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Competing Interests: Competing interestsThe authors declare no competing interests.

Competing Interests: Competing interestsThe authors declare no competing interests.

Background: Health-related quality of life (HRQoL) impairment is often reported among COVID-19 ICU survivors, and little is known about their long-term outcomes. We evaluated the HRQoL trajectories between 3 months and 1 year after ICU discharge, the factors influencing these trajectories and the presence of clusters of HRQoL profiles in a population of COVID-19 patients who underwent invasive mechanical ventilation (IMV). Moreover, pathophysiological correlations of residual dyspnea were tested., Methods: We followed up 178 survivors from 16 Italian ICUs up to one year after ICU discharge. HRQoL was investigated through the 15D instrument. Available pulmonary function tests (PFTs) and chest CT scans at 1 year were also collected. A linear mixed-effects model was adopted to identify factors associated with different HRQoL trajectories and a two-step cluster analysis was performed to identify HRQoL clusters., Results: We found that HRQoL increased during the study period, especially for the significant increase of the physical dimensions, while the mental dimensions and dyspnea remained substantially unchanged. Four main 15D profiles were identified: full recovery (47.2%), bad recovery (5.1%) and two partial recovery clusters with mostly physical (9.6%) or mental (38.2%) dimensions affected. Gender, duration of IMV and number of comorbidities significantly influenced HRQoL trajectories. Persistent dyspnea was reported in 58.4% of patients, and weakly, but significantly, correlated with both DLCO and length of IMV., Conclusions: HRQoL impairment is frequent 1 year after ICU discharge, and the lowest recovery is found in the mental dimensions. Persistent dyspnea is often reported and weakly correlated with PFTs alterations., Trial Registration: NCT04411459., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Background: In recent years, many studies showed that the Trauma Mortality Probability Model (TMPM-ICD-9) had better calibration compared to other ICD-9-based models and to the ones based to the Abbreviated Injury Scale (AIS). The study aims to assess the validity of TMPM-ICD-9 in predicting injury severity in an Italian region and, through this model, to assess the performances of the Trauma Systems SIAT Romagna., Methods: Administrative data of trauma patients admitted in the Trauma System of SIAT Romagna, in Northern Italy, from 2014 to 2018 were obtained. The XISS, an indirect indicator of Injury Severity Score (ISS) and the TMPM-POD (Probability of Death) were calculated from ICD-9-CM codes. Only patients with XISS > 15 were included. Student t-test, Mann-Whitney test and Chi-square test were used for univariate analyses, while logistic regression for multivariate analyses., Results: 3907 trauma patients with XISS > 15 were included. The Hub hospital (HUB) received 47.1% of these patients. Patients treated in HUB had higher TMPM-POD than in SPOKE + PST (mean TMPM-POD ± SD: HUB 0.093 ± 0.091, SPOKE + PST 0.082 ± 0.90, p < 0.027), but only age and sex were significant risk factors for centralization at multivariate analyses. Higher age (73.1 ± 21.2 vs 66.9 ± 21.2, p < 0.001), higher XISS (16(9) vs 16(4), p < 0.001) and higher TMPM-POD (0.15 ± 0.14 vs 0.08 ± 0.08, p < 0.001) resulted significant risk factors for mortality at multivariate analysis. Lower age, higher XISS and lower Trauma Centers (TC) level were significant risk factors for splenectomy at multivariate analysis. The splenectomy rate was 1.3% in HUB and of 2.2% in SPOKE + PST (Risk Ratio = 0.4, p = 0.002)., Conclusions: Present analysis proved the validity of TMPM-ICD-9 in predicting mortality of trauma patients in an Italian region. Furthermore, the usefulness of data extracted from an administrative database to assess the performance of a TS and the importance of an adequate centralization process have emerged. Even with a higher TMPM-POD and with the same mortality rate, HUB showed a higher spleen salvage rate compared to SPOKE + PST. However, thanks to this model, an improvable centralization process in SIAT Romagna was found in the study period. Probably, an enhanced centralization would have improved the spleen salvage rate, which is an important quality indicator in the evaluation of the performance of the TS., (© 2021. Società Italiana di Medicina Interna (SIMI).)

Purpose: The onset of the coronavirus disease 19 (COVID-19) pandemic in Italy induced a dramatic increase in the need for intensive care unit (ICU) beds for a large proportion of patients affected by COVID-19-related acute respiratory distress syndrome (ARDS). The aim of the present study was to describe the health-related quality of life (HRQoL) at 90 days after ICU discharge in a cohort of COVID-19 patients undergoing invasive mechanical ventilation and to compare it with an age and sex-matched sample from the general Italian and Finnish populations. Moreover, the possible associations between clinical, demographic, social factors, and HRQoL were investigated., Methods: COVID-19 ARDS survivors from 16 participating ICUs were followed up until 90 days after ICU discharge and the HRQoL was evaluated with the 15D instrument. A parallel cohort of age and sex-matched Italian population from the same geographic areas was interviewed and a third group of matched Finnish population was extracted from the Finnish 2011 National Health survey. A linear regression analysis was performed to evaluate potential associations between the evaluated factors and HRQoL., Results: 205 patients answered to the questionnaire. HRQoL of the COVID-19 ARDS patients was significantly lower than the matched populations in both physical and mental dimensions. Age, sex, number of comorbidities, ARDS class, duration of invasive mechanical ventilation, and occupational status were found to be significant determinants of the 90 days HRQoL. Clinical severity at ICU admission was poorly correlated to HRQoL., Conclusion: COVID-19-related ARDS survivors at 90 days after ICU discharge present a significant reduction both on physical and psychological dimensions of HRQoL measured with the 15D instrument., Trial Registration: NCT04411459., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Background: Prone positioning (PP) has been used to improve oxygenation in patients affected by the SARS-CoV-2 disease (COVID-19). Several mechanisms, including lung recruitment and better lung ventilation/perfusion matching, make a relevant rational for using PP. However, not all patients maintain the oxygenation improvement after returning to supine position. Nevertheless, no evidence exists that a sustained oxygenation response after PP is associated to outcome in mechanically ventilated COVID-19 patients. We analyzed data from 191 patients affected by COVID-19-related acute respiratory distress syndrome undergoing PP for clinical reasons. Clinical history, severity scores and respiratory mechanics were analyzed. Patients were classified as responders (≥ median PaO 2 /FiO 2 variation) or non-responders (< median PaO 2 /FiO 2 variation) based on the PaO 2 /FiO 2 percentage change between pre-proning and 1 to 3 h after re-supination in the first prone positioning session. Differences among the groups in physiological variables, complication rates and outcome were evaluated. A competing risk regression analysis was conducted to evaluate if PaO 2 /FiO 2 response after the first pronation cycle was associated to liberation from mechanical ventilation., Results: The median PaO 2 /FiO 2 variation after the first PP cycle was 49 [19-100%] and no differences were found in demographics, comorbidities, ventilatory treatment and PaO 2 /FiO 2 before PP between responders (96/191) and non-responders (95/191). Despite no differences in ICU length of stay, non-responders had a higher rate of tracheostomy (70.5% vs 47.9, P = 0.008) and mortality (53.7% vs 33.3%, P = 0.006), as compared to responders. Moreover, oxygenation response after the first PP was independently associated to liberation from mechanical ventilation at 28 days and was increasingly higher being higher the oxygenation response to PP., Conclusions: Sustained oxygenation improvement after first PP session is independently associated to improved survival and reduced duration of mechanical ventilation in critically ill COVID-19 patients.

Quality Problem or Issue: The on-going COVID-19 pandemic may cause the collapse of healthcare systems because of unprecedented hospitalization rates., Initial Assessment: A total of 8.2 individuals per 1000 inhabitants have been diagnosed with COVID-19 in our province. The hospital predisposed 110 beds for COVID-19 patients: on the day of the local peak, 90% of them were occupied and intensive care unit (ICU) faced unprecedented admission rates, fearing system collapse., Choice of Solution: Instead of increasing the number of ICU beds, the creation of a step-down unit (SDU) close to the ICU was preferred: the aim was to safely improve the transfer of patients and to relieve ICU from the risk of overload., Implementation: A nine-bed SDU was created next to the ICU, led by intensivists and ICU nurses, with adequate personal protective equipment, monitoring systems and ventilators for respiratory support when needed. A second six-bed SDU was also created., Evaluation: Patients were clinically comparable to those of most reports from Western Countries now available in the literature. ICU never needed supernumerary beds, no patient died in the SDU, and there was no waiting time for ICU admission of critical patients. SDU has been affordable from human resources, safety and economic points of view., Lessons Learned: COVID-19 is like an enduring mass casualty incident. Solutions tailored on local epidemiology and available resources should be implemented to preserve the efficiency and adaptability of our institutions and provide the adequate sanitary response., (© The Author(s) 2020. Published by Oxford University Press on behalf of International Society for Quality in Health Care.)

Background: A large proportion of patients with coronavirus disease 2019 (COVID-19) develop severe respiratory failure requiring admission to the intensive care unit (ICU) and about 80% of them need mechanical ventilation (MV). These patients show great complexity due to multiple organ involvement and a dynamic evolution over time; moreover, few information is available about the risk factors that may contribute to increase the time course of mechanical ventilation.The primary objective of this study is to investigate the risk factors associated with the inability to liberate COVID-19 patients from mechanical ventilation. Due to the complex evolution of the disease, we analyzed both pulmonary variables and occurrence of non-pulmonary complications during mechanical ventilation. The secondary objective of this study was the evaluation of risk factors for ICU mortality., Methods: This multicenter prospective observational study enrolled 391 patients from fifteen COVID-19 dedicated Italian ICUs which underwent invasive mechanical ventilation for COVID-19 pneumonia. Clinical and laboratory data, ventilator parameters, occurrence of organ dysfunction, and outcome were recorded. The primary outcome measure was 28 days ventilator-free days and the liberation from MV at 28 days was studied by performing a competing risks regression model on data, according to the method of Fine and Gray; the event death was considered as a competing risk., Results: Liberation from mechanical ventilation was achieved in 53.2% of the patients (208/391). Competing risks analysis, considering death as a competing event, demonstrated a decreased sub-hazard ratio for liberation from mechanical ventilation (MV) with increasing age and SOFA score at ICU admission, low values of PaO 2 /FiO 2 ratio during the first 5 days of MV, respiratory system compliance (C RS ) lower than 40 mL/cmH 2 O during the first 5 days of MV, need for renal replacement therapy (RRT), late-onset ventilator-associated pneumonia (VAP), and cardiovascular complications.ICU mortality during the observation period was 36.1% (141/391). Similar results were obtained by the multivariate logistic regression analysis using mortality as a dependent variable., Conclusions: Age, SOFA score at ICU admission, C RS , PaO 2 /FiO 2 , renal and cardiovascular complications, and late-onset VAP were all independent risk factors for prolonged mechanical ventilation in patients with COVID-19., Trial Registration: NCT04411459., Competing Interests: Competing interestsThe authors have no conflict of interest to declare., (© The Author(s) 2020.)

Background: Major trauma patients experience a 20% mortality rate overall, and many survivors remain permanently disabled.In order to monitor the quality of trauma care in the Trauma System, outcomes assessment is essential. Quality indicators on outcome can be expressed as quality of life, functional outcome, and others.The trauma follow-up system was created within the Romagna Trauma System (Italy) in order to monitor the trauma network and assess its long-term outcomes.The aim of this paper is firstly to evaluate the existence of correlations between epidemiological data, severity of injury, and clinical assessment characterizing the acute phase and the long-term outcomes in trauma patients and secondly, to explore the association between outcome variables have been modified., Methods: We conducted a cross-sectional study over a 10-year period, including patients with severe trauma who survived and were discharged from the intensive care unit. The outcome measures were assessed with the use of the Extended Glasgow Outcome Scale and the Euro Quality of Life scale 5 dimension.Demographic data and clinical severity descriptors versus functional outcome were tested in a binary logistic regression model., Results: In all, 428 major trauma patients participated in the study. At 1 year, 50.8% of trauma patients included had a good recovery and 49.2% had some degree of disability. The median value of quality of life was 0.725.At the multivariate analysis, variables showing significant impact on functional outcome were age ( p = 0.052, OR 1.025), injury severity score ( p = 0.001, OR 1.025), and Glasgow coma scale ≤ 8 ( p = 0.001, OR 3.509)The Spearman's Rank correlation coefficient showed a strong correlation between the global level of function variables and quality of life at one year (Spearman's Rho Correlation Coefficient 0.760 ( p < 0.0001))., Conclusions: Increased age, increased injury severity score, and severe traumatic brain injury are predictors of long-term disability.Most of these trauma patients show impairments that affect not only the level of functional state but also the quality of life. The degree of functional independence has the greatest positive impact on quality of life.According to our results, after the recovery a prompt recognition of physical and psychological problems with systematic follow-up screening programs can help patients and doctors in defining specific therapeutic-rehabilitation pathways tailored to meet individual requirements., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s). 2020.)

Background: This study was conceived to provide systematic data about lung mechanics during early phases of CoVID-19 pneumonia, as long as to explore its variations during prone positioning., Methods: We enrolled four patients hospitalized in the Intensive Care Unit of "M. Bufalini" hospital, Cesena (Italy); after the positioning of an esophageal balloon, we measured mechanical power, respiratory system and transpulmonary parameters and arterial blood gases every 6 hours, just before decubitus change and 1 hour after prono-supination., Results: Both respiratory system and transpulmonary compliance and driving pressure confirmed the pseudo-normal respiratory mechanics of early CoVID-19 pneumonia (respectively, C RS 40.8 ml/cmH 2 O and DP RS 9.7 cmH 2 O; C L 53.1 ml/cmH 2 O and DP L 7.9 cmH 2 O). Interestingly, prone positioning involved a worsening in respiratory mechanical properties throughout time (C RS,SUP 56.3 ml/cmH 2 O and C RS,PR 41.5 ml/cmH 2 O - P 0.37; C L,SUP 80.8 ml/cmH 2 O and C L,PR 53.2 ml/cmH 2 O - P 0.23)., Conclusions: Despite the severe ARDS pattern, respiratory system and lung mechanical properties during CoVID-19 pneumonia are pseudo-normal and tend to worsen during pronation., Trial Registration: Restrospectively registered., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Organ retrieved from donors after circulatory deaths (DCD) is vulnerable of the effects of warm ischemia with important consequence on graft survival and posttransplant outcome. Preservation techniques, such as normothermic regional perfusion (NRP), can be used to reduce the effects of the cardiac arrest and to generate a continuous flow to the organs, resulting in a better preservation of the organs for transplantation. However, technical complications may occur during NRP which can compromise the retrieve of donors' organs. We present a case report of a technical complication arisen during an NRP for DCD. During the extracorporeal circuit, we observed a dramatical decrease in the blood flow with excessive negative inlet pressure. It was because of a later recognized venous cannula malposition. In fact, we did not perform the radiological control for wire position. As a consequence, our clinical practice was modified. Currently, a radiological control of the wire is performed before the insertion of the catheter. Even if the donation was accomplished successfully, we reckon that it is fundamental to describe the technical issue that may occur during perfusion technique in order to improve the safety and the effectiveness of these procedures.

[This corrects the article DOI: 10.21037/jtd.2017.06.12.].

Introduction: Hemorrhage is the principal cause of death in the first few hours following severe injury. Coagulopathy is a frequent complication of critical bleeding. A network of Italian trauma centers recently developed a protocol to prevent and treat trauma-induced coagulopathy. A pre-post cohort multicenter study was conducted to assess the impact of the early coagulation support (ECS) protocol on blood products consumption, mortality and treatment costs., Methods: We prospectively collected data from all severely injured patients (Injury Severity Score (ISS) >15) admitted to two trauma centers in 2013 and compared these findings with the data for 2011. Patients transfused with at least 3 units of packed red blood cells (PRBCs) within 24 hours of an accident were included in the study. In 2011, patients with significant hemorrhaging were treated with early administration of plasma with the aim of achieving a high (≥1:2) plasma-to-PRBC ratio. In 2013, the ECS protocol was the treatment strategy. Outcome data, blood product consumption and treatment costs were compared between the two periods., Results: The two groups were well matched for demographics, injury severity (ISS: 32.9 in 2011 versus 33.6 in 2013) and clinical and laboratory data on admission. In 2013, a 40% overall reduction in PRBCs was observed, together with a 65% reduction in plasma and a 52% reduction in platelets. Patients in the ECS group received fewer blood products: 6.51 units of PRBCs versus 8.14 units. Plasma transfusions decreased from 8.98 units to 4.21 units (P <0.05), and platelets fell from 4.14 units to 2.53 units (P <0.05). Mortality in 2013 was 13.5% versus 20% in 2011 (13 versus 26 hospital deaths, respectively) (nonsignificant). When costs for blood components, factors and point-of-care tests were compared, a €76,340 saving in 2013 versus 2011 (23%) was recorded., Conclusions: The introduction of the ECS protocol in two Italian trauma centers was associated with a marked reduction in blood product consumption, reaching statistical significance for plasma and platelets, and with a non-significant trend toward a reduction in early and 28-day mortality. The overall costs for transfusion and coagulation support (including point-of-care tests) decreased by 23% between 2011 and 2013.