use of thrombectomy in clinical settings with similar patient profiles but underscore the need for careful risk-benefit analysis due to the potential for serious hemorrhagic complications.

 

Reference (link to abstract – $ for full-text):

Costalat, V. et al. (2024). Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size. N Engl J Med, 390(18), 1677-1689. DOI: 10.1056/NEJMoa2314063

 


RCT: Early minimally invasive surgery may improve outcomes in selected patients with intracerebral hemorrhage – N Engl J Med

25 May, 2024 | 18:58h | UTC

Study Design and Population: This multicenter randomized clinical trial investigated the efficacy of early minimally invasive surgical removal of intracerebral hemorrhage compared to medical management alone. The trial enrolled 300 patients within 24 hours of symptom onset, who had either lobar or anterior basal ganglia hemorrhages, with hematoma volumes ranging from 30 to 80 ml. An adaptation rule was applied partway through the trial, resulting in the exclusive enrollment of patients with lobar hemorrhages after 175 patients were initially enrolled.

Main Findings: Patients in the surgery group achieved a significantly higher mean score on the utility-weighted modified Rankin scale at 180 days (0.458) compared to the control group (0.374), with a difference of 0.084 and a posterior probability of superiority of 0.981. Notably, the benefit of surgery was pronounced among patients with lobar hemorrhages (mean difference 0.127), whereas no benefit was observed in patients with anterior basal ganglia hemorrhages. Additionally, the surgery group experienced a lower 30-day mortality rate (9.3%) compared to the control group (18.0%).

Implications for Practice: The results suggest that early minimally invasive surgery for intracerebral hemorrhage, particularly for lobar hemorrhages, offers significant functional benefits over medical management alone. These findings support the selective use of this surgical approach in clinical settings, potentially leading to improved patient outcomes. Further studies could explore the differential impact of hemorrhage location on surgical outcomes to refine treatment guidelines.

 

Reference (link to abstract – $ for full-text):

Pradilla, G. et al. (2024). Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med, 390(14), 1277-1289. DOI: 10.1056/NEJMoa2308440.

 


Guidelines on the use of intravenous albumin in various clinical settings – CHEST

25 May, 2024 | 18:49h | UTC

The International Collaboration for Transfusion Medicine Guidelines provides comprehensive guidelines on the use of intravenous albumin across various clinical settings, including critical care, cardiovascular surgery, kidney replacement therapy, and complications of cirrhosis. The guideline emphasizes that there are few evidence-based indications supporting the routine use of albumin to improve patient outcomes. Key findings include:

 

1 – Critical Care: Limited recommendations for using albumin in adult, pediatric, and neonatal critical care, primarily advising against its routine use for volume replacement or managing hypoalbuminemia due to low or very low certainty of evidence.

2 – Cardiovascular Surgery: No recommendations for using albumin to prime cardiovascular bypass circuits or for volume replacement due to moderate to very low certainty of evidence.

3 – Kidney Replacement Therapy: Albumin is not suggested for preventing or managing intradialytic hypotension or improving ultrafiltration due to very low certainty of evidence.

4 – Cirrhosis Complications: Some conditional recommendations for using albumin in specific scenarios like large-volume paracentesis and spontaneous bacterial peritonitis due to low certainty of evidence; however, it is generally not suggested for other complications of cirrhosis.

 

Overall, the guidelines advise a cautious approach to albumin use, highlighting the need for more robust evidence to support its broader application in clinical practice.

 

Reference (link to free full-text):

Callum J et al. (2024). Use of Intravenous Albumin: A Guideline From the International Collaboration for Transfusion Medicine Guidelines. CHEST, 2024. DOI: https://doi.org/10.1016/j.chest.2024.02.049.

 


Cluster Randomized Trial: Hyperangulated video laryngoscopy reduces intubation attempts in surgical patients – JAMA

11 May, 2024 | 13:39h | UTC

Study Design and Population: This cluster randomized multiple crossover clinical trial was conducted at a single U.S. academic hospital to compare the effectiveness of hyperangulated video laryngoscopy versus direct laryngoscopy in reducing the number of intubation attempts during surgery. The study involved 7,736 adult patients, aged 18 years or older, undergoing elective or emergent cardiac, thoracic, or vascular surgical procedures that required single-lumen endotracheal intubation for general anesthesia. The trial randomized two sets of 11 operating rooms on a weekly basis to use either video laryngoscopy or direct laryngoscopy for the initial intubation attempt from March 2021 to December 2022.

Main Findings: Hyperangulated video laryngoscopy significantly decreased the number of intubation attempts compared to direct laryngoscopy. Specifically, 1.7% of surgical procedures using video laryngoscopy required more than one intubation attempt versus 7.6% for direct laryngoscopy, with an estimated proportional odds ratio of 0.20 (95% CI, 0.14-0.28; P < .001). Furthermore, intubation failure was markedly lower with video laryngoscopy (0.27%) compared to direct laryngoscopy (4.0%). However, there was no significant difference in the rates of airway and dental injuries between the two methods.

Implications for Practice: The findings indicate that hyperangulated video laryngoscopy enhances initial intubation success and reduces the need for multiple intubation attempts in a variety of surgical settings. This suggests that video laryngoscopy could be considered a preferable technique for endotracheal intubation in the operating room, potentially improving patient outcomes and efficiency. Further research might explore the generalizability of these results to other medical centers and different patient populations.

 

Reference (link to abstract – $ for full-text):

Ruetzler, K. et al. (2024). Cluster Randomized Trial: Hyperangulated Video Laryngoscopy Reduces Intubation Attempts in Surgical Patients. JAMA, 331(15), 1279-1286. DOI: 10.1001/jama.2024.0762

 


RCT: Video laryngoscopy improves first-attempt intubation success in neonates compared to direct laryngoscopy – N Engl J Med

11 May, 2024 | 13:37h | UTC

Study Design and Population: This single-center randomized clinical trial investigated the efficacy of video laryngoscopy versus direct laryngoscopy for urgent intubation in neonates. A total of 226 neonates requiring intubation either in the delivery room or neonatal intensive care unit (NICU) were enrolled and stratified by gestational age into two groups: less than 32 weeks and 32 weeks or more. The study primarily focused on the success rate of the first intubation attempt, monitored through exhaled carbon dioxide detection.

Main Findings: The trial included 214 neonates, analyzing the success of intubation on the first attempt. Video laryngoscopy significantly outperformed direct laryngoscopy, achieving a first-attempt success rate of 74% (95% confidence interval [CI], 66 to 82) compared to 45% (95% CI, 35 to 54) in the direct laryngoscopy group. Moreover, the median number of attempts for successful intubation was lower in the video-laryngoscopy group (1 attempt, 95% CI, 1 to 1) versus the direct-laryngoscopy group (2 attempts, 95% CI, 1 to 2). Additionally, neonates in the video laryngoscopy group experienced higher median lowest oxygen saturations and heart rates during intubation.

Implications for Practice: The findings suggest that video laryngoscopy could be more effective than direct laryngoscopy for urgent neonatal intubation, particularly in increasing the likelihood of success on the first attempt. These results recommend reconsidering current intubation techniques in neonatal care settings to incorporate video laryngoscopy, potentially leading to safer and more efficient intubation processes in this vulnerable population.

 

Reference (link to abstract – $ for full-text):

Geraghty, L.E. et al. (2024). Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2402785.

 


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