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The duration of antibiotic treatment of exacerbations of COPD (ECOPD) is controversial. Serum procalcitonin (PCT) is a biomarker of bacterial infection used to identify the cause of ECOPD. We investigated whether a PCT-guided plan would allow a shorter duration of antibiotic treatment in patients with severe ECOPD. For this multicenter, randomized, non-inferiority trial, we enrolled 184 patients hospitalized with ECOPD from 18 hospitals in Italy. Patients were assigned to receive antibiotics for 10 days (standard group) or for either 3 or 10 days (PCT group). The primary outcome was the rate of ECOPD at 6 months. Having planned to recruit 400 patients, we randomized only 183: 93 in the PCT group and 90 in the standard group. Thus, the completed study was underpowered. The ECOPD rate at 6 months between PCT-guided and standard antibiotic treatment was not significant (% difference, 4.04; 90% confidence interval [CI], -7.23 to 15.31), but the CI included the non-inferiority margin of 15. In the PCT-guided group, about 50% of patients were treated for 3 days, and there was no difference in primary or secondary outcomes compared to patients treated for 10 days. Although the primary and secondary clinical outcomes were no different for patients treated for 3 or 10 days in the PCT group, the conclusion that antibiotics can be safely stopped after 3 days in patients with low serum PCT cannot be substantiated statistically. Thus, the results of this study are inconclusive regarding the noninferiority of the PCT-guided plan compared to the standard antibiotic treatment. The study was funded by Agenzia Italiana del Farmaco (AIFA-FARM58J2XH). Clinical trial registered with www.clinicaltrials.gov (NCT01125098). ClinicalTrials.gov NCT01125098.

OBJECTIVES: In a previous study on bronchoalveolar lavage fluid from rats exposed in vivo for seven days to 10 ppm nitrogen dioxide (NO2), it has been shown that there is an influx of macrophages into the airways. The present study investigated the effect of seven day exposure to 10 ppm NO2, on: (a) lung tissue inflammation and morphology; (b) airway microvascular leakage; (c) in vitro contractile response of main bronchi. METHODS: Lung tissue was studied by light microscopy, after fixing the lungs by inflation with 4% formalin at a pressure of 20 cm H2O. Microvascular leakage was measured by extravasation of Evans blue dye in the larynx, trachea, main bronchi, and intrapulmonary airways. Smooth muscle responsiveness was evaluated by concentration-responses curves to acetylcholine (10(-9)-10(-3) M), serotonin (10(-9)-10(-4) M), and voltage-response curves (12-28 V) to electrical field stimulation. RESULTS: Histology showed an increased total inflammation at the level of respiratory bronchioles and alveoli. No influx of inflammatory cells was found in the main bronchi. A loss of cilia in the epithelium of small airways and ectasia of alveolar capillaries was also found. By contrast, no alterations to microvascular permeability or modification of bronchial smooth muscle responsiveness was found. CONCLUSIONS: Subchronic exposure to 10 ppm NO2 causes airway inflammation and structural damage, but does not cause any persistent alteration to microvascular permeability or bronchial smooth muscle responsiveness in rats.

ObjectiveThe aim of the study was to describe the epidemiology and outcome of patients hospitalised during the COVID-19 pandemic in intensive cardiac care units (ICCs).DesignNon-interventional, retrospective and prospective, nationwide study.Setting109 private or public ICCs in Italy.Participants6054 consecutive patients admitted to Italian ICCs during COVID-19 pandemic.Primary and secondary outcome measuresTo obtain accurate and up-to-date information on epidemiology and outcome of patients admitted to ICCs during the COVID-19 pandemic, the impact that the COVID-19 infection may have determined on the organisational pathways and in-hospital management of the various clinical conditions being admitted to ICCs.ResultsAcute coronary syndromes were the most frequent ICC discharge diagnoses followed by heart failure and hypokinetic arrhythmias. The prevalence of COVID-19 positivity was approximately 3%. Most patients with a COVID-19 diagnosis at discharge (52%) arrived to ICC from other wards, in particular 22% from non-cardiology ICCs. The overall mortality was 4.2% during ICC and 5.8% during hospital stay. The cause of in-hospital death was cardiac in 74.4% of the cases, non-cardiovascular in 13.5%, vascular in 5.8% and related to COVID-19 in 6.3% of the patients.ConclusionsThis study provides a unique nationwide picture of current ICC care during COVID-19 pandemic.Trial registration numberNCT04744415.

To investigate whether the addition of intrapulmonary percussive ventilation to the usual chest physiotherapy improves gas exchange and lung mechanics in tracheostomized patients. Randomized multicenter trial in two weaning centers in northern Italy. 46 tracheostomized patients (age 70 +/- 7 years, 28 men, arterial blood pH 7.436 +/- 0.06, PaO(2)/FIO(2) 238 +/- 46) weaned from mechanical ventilation. Patients were assigned to two treatment groups performing chest physiotherapy (control), or percussive ventilation (IMP2 Breas, Sweden) 10 min twice/day in addition to chest physiotherapy (intervention). Arterial blood gases, PaO(2)/FIO(2) ratio, and maximal expiratory pressure were assessed every 5th day for 15 day. Treatment complications that showed up in 1 month of follow-up were recorded. At 15 days the intervention group had a significantly better PaO(2)/FIO(2) ratio and higher maximal expiratory pressure; after follow-up this group also had a lower incidence of pneumonia. The addition of percussive ventilation to the usual chest physiotherapy regimen in tracheostomized patients improves gas exchange and expiratory muscle performance and reduces the incidence of pneumonia.

Atrial fibrillation (AF) accounts for 2% of the total presentations to the emergency department (ED) and represents the most frequent arrhythmic cause for hospitalization. It steadily increases the risk of thromboembolic events and is often associated with several comorbidities that negatively affect patient's quality of life and prognosis. AF has a considerable on healthcare resources, making the promotion of an adequate and coordinated management of this arrhythmia necessary in order to avoid clinical complications and to implement the adoption of appropriate technological and pharmacological treatment options. AF management varies across regions and hospitals and there is also heterogeneity in the use of anticoagulation and electric cardioversion, with limited use of direct oral anticoagulants. The ED represents the first access point for early management of patients with AF. The appropriate management of this arrhythmia in the acute setting has a great impact on improving patient's quality of life and outcomes as well as on rationalization of the financial resources related to the clinical course of AF. Therefore, physicians should provide a well-structured clinical and diagnostic pathway for patients with AF who are admitted to the ED. This should be based on a tight and propositional collaboration among several specialists, i.e. the ED physician, cardiologist, internal medicine physician, anesthesiologist. The aim of this ANMCO-SIMEU consensus document is to provide shared recommendations for promoting an integrated, accurate, and up-to-date management of patients with AF admitted to the ED or Cardiology Department, so as to make it homogeneous across the national territory.

Abstract Background: We compared the efficacy and safety of formoterol given by a pressurized metered-dose inhaler (pMDI) (Atimos®, Chiesi Farmaceutici, Italy), using a chlorine-free hydrofluoroalkane (HFA-134a) propellant developed to provide stable and uniform dose delivery (Modulite™, Chiesi Farmaceutici, Italy), with formoterol by dry powder inhaler (DPI) (Foradil® Aerolizer®, Novartis Pharmaceuticals) and placebo, in reducing airflow obstruction and lung hyperinflation, in moderate-to-severe, partially reversible chronic obstructive pulmonary disease (COPD). Methods: Forty-eight patients were randomized to a 1-week, double-blind, double-dummy, three-period crossover study with 12 μg b.i.d. of formoterol given by pMDI or DPI, or placebo. Spirometry, specific airway conductance, and lung volumes were measured at the beginning and at the end of each treatment period from predose to 4 h postdose. A 6-min walking test was carried out 4 h after the first and the last dose, with dyspnea assessed by Borg scale. Safety was assessed through adverse events monitoring electrocardiography and vital signs. Results: The two formulations of formoterol were significantly superior to placebo but not different from each other in increasing 1-sec forced expiratory volume, specific airway conductance, inspiratory capacity, and inspiratory-to-total lung capacity ratio. The two active treatments were also equivalent and superior to placebo in reducing dyspnea at rest and on exertion. No differences in terms of safety between the two active forms and placebo were detected. Conclusions: Formoterol given with chlorine-free pMDI was equivalent to DPI in reducing airway obstruction and lung hyperinflation in COPD patients. Both formoterol formulations confirmed the good safety profile similar to placebo.

La fibrillazione atriale (FA) è responsabile del 2% circa degli accessi al Dipartimento di Emergenza-Urgenza (DEU) e rappresenta la più frequente causa aritmica di ricovero ospedaliero. La FA aumenta notevolmente il rischio di eventi tromboembolici e spesso si associa ad una serie di comorbilità che impattano negativamente sulla qualità di vita e sulla prognosi dei pazienti. La FA, inoltre, ha un notevole impatto socio-economico, che impone un’adeguata e coordinata gestione di tale aritmia per evitare gravi complicanze e consentire un appropriato utilizzo di risorse tecnologiche e farmacologiche. L’approccio a tale aritmia è abbastanza disomogeneo nelle varie realtà regionali ed ospedaliere; diverso l’utilizzo dei farmaci anticoagulanti e ancora poco diffuso l’utilizzo precoce degli anticoagulanti orali diretti, diverso il ricorso alla cardioversione elettrica. Il DEU rappresenta spesso il punto di primo accesso alle cure per pazienti con FA. La corretta gestione in acuto di tale aritmia ha un notevole impatto non solo per la qualità di vita del paziente e per il suo outcome clinico, ma anche per la razionalizzazione e la corretta gestione delle risorse impiegate. Ne deriva la necessità di rendere univoco e ben definito il percorso clinico-diagnostico del paziente che afferisce al DEU con FA, basato su di una stretta collaborazione tra differenti figure professionali – il medico dell’emergenza-urgenza, il cardiologo, l’internista e l’anestesista-rianimatore. Lo scopo di questo documento di consenso, elaborato dalle società scientifiche ANMCO e SIMEU, è di proporre raccomandazioni condivise tra i Dipartimenti dell’Emergenza e delle Malattie Cardiovascolari per una gestione integrata, puntuale e aggiornata del paziente affetto da FA, per migliorare e rendere omogenea su tutto il territorio nazionale la gestione dei pazienti che giungono in Pronto Soccorso per e con FA.