Life Experiences in Neuromuscular Tracheotomized Patients in Times of Covid-19.

BACKGROUND: The management of tracheotomy at home can be very complex, affecting the patient's quality of life. OBJECTIVES: This case series study aimed to explore the experiences of patients affected by neuromuscular diseases (NMD) concerning tracheostomy and Invasive Mechanical Ventilation (IMV) management at home during the COVID-19 health emergency in Italy. METHODS: Semi-structured interviews and the following instruments were used: Connor and Davidson Resilience Scale (CD-RISC-25); Acceptance and Action Questionnaire-II (AAQ-II); State-Trait Anxiety Inventory (STAI); Langer Mindfulness Scale (LMS). Descriptive analyses, correlations, and qualitative analyses were carried out. RESULTS: 22 patients [50% female, mean age = 50.2 (SD = 21.2)] participated in the study. Participants who showed high levels of dispositional mindfulness in terms of novelty-seeking (r = 0.736, p = 0.013) and novelty production (r = 0.644, p = 0.033) were those with higher resilience. The main emotion that emerged was the fear of contagion (19 patients, 86.36%), due to the previous fragile condition, leading to a significant sense of abandonment. The tracheostomy's perception is seen in extremes as a lifesaver or a condemnation. The relationship with the health professionals moves from satisfaction to a feeling of abandonment with a lack of preparation. CONCLUSIONS: The relationship between resilience, flexibility, state anxiety and dispositional mindfulness offers ways to reinforce tracheostomy management at home, even in critical periods when going to the hospital may be difficult.

Impact of a Pro-Active Infectious Disease Consultation on the Management of a Multidrug-Resistant Organisms Outbreak in a COVID-19 Hospital: A Three-Months Quasi-Experimental Study.

BACKGROUND: Antimicrobial and diagnostic stewardship (AS/DS) principles are crucial for the management of multidrug-resistant organisms (MDROs) infections. We evaluated the impact of a pro-active Infectious Disease (ID) consultation on the mortality risk of patients during an MDROs outbreak in a COVID-19 hospital. METHODS: A quasi-experimental study was performed in a dedicated COVID-19 hospital, including patients with suspected/confirmed infection and/or colonization by MDROs, which were managed as follows: (i) according to the standard of care during the pre-phase and (ii) in collaboration with a dedicated ID team performing a pro-active bedside evaluation every 48-72 h in the post-phase. RESULTS: Overall, 112 patients were included (pre-phase = 89 and post-phase = 45). The AS interventions included the following: therapy optimization (33%), de-escalation to narrow the spectrum (24%) or to lessen toxic drugs (20%), and discontinuation of antimicrobials (64%). DS included the request of additional microbiologic tests (82%) and instrumental exams (16%). With the Cox model, after adjusting for age, sex, COVID-19 severity, infection source, etiological agents, and post-phase attendance, only age predicted an increased risk of mortality, while attendance in the post-phase resulted in a decreased risk of mortality. CONCLUSIONS: Implementation of AS and DS intervention through a pro-active ID consultation may reduce the risk of 28-day mortality of COVID-19 patients with MDROs infections.

Caregivers of Neuromuscular Patients Living with Tracheostomy during COVID-19 Pandemic: Their Experience.

Background: During a pandemic, tracheostomy management in neuromuscular disease (NMD) patients can be complex. Methods: Using a multicentre, multiple case study approach, we sought perspectives through semi-structured interviews via hybrid quali-quantitative analysis. The qualitative analysis involved a semi-structured interview and the quantitative analysis the completion of a battery of questionnaires. Aim: To investigate the caregivers' experiences, burden and beliefs regarding tracheostomy during the Italian COVID-19 pandemic. The following instruments were administered: Connor and Davidson Resilience Scale (CD-RISC-25); Acceptance and Action Questionnaire-II (AAQ-II); State-Trait Anxiety Inventory (STAI); Langer Mindfulness Scale (LMS); Zarit Burden Interview (ZBI). Results: Fifty-three caregivers (62.3% female, mean age 52.2 (SD = 18.2)) participated in the study. The more resilient the carers, the more they were psychologically flexible (r = 0.380, p = 0.014) and able to cope adaptively with the emergency (r = 0.378, p < 0.006). Similarly, perceived control was higher the more resilient they were (r = 0.897, p < 0.001). The main emotions emerging were isolation and loneliness (15; 34.88%). The perception of tracheostomy meant that it could be seen as a lifesaver or as a condemnation. Similarly, the relationship with health professionals moves from satisfaction to a feeling of abandonment over the course of the pandemic. Conclusions: These findings offer a unique opportunity to understand the point of view of caregivers of NMD patients living with tracheotomy during the COVID-19 pandemic, when going to the hospital may have been hampered.

The impact of healthcare setting on post-COVID mood disorders: a single-centre perspective from Southern Italy Respiratory Intensive Care Unit.

BACKGROUND AND OBJECTIVES: Post-COVID syndrome includes several clinical identities, with both physical and mental alterations lasting several months from the acute phase of COVID-19 disease. However, to date, data concerning the relationship between healthcare settings during COVID-19 disease and post-COVID mood disorders are lacking. METHODS: We performed a prospective study enrolling 440 patients with post-COVID syndrome. Each patient underwent a complete clinical evaluation, along with blood and functional tests. Patients were divided according to the healthcare setting needed during COVID-19 disease. RESULTS: Patients admitted to RICU were more prone to develop mental alterations, even when compared to ICU-admitted patients. Other risk factors for mood disorders included female gender and some post-COVID symptoms. CONCLUSIONS: Healthcare needs during COVID-19 can explain the higher incidence of mood disorders in post-COVID syndrome. RICU arises as an important but underexplored risk factor for post-COVID psychic sequelae.

Is abestos exposure a risk factor for small airways obstruction?

SUMMARY: To the editor, during these pandemic years, COVID-19 is taking away focus from other respiratory diseases such as pneumoconiosis, which should not be overlooked. We would like to emphasize the possible role of small airways in subjects with asbestos exposure. In a very interesting study, Yang et al (1) investigated the relation between increased small airway obstruction and asbestos exposure in patients with asbestosis. The authors evaluated lung function in a cohort of 281 patients with newly diagnosed asbestosis during an eight-year period, evidencing that patients with asbestosis have small airway obstructive defects that are significantly associated with asbestos exposure (1). These results are very consistent and in line with our previous study, in which we showed that a population of 655 long-term residents in an environmental asbestos (tremolite)-exposed area had a higher prevalence of smallairways disease compared to a group of 653 individuals living in areas not tremolite-exposed (2). Odds Ratio for small-airways obstruction was 3.46, irrespective of smoking status (2). To date, our knowledge on the role of small airways in pulmonary diseases is still matter of debate. Although small airways have a minor contribution to airway resistance in healthy subjects, it has been shown that small airways are the major site of airflow limitation in diseases such as asthma and Chronic Obstructive Pulmonary Disease (3). Taken these data together, we warmly encourage clinicians and researchers to always consider small airways parameters when performing lung function on asbestosexposed subjects. Moreover, long-term investigations are warranted to explore the decline in airflow over time in patients with either occupational or environmental asbestos exposure and with asbestosis.

A glimpse in post-COVID pathophysiology: the role of exhaled breath condensate pH as an early marker of residual alveolar inflammation.

BACKGROUND: Residual alveolar inflammation seems to be paramount in post-COVID pathophysiology. Currently, we still lack a reliable marker to detect and track alveolar phlogosis in these patients. Exhaled Breath Condensate (EBC) pH has robust evidences highlighting its correlation with lung phlogosis in various diseases. We aim to define the reliability of alveolar and bronchial EBC pH in the assessment and in the follow up of post-COVID-related inflammation. RESEARCH DESIGN AND METHODS: We enrolled 10 patients previously hospitalized due to COVID-19 pneumonia. We performed a complete follow-up after 3 months and 6 months from discharge. Each visit included routine blood tests, arterial blood gas analysis, 6-minute walking test, spirometry, diffusing capacity and body plethysmography. Finally, bronchial and alveolar EBC were collected at the end of each visit. RESULTS: Alveolar EBC pH was significantly lower than bronchial EBC pH at T1, alveolar EBC pH tended to be more acid after 3 months from hospital discharge compared to the same sample 6 months later. Serum inflammatory biomarkers showed no significant differences from T1 to T2. Alveolar EBC pH was positively correlated with neutrophil-lymphocyte ratio. CONCLUSIONS: Collecting EBC pH could help to understand pathophysiologic mechanism as well as monitoring alveolar inflammation in the post-COVID syndrome.

The impact of healthcare setting on post-COVID mood disorders: A single-centre perspective from Southern Italy Respiratory Intensive Care Unit

Background and objectives Post-COVID syndrome includes several clinical identities, with both physical and mental alterations lasting several months from the acute phase of COVID-19 disease. However, to date, data concerning the relationship between healthcare settings during COVID-19 disease and post-COVID mood disorders are lacking. Methods We performed a prospective study enrolling 440 patients with post-COVID syndrome. Each patient underwent a complete clinical evaluation, along with blood and functional tests. Patients were divided according to the healthcare setting needed during COVID-19 disease. Results Patients admitted to RICU were more prone to develop mental alterations, even when compared to ICU-admitted patients. Other risk factors for mood disorders included female gender and some post-COVID symptoms. Conclusions Healthcare needs during COVID-19 can explain the higher incidence of mood disorders in post-COVID syndrome. RICU arises as an important but underexplored risk factor for post-COVID psychic sequelae.

Switch from Omalizumab to Benralizumab in Allergic Patients with Severe Eosinophilic Asthma: A Real-Life Experience from Southern Italy.

BACKGROUND: The wide availability of monoclonal antibodies for the add-on therapy of severe asthma currently allows for the personalization of biologic treatment by selecting the most appropriate drug for each patient. However, subjects with overlapping allergic and eosinophilic phenotypes can be often eligible to more than one biologic, so that the first pharmacologic choice can be quite challenging for clinicians. Within such a context, the aim of our real-life investigation was to verify whether allergic patients with severe eosinophilic asthma, not adequately controlled by an initial biologic treatment with omalizumab, could experience better therapeutic results from a pharmacologic shift to benralizumab. PATIENTS AND METHODS: Twenty allergic patients with severe eosinophilic asthma, unsuccessfully treated with omalizumab and then switched to benralizumab, were assessed for at least 1 year in order to detect eventual changes in disease exacerbations, symptom control, oral corticosteroid intake, lung function, and blood eosinophils. RESULTS: In comparison to the previous omalizumab therapy, after 1 year of treatment with benralizumab our patients experienced significant improvements in asthma exacerbation rate (p < 0.01), rescue medication need (p < 0.001), asthma control test (ACT) score (p < 0.05), forced expiratory volume in the first second (FEV1) (p < 0.05), and blood eosinophil count (p < 0.0001). Furthermore, with respect to the end of omalizumab treatment, the score of sino-nasal outcome test-22 (SNOT-22) significantly decreased after therapy with benralizumab (p < 0.05). CONCLUSION: The results of this real-life study suggest that the pharmacologic shift from omalizumab to benralizumab can be a valuable therapeutic approach for allergic patients with severe eosinophilic asthma, not adequately controlled by anti-IgE treatment.

Authors' response to the Letter to the Editor regarding: Post severe COVID-19 infection lung damages study. The experience of early three months multidisciplinary follow-up.

To the Editor, we thank Dr Ruggeri et al. for their interest in our previously published manuscript focused on lung damages after severe respiratory COVID-19 infection...

Post severe COVID-19 infection lung damages study. The experience of early three months multidisciplinary follow-up.

The correct type and time of follow-up for patients affected by COVID19 ARDS is still unclear. The aim of this study was to evaluate at the survivors to COVID19 ARDS requiring non-invasive respiratory support (NRS) admitted to a Respiratory Intensive care unit (RICU) from March 8th till May 31th 2020 looking at all sequelae via a comprehensive follow up. All patients underwent a multi-disciplinary instrumental and clinical assessment within three months form admission to evaluate all infection related sequelae. Thirty-eight patients were enrolled Lung-Ultrasound (LUS) showed an outstanding discrimination ability (ROC AUC: 0.95) and a substantial agreement rate (Cohen's K: 0.74) compared to chest CT-scan detecting improvement of lung consolidations. Youden's test showed a cut-off pressure of 11 cmH2O ExpiratoryPAP-Continuous-PAP-max (EPAP-CPAP) applied at the airways during hospitalization to be significantly correlated (p value: 0.026) to the increased pulmonary artery common trunk diameter. A total of 8/38 patients (21.8%), 2 of whom during follow-up, were diagnosed with Pulmonary Emboli (PE) and started anticoagulant treatment. Patients with PE had a statistically significant shorter length of time of hospitalization, time to negative swab, CPAP/NIV duration, P/F ratio and D-dimers at follow-up compared to non PE. A comprehensive approach to patients with ARDS COVID19 requiring NRS is necessary. This study highlighted cardiopulmonary impairment related to the ARDS and to the high-EPAP-CPAP-max greater than 11mmHg provided during admission, the usefulness of LUS in monitoring post-infection recovery and the correct identification and  treatment of patients with PE during follow up.

Predictive Machine Learning Models and Survival Analysis for COVID-19 Prognosis Based on Hematochemical Parameters.

The coronavirus disease 2019 (COVID-19) pandemic has affected hundreds of millions of individuals and caused millions of deaths worldwide. Predicting the clinical course of the disease is of pivotal importance to manage patients. Several studies have found hematochemical alterations in COVID-19 patients, such as inflammatory markers. We retrospectively analyzed the anamnestic data and laboratory parameters of 303 patients diagnosed with COVID-19 who were admitted to the Polyclinic Hospital of Bari during the first phase of the COVID-19 global pandemic. After the pre-processing phase, we performed a survival analysis with Kaplan-Meier curves and Cox Regression, with the aim to discover the most unfavorable predictors. The target outcomes were mortality or admission to the intensive care unit (ICU). Different machine learning models were also compared to realize a robust classifier relying on a low number of strongly significant factors to estimate the risk of death or admission to ICU. From the survival analysis, it emerged that the most significant laboratory parameters for both outcomes was C-reactive protein min; HR=17.963 (95% CI 6.548-49.277, p < 0.001) for death, HR=1.789 (95% CI 1.000-3.200, p = 0.050) for admission to ICU. The second most important parameter was Erythrocytes max; HR=1.765 (95% CI 1.141-2.729, p < 0.05) for death, HR=1.481 (95% CI 0.895-2.452, p = 0.127) for admission to ICU. The best model for predicting the risk of death was the decision tree, which resulted in ROC-AUC of 89.66%, whereas the best model for predicting the admission to ICU was support vector machine, which had ROC-AUC of 95.07%. The hematochemical predictors identified in this study can be utilized as a strong prognostic signature to characterize the severity of the disease in COVID-19 patients.

Impact of smoking, COPD and comorbidities on the mortality of COVID-19 patients.

The prognosis of the coronavirus disease 2019 (COVID-19) patients is variable and depends on several factors. Current data about the impact of chronic obstructive pulmonary disease (COPD) and smoking on the clinical course of COVID-19 are still controversial. This study evaluated the prevalence and the prognosis of COPD patients and smokers in a cohort of 521 patients admitted to four intermediate Respiratory Intensive Care Units (Puglia, Italy) with respiratory failure due to COVID-19 pneumonia. The prevalence of COPD and current smokers was 14% and 13%, respectively. COPD patients had a higher 30-day all-cause mortality than non-COPD patients. Former smokers compared to never smokers and current smokers had higher 30-day all-cause mortality. COPD patients and former smokers had more comorbidities. This study described the prevalence and the outcomes of COPD patients and smokers in a homogenous cohort of COVID-19 patients. The study showed that the prevalence of COPD and current smokers was not high, suggesting that they were not at increased risk of getting the infection. However, when SARS-CoV-2 infection occurred, COPD patients and former smokers were those with the highest all-cause mortality, which seemed to be mainly related to the presence of comorbidities and not to COPD and smoking itself.

Prolonged Active Prone Positioning in Spontaneously Breathing Non-intubated Patients With COVID-19-Associated Hypoxemic Acute Respiratory Failure With PaO2/FiO2 >150.

Background: The COVID-19 pandemic has led to new approaches to manage patients outside the ICU, including prone positioning in non-intubated patients. Objectives: To report the use of prolonged active prone positioning in spontaneously breathing patients with COVID-19-associated acute respiratory failure. Spontaneously breathing vs non-invasive respiratory support for COVID19 associated acute respiratory failure. Methods: Patients with PaO2/FiO2 > 150, with lung posterior consolidations as assessed by means of lung ultrasound, and chest x-ray were studied. Under continuous pulse oximetry (SpO2) monitoring, patients maintained active prone position. A PaO2/FiO2 < 150 was considered as treatment failure and patients had to be switched to non-invasive respiratory support. Retrospectively, data of 16 patients undergoing who refused proning and underwent non-invasive respiratory support were used as controls. The primary outcome was the proportion of patients maintaining prolonged prone position and discharged home. Secondary outcomes included improvement in oxygenation, hospital length of stay, and 6-month survival. Results: Three out of 16 (18.7%) patients did not tolerate the procedure. Three more patients showed a worsening in PaO2/FiO2 to <150 and required non-invasive support, two of whom finally needing endotracheal intubation. After 72 h, 10 out of 16 (62.5%) patients improved oxygenation [PaO2/FiO2: from 194.6 (42.1) to 304.7 (79.3.2) (p < 0.001)] and were discharged home. In the control group, three out of 16 failed, required invasive ventilatory support, and died within 1 month in ICU. Thirteen were successful and discharged home. Conclusion: In non-intubated spontaneously breathing COVID-19 patients with PaO2/FiO2 >150, active prolonged prone positioning was feasible and tolerated with significant improvement in oxygenation.

Galectin-3 as prognostic biomarker in patients with COVID-19 acute respiratory failure.

OBJECTIVES: Galectin-3 is ß-galactoside-binding lectin with several roles in immune-inflammatory response. To date, there is no evidence of Galectin-3 role as a prognostic biomarker in COVID-19 disease. The aim of this study is to clarify the prognostic role of Galectin-3 in patients with COVID 19 acute respiratory failure. METHODS: We enrolled 156 consecutive patients with COVID-19 disease. Routine laboratory test, arterial blood gas, chest X-ray or Computed Tomography and Galectin-3 dosage were performed. The primary outcome was to assess Galectin-3 predictive power for 30-day mortality. Secondary outcomes were 30-day Intensive Care Unit admission and Acute Respiratory Distress Syndrome stratification according to Galectin-3 dosage. We performed Mann-Whitney U and Kruskal-Wallis tests for continuous variables comparison. Fisher's exact test or Chi-square test were used for categorical variables analysis. Receiver Operating Characteristic curves estimated Galectin-3 predictive power for the endpoints. With a fixed cut-off of 35.3 ng/ml, Kaplan-Meier with Log-Rank test and Cox Regression were performed to assess mortality and Intensive Care Unit admission risk. RESULTS: Galectin-3 correlated with many other prognostic predictors tested in our analysis. Moreover, patients with serum levels of Galectin-3 above 35.3 ng/ml had increased risk for mortality, Intensive Care Unit admission and severe Acute Respiratory Distress Syndrome. CONCLUSIONS: Our study demonstrates the role of Galectin-3 as a predictor of mortality, Intensive Care Unit access and ARDS stratification in patients with COVID 19 acute respiratory failure.

COVID-19 clinical phenotypes and short-term outcomes: differences between the first and the second wave of pandemic in Italy.

Objectives: There are no comparative studies between patients belonging to the first and second waves of the SARS-CoV-2 pandemic, the virus triggering coronavirus disease 2019 (COVID-19). In this retrospective observational study, we analyzed the clinical characteristics and the short-term outcomes of two groups of laboratory-confirmed COVID-19 patients with moderate-to-severe acute respiratory distress syndrome (ARDS) belonging to two different waves of the pandemic. Methods: We analyzed 97 consecutive patients from 11 March 2020 to 31 May 2020 and 52 consecutive patients from 28 August 2020 to 15 October 2020. Results: Patients belonging to the second wave were younger, had a lower number of concomitant chronic conditions (multimorbidity), and had a milder clinical phenotype. Medical treatments and respiratory support use have changed during the COVID-19 pandemic, based on different laboratory results and disease clinical features. Patients in the second wave had better short-term clinical outcomes, with lower death rates and more step-down transfers to a general ward. Conclusion: The present findings show a clear phenotypic difference in patients hospitalized at different stages of the COVID-19 pandemic in Italy. These results can help to stratify clinical risk and to better tailor medical treatments and respiratory support for patients with ARDS and COVID-19 pneumonia.

Risk factors for transfer from Respiratory Intermediate Care Unit to Intensive Care Unit in COVID-19.

BACKGROUND: Patients hospitalized for COVID-19-related pneumonia often need several degrees of ventilatory support, which are performed between Respiratory Intermediate Care Units (RICUs) and Intensive Care Units (ICUs), and which depend on the severity of acute respiratory distress syndrome. There is no firm consensus on transfer predictors from the RICU to the ICU. METHODS: In this retrospective observational single center study, we evaluated 96 COVID-19 patients referred to the RICU for acute respiratory failure (ARF) according to their transferal to the ICU or their stay at the RICU. We compared demographic data, baseline laboratory profile, and final clinical outcomes to identify early risk factors for transfer. RESULTS: The best predictors for transfer to the ICU were elevated C-reactive protein and lymphopenia. The mortality rate was lower in the RICU than in the ICU, where transferred patients who died were mostly younger men and with less comorbidities than those in the RICU. CONCLUSIONS: Few inflammatory markers can predict the need for transfer from the RICU to the ICU. Due to the ongoing COVID-19 pandemic, we urge better clinical stratification by early and meaningful profiles in patients admitted to the RICU who are at risk of transferal to the ICU.

Lung ultrasonography for long-term follow-up of COVID-19 survivors compared to chest CT scan.

BACKGROUND: While lung ultrasonography (LUS) has utility for the evaluation of the acute phase of COVID-19 related lung disease, its role in long-term follow-up of this condition has not been well described. The objective of this study is to compare LUS and chest computed tomography (CT) results in COVID-19 survivors with the intent of defining the utility of LUS for long-term follow-up of COVID-19 respiratory disease. METHODS: Prospective observational study that enrolled consecutive survivors of COVID-19 with acute hypoxemic respiratory failure (HARF) admitted to the Respiratory Intensive Care Unit. Three months following hospital discharge, patients underwent LUS, chest CT, body plethysmography and laboratory testing, the comparison of which forms the basis of this report. RESULTS: 38 patients were enrolled, with a total of 190 lobes analysed: men 27/38 (71.1%), mean age 60.6 y (SD 10.4). LUS findings and pulmonary function tests outcomes were compared between patients with and without ILD, showing a statistically significant difference in terms of LUS score (p: 0.0002), FEV1 (p: 0.0039) and FVC (p: 0.012). ROC curve both in lobe by lobe and in patient's overall analysis revealed an outstanding ILD discrimination ability of LUS (AUC: 0.94 and 0.95 respectively) with a substantial Cohen's coefficient (K: 0.74 and 0.69). CONCLUSIONS: LUS has an outstanding discrimination ability compared to CT in identifying an ILD of at least mild grade in the post COVID-19 follow-up. LUS should be considered as the first-line tool in follow-up programs, while chest CT could be performed based on LUS findings.

Surgical mask and N95 in healthcare workers of Covid-19 departments: clinical and social aspects.

Introdution. In order to prevent or slow down the transmission of COVID-19, various public health measures have been introduced, including social distancing, environmental disinfection and the use of personal protective equipment (PPE). In this perspective, the clinical practice of healthcare professionals has changed dramatically. As a matter of fact, the use of surgical masks and N95 has significantly worsened the job performance of workers who deal directly with COVID-19 disease. METHODS: The study included 116 health workers employed in the pulmonology, intensive care and infectious diseases departments of Bari and Foggia Hospital, directly involved in the healthcare of patients affected by COVID-19. Between May 1, 2020 and May 31, 2020, each participant completed an online questionnaire aimed to investigate the impact of the COVID-19 pandemic on workers' lifestyle changes and job performances. We compared the results based on the type of mask used by each participant (surgical mask vs N95). RESULTS: Although disturbances related to the use of the mask arose earlier in subjects who wore the N95 (p = 0.0094), healthcare workers that wore surgical masks reported a statistically higher average score for a greater number of disorders. CONCLUSIONS: This is the first study that compares the effects of the two most used PPE on the quality of life of health workers and which highlights the greater discomfort caused by surgical masks. This result brings to light a serious social problem, being surgical masks widely used in everyday life by ordinary people and non-healthcare workers.