Assessment of cephalometric parameters and correlation with the severity of the obstructive sleep apnea syndrome.

BACKGROUND: In individuals diagnosed with obstructive sleep apnea syndrome (OSAS), variations in craniofacial structure have been inconsistently documented, showing differing degrees of alteration between obese and nonobese patients. In addition, sleep disturbance has also been shown to induce disequilibrium in this population of patients. This pilot observational study aimed to assess craniofacial values in obese and nonobese subpopulations of patients with OSAS and their correlation and association with the severity of OSAS. We also assessed whether OSAS patients are characterized by an impaired equilibrium in relation to and associated with the severity of OSAS. METHODS: We included all consecutive adult patients with OSAS. Through cephalometry, we assessed the upper (UPa-UPp) and lower (LPa-LPp) pharynx diameters, superior anterior facial height (Sor-ANS), anterior facial height (ANS-Me), anterior vertical dimension (Sor-Me), posterior facial height (S-Go) and craniovertebral angle (CVA). Furthermore, we analyzed postural equilibrium through a stabilometric examination. RESULTS: Forty consecutive OSAS patients (45% female with a mean age of 56 ± 8.2 years) were included. The subgroup of nonobese patients had a reduced UPa-UPp (p = 0.02). Cephalometric measurements were correlated with the severity of OSAS in nonobese patients, whereas only Sor-ANS was correlated with the severity of OSAS in the obese subpopulation. In the overall population, altered craniofacial values are associated with severe OSAS. Although there are differences in equilibrium between obese and nonobese OSAS patients, the stabilometric measurements were not correlated or associated with OSAS severity. CONCLUSION: Altered craniofacial values and compromised equilibrium in OSAS patients are linked to OSAS severity. Therefore, the management of OSAS should be tailored not only to weight management but also to craniofacial and postural rehabilitation to enhance patient outcomes.

Effects of inhaled beclomethasone dipropionate/formoterol fumarate/glycopyrronium on diaphragmatic workload and lung function in uncontrolled asthma: a case report.

Beclomethasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) single inhaler extrafine triple therapy is effective for the treatment of uncontrolled asthma. Nevertheless, there is a lack of data about the use of diaphragmatic ultrasonography to monitor adult asthmatics while they are receiving inhaled treatment. We took into consideration a 78-year-old woman complaining of asthma, treated with inhaled corticosteroid/long-acting ß2-adrenergic agonist (ICS/LABA), characterized by an asthma control questionnaire-5 (ACQ-5) score and a lung function test suggestive of uncontrolled asthma. Moreover, a diaphragmatic ultrasound showed signs of high diaphragm workload. Because of these findings, we proposed to our patient a shift toward triple inhaled therapy with BDP/FF/G, and she underwent a second evaluation after 7 days of treatment. Improvements in the diaphragmatic ultrasound parameters, lung function test, and ACQ-5 score were found. In particular, we detected a reduction of thickening fraction (TF), and a normalization of the other diaphragmatic measures, indicative of a decrease in diaphragmatic workload. To our knowledge, this is the first literature report showing concomitant improvements of both lung function tests and diaphragmatic ultrasonography parameters, observed in an adult patient with uncontrolled asthma after short-term treatment with the single inhaler triple therapy BDP/FF/G.

Articulating Video Stylet Compared to Other Techniques for Endotracheal Intubation in Normal Airways: A Simulation Study in Consultants with No Prior Experience.

Simulation for airway management allows for acquaintance with new devices and techniques. Endotracheal intubation (ETI), most commonly performed with direct laryngoscopy (DL) or video laryngoscopy (VLS), can be achieved also with combined laryngo-bronchoscopy intubation (CLBI). Finally, an articulating video stylet (ProVu) has been recently introduced. A single-center observational cross-sectional study was performed in a normal simulated airway scenario comparing DL, VLS-Glidescope, VLS-McGrath, CLBI and ProVu regarding the success rate (SR) and corrected time-to-intubation (cTTI, which accounts for the SR). Up to three attempts/device were allowed (maximum of 60 s each). Forty-two consultants with no experience with ProVu participated (15 ± 9 years after training completion). The DL was significantly faster (cTTI) than all other devices (p = 0.033 vs. VLSs, and p < 0.001 for CLBI and Provu), no differences were seen between the two VLSs (p = 0.775), and the VLSs were faster than CLBI and ProVu. Provu had a faster cTTI than CLBI (p = 0.004). The DL and VLSs showed similar SRs, and all the laryngoscopes had a higher SR than CLBI and ProVu at the first attempt. However, by the third attempt, the SR was not different between the DL/VLSs and ProVu (p = 0.241/p = 0.616); ProVu was superior to CLBI (p = 0.038). In consultants with no prior experience, ProVu shows encouraging results compared to DL/VLSs under simulated normal airway circumstances and further studies are warranted.

COVID-19-associated pulmonary aspergillosis in intensive care unit: A real-life experience.

Since 2020, cases of COVID-19-associated pulmonary aspergillosis (CAPA) have been frequently described, representing an important cause of mortality, especially among patients admitted to intensive care unit (ICU). A predisposition to invasive infection caused by Aspergillus spp. in SARS-CoV-2 infected patients can be ascribed either to the direct viral-mediated damage of the respiratory epithelium or to the dysregulated immunity associated with COVID-19. In this case series we have collected the clinical, laboratory and radiological data of 10 patients admitted to the ICU with diagnosis of probable CAPA, according to the recent expert consensus statement, from March 2020 to December 2022 in the Teaching Hospital of Catanzaro in Italy. Overall, 249 patients were admitted to the COVID-19-ICU from March 2020 to December 2022; out of these, 4% developed a probable CAPA. Most of patients were male with a mean age of 62 years. Only two patients had an underlying immunocompromising condition. The observed mortality was 70%. In our institution, all COVID-19 patients requiring invasive mechanical ventilation systematically underwent bronchoscopy with bronchoalveolar lavage for an early evaluation of bacterial and/or fungal co- or super-infections, including galactomannan test. Patients were re-evaluated by an infectious diseases consultant team every 24-48 hours and the galactomannan test was systematically repeated based on patient's clinical course. Even though the numbers in this study are very small, we report our experience about the role of early diagnosis and careful choice of antifungal therapy, considering the fragility of these patients, and its relationship with outcomes. Despite a systemic approach allowing early diagnosis and initiation of anti-fungal therapy, the mortality rate turned out to be very high (70%).

Non-Invasive Monitoring during Caesarean Delivery: Prevalence of Hypotension and Impact on the Newborn.

BACKGROUND: The aim of our study was to investigate the prevalence of perioperative hypotension after spinal anesthesia for cesarean section using non-invasive continuous hemodynamic monitoring and its correlation with neonatal well-being. METHODS: We included 145 patients. Spinal anesthesia was performed with a combination of hyperbaric bupivacaine 0.5% (according to a weight/height scheme) and fentanyl 20 µg. Hypotension was defined as a mean arterial pressure (MAP) < 65 mmHg or <60 mmHg. We also evaluated the impact of hypotension on neonatal well-being. RESULTS: Perioperative maternal hypotension occurred in 54.5% of cases considering a MAP < 65 mmHg and in 42.1% with the more conservative cut-off (<60 mmHg). Severe neonatal acidosis occurred in 1.4% of neonates, while an Apgar score ≥ 9 was observed in 95.9% at 1 min and 100% at 5 min. CONCLUSIONS: Continuous non-invasive hemodynamic monitoring allowed an early detection of maternal hypotension leading to a prompt treatment with satisfactory results considering neonatal well-being.

Effects of High-Flow Nasal Cannula on Right Heart Dysfunction in Patients with Acute-on-Chronic Respiratory Failure and Pulmonary Hypertension.

High-flow nasal cannula (HFNC) has several benefits in patients affected by different forms of acute respiratory failure, based on its own mechanisms. We postulated that HFNC may have some advantages over conventional oxygen therapy (COT) on the heart function in patients with acute-on-chronic respiratory failure with concomitant pulmonary hypertension (PH). We therefore designed this retrospective observational study to assess if HFNC improves the right and left ventricle functions and morphologies, arterial blood gases (ABGs), and patients' dyspnea, compared to COT. We enrolled 17 hospitalized patients receiving HFNC, matched with 17 patients receiving COT. Echocardiographic evaluation was performed at the time of admission (baseline) and 10 days after (T10). HFNC showed significant improvements in right ventricular morphology and function, and a reduction in sPAP. However, there were no significant changes in the left heart measurements with HFNC application. Conversely, COT did not lead to any modifications in echocardiographic measurements. In both groups, oxygenation significantly improved from baseline to T10 (in the HFNC group, from 155 ± 47 to 204 ± 61 mmHg while in the COT group, from 157 ± 27 to 207 ± 27 mmHg; p < 0.0001 for both comparisons). In conclusion, these data suggest an improvement of oxygenation with both treatments; however, only HFNC was able to improve the right ventricular morphology and function after 10 days from the beginning of treatment in a small cohort of patients with acute-on-chronic respiratory failure with PH.

The Impact of an Intensive Care Diary on the Psychological Well-Being of Patients and Their Family Members: Longitudinal Study Protocol.

BACKGROUND: Thanks to medical and technological advancements, an increasing number of individuals survive admission to intensive care units. However, survivors often experience negative outcomes, including physical impairments and alterations in mental health. Anxiety, depression, cognitive impairments, post-traumatic stress disorders, and functional disorders are known collectively as post-intensive care syndrome (PICS). Among the key triggering factors of this syndrome, memory impairment appears to play a significant role. AIMS: This study aims to evaluate the impact of an intensive care diary on the psychological well-being of patients and their relatives after discharge from the ICU. DESIGN: Prospective observational study. EXPECTED RESULTS: The results of this study evaluate the impact of an ICU diary on the quality of life of ICU survivors and their family members.

High dose esomeprazole as an anti-inflammatory agent in sepsis: Protocol for a randomized controlled trial.

BACKGROUND: Sepsis is caused by dysregulated immune responses due to infection and still presents high mortality rate and limited efficacious therapies, apart from antibiotics. Recent evidence suggests that very high dose proton pump inhibitors might regulate major sepsis mediators' secretion by monocytes, which might attenuate excessive host reactions and improve clinical outcomes. This effect is obtained with doses which are approximately 50 times higher than prophylactic esomeprazole single daily administration and 17 times higher than the cumulative dose of a three day prophylaxis. We aim to perform a randomized trial to investigate if high dose esomeprazole reduces organ dysfunction in patients with sepsis or septic shock. METHODS: This study, called PPI-SEPSIS, is a multicenter, randomized, double blind, placebo-controlled clinical trial on critically ill septic patients admitted to the emergency department or intensive care unit. A total of 300 patients will be randomized to receive high dose esomeprazole (80 mg bolus followed by 12 mg/h for 72 h and a second 80 mg bolus 12 h after the first one) or equivolume placebo (sodium chloride 0.9%), with 1:1 allocation. The primary endpoint of the study will be mean daily Sequential Organ Failure Assessment (SOFA) score over 10 days. Secondary outcomes will include antibiotic-free days, single organ failure severity, intensive care unit-free days at day 28, and mortality. DISCUSSION: This trial aims to test the efficacy of high dose esomeprazole to reduce acute organ dysfunction in patients with septic shock. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov with the trial identification NCT03452865 in March 2018.

Continuous vs Intermittent Meropenem Administration in Critically Ill Patients With Sepsis: The MERCY Randomized Clinical Trial.

Importance: Meropenem is a widely prescribed ß-lactam antibiotic. Meropenem exhibits maximum pharmacodynamic efficacy when given by continuous infusion to deliver constant drug levels above the minimal inhibitory concentration. Compared with intermittent administration, continuous administration of meropenem may improve clinical outcomes. Objective: To determine whether continuous administration of meropenem reduces a composite of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria compared with intermittent administration in critically ill patients with sepsis. Design, Setting, and Participants: A double-blind, randomized clinical trial enrolling critically ill patients with sepsis or septic shock who had been prescribed meropenem by their treating clinicians at 31 intensive care units of 26 hospitals in 4 countries (Croatia, Italy, Kazakhstan, and Russia). Patients were enrolled between June 5, 2018, and August 9, 2022, and the final 90-day follow-up was completed in November 2022. Interventions: Patients were randomized to receive an equal dose of the antibiotic meropenem by either continuous administration (n = 303) or intermittent administration (n = 304). Main Outcomes and Measures: The primary outcome was a composite of all-cause mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. There were 4 secondary outcomes, including days alive and free from antibiotics at day 28, days alive and free from the intensive care unit at day 28, and all-cause mortality at day 90. Seizures, allergic reactions, and mortality were recorded as adverse events. Results: All 607 patients (mean age, 64 [SD, 15] years; 203 were women [33%]) were included in the measurement of the 28-day primary outcome and completed the 90-day mortality follow-up. The majority (369 patients, 61%) had septic shock. The median time from hospital admission to randomization was 9 days (IQR, 3-17 days) and the median duration of meropenem therapy was 11 days (IQR, 6-17 days). Only 1 crossover event was recorded. The primary outcome occurred in 142 patients (47%) in the continuous administration group and in 149 patients (49%) in the intermittent administration group (relative risk, 0.96 [95% CI, 0.81-1.13], P = .60). Of the 4 secondary outcomes, none was statistically significant. No adverse events of seizures or allergic reactions related to the study drug were reported. At 90 days, mortality was 42% both in the continuous administration group (127 of 303 patients) and in the intermittent administration group (127 of 304 patients). Conclusions and Relevance: In critically ill patients with sepsis, compared with intermittent administration, the continuous administration of meropenem did not improve the composite outcome of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. Trial Registration: ClinicalTrials.gov Identifier: NCT03452839.

Noninvasive respiratory support after extubation: a systematic review and network meta-analysis.

BACKGROUND: The effect of noninvasive respiratory support (NRS), including high-flow nasal oxygen, bi-level positive airway pressure and continuous positive airway pressure (noninvasive ventilation (NIV)), for preventing and treating post-extubation respiratory failure is still unclear. Our objective was to assess the effects of NRS on post-extubation respiratory failure, defined as re-intubation secondary to post-extubation respiratory failure (primary outcome). Secondary outcomes included the incidence of ventilator-associated pneumonia (VAP), discomfort, intensive care unit (ICU) and hospital mortality, ICU and hospital length of stay (LOS), and time to re-intubation. Subgroup analyses considered "prophylactic" versus "therapeutic" NRS application and subpopulations (high-risk, low-risk, post-surgical and hypoxaemic patients). METHODS: We undertook a systematic review and network meta-analysis (Research Registry: reviewregistry1435). PubMed, Embase, CENTRAL, Scopus and Web of Science were searched (from inception until 22 June 2022). Randomised controlled trials (RCTs) investigating the use of NRS after extubation in ICU adult patients were included. RESULTS: 32 RCTs entered the quantitative analysis (5063 patients). Compared with conventional oxygen therapy, NRS overall reduced re-intubations and VAP (moderate certainty). NIV decreased hospital mortality (moderate certainty), and hospital and ICU LOS (low and very low certainty, respectively), and increased discomfort (moderate certainty). Prophylactic NRS did not prevent extubation failure in low-risk or hypoxaemic patients. CONCLUSION: Prophylactic NRS may reduce the rate of post-extubation respiratory failure in ICU patients.

Severe and mild-moderate SARS-CoV-2 vaccinated patients show different frequencies of IFNγ-releasing cells: An exploratory study.

BACKGROUND: Despite an apparent effective vaccination, some patients are admitted to the hospital after SARS-CoV-2 infection. The role of adaptive immunity in COVID-19 is growing; nonetheless, differences in the spike-specific immune responses between patients requiring or not hospitalization for SARS-CoV-2 infection remains to be evaluated. In this study, we aim to evaluate the spike-specific immune response in patients with mild-moderate or severeSARS-CoV-2 infection, after breakthrough infection following two doses of BNT162b2 mRNA vaccine. METHODS: We included three cohorts of 15 cases which received the two BNT162b2 vaccine doses in previous 4 to 7 months: 1) patients with severe COVID-19; 2) patients with mild-moderate COVID-19 and 3) vaccinated individuals with a negative SARS-CoV-2 molecular pharyngeal swab (healthy subjects). Anti-S1 and anti-S2 specific SARS-CoV-2 IgM and IgG titers were measured through a chemiluminescence immunoassay technology. In addition, the frequencies of IFNγ-releasing cells were measured by ELISpot. RESULTS: The spike-specific IFNγ-releasing cells were significantly lower in severe patients (8 [0; 26] s.f.c.×106), as compared to mild-moderate patients (135 [64; 159] s.f.c.×106; p<0.001) and healthy subjects (103 [50; 188] s.f.c.×106; p<0.001). The anti-Spike protein IgG levels were similar among the three cohorts of cases (p = 0.098). All cases had an IgM titer below the analytic sensitivity of the test. The Receiver Operating Curve analysis indicated the rate of spike-specific IFNγ-releasing cells can discriminate correctly severe COVID-19 and mild-moderate patients (AUC: 0.9289; 95%CI: 0.8376-1.000; p< 0.0001), with a diagnostic specificity of 100% for s.f.c. > 81.2 x 106. CONCLUSIONS: 2-doses vaccinated patients requiring hospitalization for severe COVID-19 show a cellular-mediated immune response lower than mild-moderate or healthy subjects, despite similar antibody titers.

Benefits of secretion clearance with high frequency percussive ventilation in tracheostomized critically ill patients: a pilot study.

Clearance of secretions remains a challenge in ventilated patients. Despite high-frequency percussive ventilation (HFPV) showing benefits in patients with cystic fibrosis and neuromuscular disorders, very little is known about its effects on other patient categories. Therefore, we designed a physiological pilot study investigating the effects on lung aeration and gas exchange of short HFPV cycles in tracheostomized patients undergoing mechanical ventilation. Electrical impedance tomography (EIT) was recorded at baseline (T0) by a belt wrapped around the patient's chest, followed by the HFPV cycle lasting 10 min. EIT data was collected again after the HFPV cycle (T1) as well as after 1 h (T2) and 3 h (T3) from T0. Variation from baseline of end-expiratory lung impedance (∆EELI), tidal variation (TIV) and global inhomogeneity index (GI) were computed. Arterial blood was also taken for gas analysis. HFPV cycle significantly improved the ∆EELI at T1, T2 and T3 when compared to baseline (p < 0.05 for all comparisons). The ratio between arterial partial pressure and inspired fraction of oxygen (PaO2/FiO2) also increased after the treatment (p < 0.001 for all comparison) whereas TIV (p = 0.132) and GI (p = 0.114) remained unchanged. Short cycles of HFPV superimposed to mechanical ventilation promoted alveolar recruitment, as suggested by improved ∆EELI, and improved oxygenation in tracheostomized patients with high load of secretion.Trial Registration Prospectively registered on www.clinicaltrials.gov (NCT05200507; dated 6th January 2022).

Lung ultrasound to evaluate aeration changes in response to recruitment maneuver and prone positioning in intubated patients with COVID-19 pneumonia: preliminary study.

BACKGROUND: This single-center preliminary prospective observational study used bedside ultrasound to assess the lung aeration modifications induced by recruitment maneuver and pronation in intubated patients with acute respiratory disease syndrome (ARDS) related to coronavirus 2019 disease (COVID-19). All adult intubated COVID-19 patients suitable for pronation were screened. After enrollment, patients underwent 1 h in a volume-controlled mode in supine position (baseline) followed by a 35-cmH2O-recruitment maneuver of 2 min (recruitment). Final step involved volume-controlled mode in prone position set as at baseline (pronation). At the end of the first two steps and 1 h after pronation, a lung ultrasound was performed, and global and regional lung ultrasound score (LUS) were analyzed. Data sets are presented as a median and 25th-75th percentile. RESULTS: From January to May 2022, 20 patients were included and analyzed. Global LUS reduced from 26.5 (23.5-30.0) at baseline to 21.5 (18.0-23.3) and 23.0 (21.0-26.3) at recruitment (p < 0.001) and pronation (p = 0.004). In the anterior lung regions, the regional LUS were 1.8 (1.1-2.0) following recruitment and 2.0 (1.6-2.2) in the supine (p = 0.008) and 2.0 (1.8-2.3) in prone position (p = 0.023). Regional LUS diminished from 2.3 (2.0-2.5) in supine to 2.0 (1.8-2.0) with recruitment in the lateral lung zones (p = 0.036). Finally, in the posterior lung units, regional LUS improved from 2.5 (2.3-2.8) in supine to 2.3 (1.8-2.5) through recruitment (p = 0.003) and 1.8 (1.3-2.2) with pronation (p < 0.0001). CONCLUSIONS: In our investigation, recruitment maneuver and prone positioning demonstrated an enhancement in lung aeration when compared to supine position, as assessed by bedside lung ultrasound. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , Number NCT05209477, prospectively registered and released on 01/26/2022.

Characteristics of unvaccinated and vaccinated critically ill COVID-19 patients in calabria region (Italy): A retrospective study.

Introduction: After the rapid surge of a novel coronavirus (SARS-CoV-2) in 2020 anti-SARS-CoV-2 vaccines have been developed to prevent the development of critical forms of COVID-19 leading to Intensive Care Unit (ICU) admission. The possibility of ICU admission after the first-cycle vaccination has been already reported; however, no data have been published regarding vaccinated patients with a "booster" dose. This retrospective study describes the characteristics of critically ill patients after the implementation of the regional "booster" dose vaccination program in a southern region of Italy. Materials and methods: We screened all medical records of critically ill COVID-19 patients in the period between January to April 2022. We collected the demographic characteristics, the presence of comorbidities, the vaccination status, the clinical course (arterial blood gases and type of respiratory support) and outcomes (rate of tracheostomy, ICU length of stay and mortality). Results: A total of 272 patients were admitted to ICUs during the study period. 161 patients were unvaccinated, whereas 111 were vaccinated with the complete first-cycle or "booster" dose. The type of respiratory support was similar between groups. Vaccinated patients were characterized by a better oxygenation throughout the whole ICU length of stay. Fourteen unvaccinated and 3 vaccinated patients required tracheostomy (p = 0.045). ICU length of stay was 12.2 (± 7.3) days in unvaccinated patients and 10.4 (± 6.7) days in vaccinated patients (p = 0.036). ICU mortalities were 38.5 and 24.3% in unvaccinated and vaccinated patients, respectively (p = 0.014). Conclusion: Vaccinated patients have better clinical course and outcomes as compared to the unvaccinated population.

Post-COVID depression and its multiple factors, does Favipiravir have a protective effect? A longitudinal study of indonesia COVID-19 patients.

BACKGROUND: Coronavirus disease (COVID-19) not only has a long-term effect on its survivors, it also affects their quality of life, including inducing depression as a possible manifestation of central nervous system disruption. Favipiravir shows promising efficacy as an antiviral drug for the treatment of COVID-19. However, its effect on the sequelae of COVID-19 has not been explored. Therefore, this study aims to assess the impact of Favipiravir and address the factors associated with post-COVID depression in Indonesia. METHOD: This cohort study conducted a post-COVID-19 survey on Indonesian patients who were diagnosed by using real-time polymerase chain reaction (RT-PCR) and antigen tests until January 2022. An online questionnaire was distributed to obtain information on demographics, comorbidities, health behavior, symptoms, and treatment. The propensity technique was used to allocate the participants into the favipiravir and nonrecipient groups (1:1). The Patient Health Questionnaire-9 (PHQ-9) was used for outcome measurement. The cohort was followed up biweekly for 60 days after onset/diagnosis to determine the occurrence of depression. Cox regression analysis with an adjusted odds ratio and 95% confidence interval was used to estimate the effect of favipiravir on post-COVID-19 depression. RESULTS: The data included the information of 712 participants, of whom 18.54% had depression within 60 days after onset/diagnosis. Depression was higher in the nonrecipient group (21.06%) than in the favipiravir group (16.01%). After adjustment by other factors, favipiravir prescription was found to be associated with depression (aOR 0.488, 95% CI 0.339-0.701 p < 0.001). In accordance with the PHQ-9 subset, favipiravir exerted a significant protective effect against depressive mood and loss of interest. However, patients living alone were prone to experiencing loss of interest (aOR 2.253, 95% CI 1.329-3.818, p = 0.003). CONCLUSION: The data obtained in this preliminary survey suggested that favipiravir may be useful for preventing post-COVID depression. However, further study is needed. Moreover, the provision of mental health support, particularly to those who live alone, must be ensured. TRIAL REGISTRATION: Registry NCT05060562.

The Role of Autopsy and Post-Mortem Investigations in Falling Traumas in the Hospital Environment.

Falls in a hospital setting are a global public health problem. Despite the production of sensors and various preventive tools to reduce the risk, falls remain a dangerous event with a significant impact on the morbidity and mortality of patients. Despite numerous prevention strategies, falling in the hospital are not always investigated and the autopsy is not always performed in these cases, so it is often not known whether the death is related to the fall or to other causes, inevitably affecting the assessment of any profiles of medical liability for health personnel or for the hospital in the accident. We describe three cases of falls that occurred in different hospitals, in which the autopsy allowed to diagnose with certainty the extent of the trauma and to reconstruct its dynamics. Along with the circumstantial and documentary analyses, deficiencies both in the trauma diagnostics and in the application of the safety measures on the patients were showed. Together with the description of our cases, we propose the post-mortem investigations of these events, both for judicial and risk management purposes.

Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study.

BACKGROUND: Monoclonal antibodies (mAbs) and antivirals have been approved for early therapy of coronavirus disease (COVID-19), however, in the real-life setting, there are difficulties to prescribe these therapies within few days from symptom onset as recommended, and effectiveness of combined use of these drugs have been hypothesised in most-at-risk patients (such as those immunocompromised) but data supporting this strategy are limited. METHODS: We describe the real-life experience of SARS-CoV-2 antivirals and/or monoclonal antibodies (mAbs) and focus on the hospitalisation rate due to the progression of COVID-19. Clinical results obtained through our risk-stratification algorithm and benefits achieved through a strategic proximity territorial centre are provided. We also report a case series with an in-depth evaluation of SARS-CoV-2 genome in relationship with treatment strategy and clinical evolution of patients. RESULTS: Two hundred eighty-eight patients were analysed; 94/288 (32.6%) patients were treated with mAb monotherapy, 171/288 (59.4%) patients were treated with antivirals, and 23/288 (8%) patients received both mAbs and one antiviral drug. Haematological malignancies were more frequent in patients treated with combination therapy than in the other groups (p = 0.0003). There was a substantial increase in the number of treated patients since the opening of the centre dedicated to early therapies for COVID-19. The provided disease-management and treatment appeared to be effective since 98.6% patients recovered without hospital admission. Moreover, combination therapy with mAbs and antivirals seemed successful because all patients admitted to the hospital for COVID-19 did not receive such therapies, while none of the most-at-risk patients treated with combination therapy were hospitalized or reported adverse events. CONCLUSIONS: A low rate of COVID-19 progression requiring hospital admission was observed in patients included in this study. The dedicated COVID-19 proximity territorial service appeared to strengthen the regional sanitary system, avoiding the overwhelming of other services. Importantly, our results also support early combination therapy: it is possible that this strategy reduces the emergence of escape mutants of SARS-CoV-2, thereby increasing efficacy of early treatment, especially in immunocompromised individuals.

Bivalirudin vs. Enoxaparin in Intubated COVID-19 Patients: A Pilot Multicenter Randomized Controlled Trial.

(1) Background: In COVID-19 patients, the occurrence of thromboembolic complications contributes to disease progression and mortality. In patients at increased risk for thrombotic complications, therapeutic enoxaparin should be considered. However, critically ill COVID-19 patients could develop resistance to enoxaparin. Bivalirudin, a thrombin inhibitor, may be an alternative. This pilot multicenter randomized controlled trial aims to ascertain if bivalirudin may reduce the time spent under invasive mechanical ventilation, as compared to enoxaparin. (2) Methods: Intubated COVID-19 patients at risk for thrombo-embolic complications were randomized to receive therapeutic doses of enoxaparin or bivalirudin. We ascertained the time spent under invasive mechanical ventilation during the first 28 days from Intensive Care Unit (ICU) admission. A standardized weaning protocol was implemented in all centers. In addition, we assessed the occurrence of thromboembolic complications, the number of patients requiring percutaneous tracheostomy, the gas exchange, the reintubation rate, the ICU length of stay, the ICU and 28-days mortalities. (3) Results: We enrolled 58 consecutive patients. Bivalirudin did not reduce the time spent under invasive mechanical ventilation as compared to enoxaparin (12 [8; 13] vs. 13 [10; 15] days, respectively; p = 0.078). Thrombotic (p = 0.056) and embolic (p = 0.423) complications, need for tracheostomy (p = 0.423) or reintubation (p = 0.999), the ICU length of stay (p = 0.076) and mortality (p = 0.777) were also similar between treatments. Patients randomized to bivalirudin showed a higher oxygenation at day 7 and 15 after randomization, when compared to enoxaparin group. (4) Conclusions: In intubated COVID-19 patients at increased risk for thromboembolic complications, bivalirudin did not reduce the time spent under invasive mechanical ventilation, nor improved any other clinical outcomes.