Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).
The gold standard for RA will be achieved after overcoming a number of limitations by a more extensive use of ultrasonography, by combining general and regional anaesthesia, including conscious anaesthesia, by defining the appropriate volume, concentration and dosage of local agents and by addition of adjuvants.
Background: One-lung ventilation (OLV) in thoracic anesthesia is required to provide good surgical exposure. OLV is commonly achieved through a double lumen tube (DLT) or a bronchial blocker (BB). Malposition is a relevant issue related to these devices use. No prospective studies with adequately large sample size have been performed to evaluate the malposition rate of DLTs and BBs. Methods: A total of 2,127 patients requiring OLV during thoracic surgery were enrolled. The aim of this multicenter prospective observational study performed across 26 academic and community hospitals is to evaluate intraoperative malposition rate of DLTs and BBs. We also aim to assess: which device is the most used to achieve OLV, the frequency of bronchoscope (BRO) use, the incidence rate of desaturation during OLV and the role of other factors that can correlate to this event, and incidence of difficult airway. Results: Malposition rate for DLTs was 14%, for BBs 33%. DLTs were used in 95% of patients and BBs in 5%. Mean positioning time was shorter for DLT than BB (156±230 vs. 321±290 s). BRO was used in 54% of patients to check the correct positioning of the DLT. Desaturation occurred in 20% of all cases during OLV achieved through a DLT. Predicting factors of desaturation were dislocation (OR 2.03) and big size of DLT (OR 1.15). BRO use (OR 0.69) and left surgical side (OR 0.41) proved to be protective factors. Difficult
IntroductionOn 6 April 2009, at 03:32 local time, an Mw 6.3 earthquake hit the Abruzzi region of central Italy causing widespread damage in the City of L Aquila and its nearby villages. The earthquake caused 308 casualties and over 1,500 injuries, displaced more than 25,000 people and induced significant damage to more than 10,000 buildings in the L'Aquila region.ObjectivesThis observational retrospective study evaluated the prevalence and drug treatment of pain in the five weeks following the L'Aquila earthquake (April 6, 2009).Methods 958 triage documents were analysed for patients pain severity, pain type, and treatment efficacy.ResultsA third of pain patients reported pain with a prevalence of 34.6%. More than half of pain patients reported severe pain (58.8%). Analgesic agents were limited to available drugs: anti-inflammatory agents, paracetamol, and weak opioids. Reduction in verbal numerical pain scores within the first 24 hours after treatment was achieved with the medications at hand. Pain prevalence and characterization exhibited a biphasic pattern with acute pain syndromes owing to trauma occurring in the first 15 days after the earthquake; traumatic pain then decreased and re-surged at around week five, owing to rebuilding efforts. In the second through fourth week, reports of pain occurred mainly owing to relapses of chronic conditions.ConclusionsThis study indicates that pain is prevalent during natural disasters, may exhibit a discernible pattern over the weeks following the event, and current drug treatments in this region may be adequate for emergency situations.
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