Long-term outcome of COVID-19 patients treated with helmet noninvasive ventilation vs. high-flow nasal oxygen: a randomized trial.

BACKGROUND: Long-term outcomes of patients treated with helmet noninvasive ventilation (NIV) are unknown: safety concerns regarding the risk of patient self-inflicted lung injury and delayed intubation exist when NIV is applied in hypoxemic patients. We assessed the 6-month outcome of patients who received helmet NIV or high-flow nasal oxygen for COVID-19 hypoxemic respiratory failure. METHODS: In this prespecified analysis of a randomized trial of helmet NIV versus high-flow nasal oxygen (HENIVOT), clinical status, physical performance (6-min-walking-test and 30-s chair stand test), respiratory function and quality of life (EuroQoL five dimensions five levels questionnaire, EuroQoL VAS, SF36 and Post-Traumatic Stress Disorder Checklist for the DSM) were evaluated 6 months after the enrollment. RESULTS: Among 80 patients who were alive, 71 (89%) completed the follow-up: 35 had received helmet NIV, 36 high-flow oxygen. There was no inter-group difference in any item concerning vital signs (N = 4), physical performance (N = 18), respiratory function (N = 27), quality of life (N = 21) and laboratory tests (N = 15). Arthralgia was significantly lower in the helmet group (16% vs. 55%, p = 0.002). Fifty-two percent of patients in helmet group vs. 63% of patients in high-flow group had diffusing capacity of the lungs for carbon monoxide < 80% of predicted (p = 0.44); 13% vs. 22% had forced vital capacity < 80% of predicted (p = 0.51). Both groups reported similar degree of pain (p = 0.81) and anxiety (p = 0.81) at the EQ-5D-5L test; the EQ-VAS score was similar in the two groups (p = 0.27). Compared to patients who successfully avoided invasive mechanical ventilation (54/71, 76%), intubated patients (17/71, 24%) had significantly worse pulmonary function (median diffusing capacity of the lungs for carbon monoxide 66% [Interquartile range: 47-77] of predicted vs. 80% [71-88], p = 0.005) and decreased quality of life (EQ-VAS: 70 [53-70] vs. 80 [70-83], p = 0.01). CONCLUSIONS: In patients with COVID-19 hypoxemic respiratory failure, treatment with helmet NIV or high-flow oxygen yielded similar quality of life and functional outcome at 6 months. The need for invasive mechanical ventilation was associated with worse outcomes. These data indicate that helmet NIV, as applied in the HENIVOT trial, can be safely used in hypoxemic patients. Trial registration Registered on clinicaltrials.gov NCT04502576 on August 6, 2020.

COVID-19 pandemic in the intensive care unit: Psychological implications and interventions, a systematic review.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic produced changes in intensive care units (ICUs) in patient care and health organizations. The pandemic event increased patients' risk of developing psychological symptoms during and after hospitalisation. These consequences also affected those family members who could not access the hospital. In addition, the initial lack of knowledge about the virus and its management, the climate of fear and uncertainty, the increased workload and the risk of becoming infected and being contagious, had a strong impact on healthcare staff and organizations. This highlighted the importance of interventions aimed at providing psychological support to ICUs, involving patients, their relatives, and the staff; this might involve the reorganisation of the daily routine and rearrangement of ICU staff duties. AIM: To conduct a systematic review of psychological issues in ICUs during the COVID-19 pandemic involving patients, their relatives, and ICU staff. METHODS: We investigated the PubMed and the ClinicalTrials.gov databases and found 65 eligible articles, upon which we commented. RESULTS: Our results point to increased perceived stress and psychological distress in staff, patients and their relatives and increased worry for being infected with severe acute respiratory syndrome coronavirus-2 in patients and relatives. Furthermore, promising results were obtained for some psychological programmes aiming at improving psychological measures in all ICU categories. CONCLUSION: As the pandemic limited direct inter-individual interactions, the role of interventions using digital tools and virtual reality is becoming increasingly important. All considered, our results indicate an essential role for psychologists in ICUs.

Comparative bench study evaluation of a modified snorkeling mask used during COVID-19 pandemic and standard interfaces for non-invasive ventilation.

PURPOSE: The aim of this bench study is to compare the standard NIV and nCPAP devices (Helmet, H; Full face mask, FFM) with a modified full face snorkeling mask used during COVID-19 pandemic. METHODS: A mannequin was connected to an active lung simulator. The inspiratory and expiratory variations in airways pressure observed with a high simulated effort, were determined relative to the preset CPAP level. NIV was applied in Pressure Support Mode at two simulated respiratory rates and two cycling-off flow thresholds. During the bench study, we measured the variables defining patient-ventilator interaction and performance. RESULTS: During nCPAP, the tested interfaces did not show significant differences in terms of ∆Pawi and ∆Pawe. During NIV, the snorkeling mask demonstrated a better patient-ventilator interaction compared to FFM, as shown by significantly shorter Pressurization Time and Expiratory Trigger Delay (p < 0.01), but no significant differences were found in terms of Inspiratory Trigger Delay and Time of Synchrony between the interfaces tested. At RR 20sim, the snorkeling mask presented the lower ΔPtrigger (p < 0.01), moreover during all the conditions tested the snorkeling mask showed the longer Pressure Time Product at 200, 300, and 500 ms compared to FFM (p < 0.01). A major limitation of snorkeling mask is that during NIV with this interface it is possible to reach maximum 18 cmH2O of peak inspiratory pressure. CONCLUSIONS: The modified snorkeling mask can be used as an acceptable alternative to other interfaces for both nCPAP and NIV in emergencies.

Should high-flow through nasal cannula be used during bronchoscopy in critically ill patients with hypoxemic acute respiratory failure?

Flexible fiberoptic bronchoscopy (FOB) is an invasive procedure with diagnostic and/or therapeutic purposes commonly used in critically ill patients. FOB may be complicated by desaturation, onset or worsening of the respiratory failure, and hemodynamic instability due to cardio-respiratory alterations occurring during the procedure. Increasing evidences suggest the use of high-flow through nasal cannula (HFNC) over conventional oxygen therapy (COT) in critically ill patients with acute respiratory failure (ARF). Indeed, HFNC has a rationale and possible physiologic advantages, even during FOB. However, to date, evidences in favor of HFNC over COT or continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) during FOB are still weak. Nonetheless, in critically ill patients with hypoxemic ARF, the choice of the oxygenation strategy during a FOB is challenging. Based on a review of the literature, HFNC may be preferred over COT in patients with mild to moderate hypoxemic ARF, without cardiac failure or hemodynamic instability. On the opposite, in critically ill patients with more severe hypoxemic ARF or in the presence of cardiac failure or hemodynamic instability, CPAP or NIV, applied with specifically designed interfaces, may be preferred over HFNC.

Impact of the "atherosclerotic pabulum" on in-hospital mortality for SARS-CoV-2 infection. Is calcium score able to identify at-risk patients?

BACKGROUND: Although the primary cause of death in COVID-19 infection is respiratory failure, there is evidence that cardiac manifestations may contribute to overall mortality and can even be the primary cause of death. More importantly, it is recognized that COVID-19 is associated with a high incidence of thrombotic complications. HYPOTHESIS: Evaluate if the coronary artery calcium (CAC) score was useful to predict in-hospital (in-H) mortality in patients with COVID-19. Secondary end-points were needed for mechanical ventilation and intensive care unit admission. METHODS: Two-hundred eighty-four patients (63, 25 years, 67% male) with proven severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection who had a noncontrast chest computed tomography were analyzed for CAC score. Clinical and radiological data were retrieved. RESULTS: Patients with CAC had a higher inflammatory burden at admission (d-dimer, p = .002; C-reactive protein, p = .002; procalcitonin, p = .016) and a higher high-sensitive cardiac troponin I (HScTnI, p = <.001) at admission and at peak. While there was no association with presence of lung consolidation and ground-glass opacities, patients with CAC had higher incidence of bilateral infiltration (p = .043) and higher in-H mortality (p = .048). On the other side, peak HScTnI >200 ng/dl was a better determinant of all outcomes in both univariate (p = <.001) and multivariate analysis (p = <.001). CONCLUSION: The main finding of our research is that CAC was positively related to in-H mortality, but it did not completely identify all the population at risk of events in the setting of COVID-19 patients. This raises the possibility that other factors, including the presence of soft, unstable plaques, may have a role in adverse outcomes in SARS-CoV-2 infection.

The effects of COVID-19 outbreak on pediatric emergency department admissions for acute wheezing.

INTRODUCTION: Acute wheezing is a common clinical presentation of viral respiratory infections in children, which can also be caused by exposure to allergens and, rarely, by foreign body inhalation. Since the beginning of the COVID-19 (coronavirus disease 2019) outbreak, several public health interventions have been adopted to reduce viral spread. The aim of this study was to analyze the impact of the COVID-19 pandemic and lockdown measures on Pediatric Emergency Department (ED) admission for acute wheezing. MATERIALS AND METHODS: We compared demographics and clinical data of patients admitted to the ED for acute wheezing during the COVID-19 outbreak and in the 5 previous years through a retrospective cross-sectional study. RESULTS: During the COVID-19 outbreak we observed an average drop of 83% in pediatric ED admission for acute wheezing, compared to the 5 previous years. In this period, 121 (80.7%) children presented with wheezing and 29 (19.3%) with bronchiolitis. The mean age of the sample was higher compared to the 5 previous years. We also noted an increased number of children presenting with higher acuity color codes during the COVID-19 period, while no differences emerged as for the hospitalizations. During the pandemic we recorded a decrease in the number of viral infections detected. Only two cases of wheezing associated with SARS-CoV-2 were identified. CONCLUSION: The COVID-19 outbreak and the national lockdown led to a drop of the number of admission to the ED for wheezing in children. This could be due to a reduction in the circulation of common respiratory viruses and partially to a reduced exposure to aeroallergens during the COVID-19 period. Future epidemiological surveillance studies will be needed to support these prelimianry findings.

Impact of ‘atherosclerotic pabulum’ on in hospital mortality for SARS-CoV-2 infection. Is calcium score alone enough to identify at risk patients?

Although the primary cause of death in COVID-19 infection is respiratory failure, there are evidences that cardiac manifestations may contribute to overall mortality and can even be the primary cause of death. More importantly, it is recognized that COVID-19 is associated with a high incidence of thrombotic complications. Two-hundred-eighty-four patients with proven SARS-CoV-2 infection who had a non-contrast Chest CT at our facility were analysed for coronary calcium score. Clinical and radiological data were retrieved. Patients with coronary calcium had higher inflammatory burden at admission (d-dimer, CRP, Procalcitonin) and higher Troponin at admission and at zenith. While there was no correlation with presence of consolidation and ground glass opacities, patients with coronary calcium had higher incidence of bilateral infiltration and higher in-hospital mortality. Peak troponin was associated with higher mortality, intensive care unit admission and mechanical ventilation in both univariable at multivariate analysis. Calcium score has demonstrated to be a good prognostic indicator for in-hospital mortality in patients with SARS-CoV-2 infection. Patients with higher atherosclerotic burden are at higher risk of fatality and complications. Our findings could have significant clinical implications in selecting at risk patients for allocation of resources especially in those with ‘atherosclerotic pabulum’, where inflammation activated by SARS-CoV-2 may play a role in fatal and non-fatal events.

Research on SARS-COV-2 pandemic: a narrative review focused on the Italian contribution.

BACKGROUND: Since late 2019, a severe acute respiratory syndrome, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has spread with overwhelming speed causing over 214 million confirmed infections and more than 4.5 million deaths worldwide. In this framework, Italy had the second highest number of SARS-CoV-2 infections worldwide, and the largest number of deaths. A global effort of both the scientific community and governments has been undertaken to stem the pandemic. The aim of this paper is to perform a narrative review of the Italian contribution to the scientific literature regarding intensive care management of patients suffering from COVID-19, being one of the first western countries to face an outbreak of SARS-CoV-2 infection. MAIN BODY: We performed a narrative review of the literature, dedicating particular attention and a dedicated paragraph to ventilatory support management, chest imaging findings, biomarkers, possible pharmacological interventions, bacterial superinfections, prognosis and non-clinical key aspects such as communication and interaction with relatives. CONCLUSIONS: Many colleagues, nurses and patients died leaving their families alone. To all of them, we send our thoughts and dedicate these pages.

Botulism during SARS-CoV-2 pandemic: The importance of differential diagnoses.

Botulism is a neuroparalytic syndrome caused by a neurotoxin produced by Clostridium botulinum. We describe a patient with neurological symptoms associated with intoxication by Clostridium botulinum and infection by SARSCoV2. This report underlines that it is mandatory, even in case of SARS-CoV-2 positivity, to investigate all the causes of a clinical pattern.

Effect of Helmet Noninvasive Ventilation vs High-Flow Nasal Oxygen on Days Free of Respiratory Support in Patients With COVID-19 and Moderate to Severe Hypoxemic Respiratory Failure: The HENIVOT Randomized Clinical Trial.

Importance: High-flow nasal oxygen is recommended as initial treatment for acute hypoxemic respiratory failure and is widely applied in patients with COVID-19. Objective: To assess whether helmet noninvasive ventilation can increase the days free of respiratory support in patients with COVID-19 compared with high-flow nasal oxygen alone. Design, Setting, and Participants: Multicenter randomized clinical trial in 4 intensive care units (ICUs) in Italy between October and December 2020, end of follow-up February 11, 2021, including 109 patients with COVID-19 and moderate to severe hypoxemic respiratory failure (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen ≤200). Interventions: Participants were randomly assigned to receive continuous treatment with helmet noninvasive ventilation (positive end-expiratory pressure, 10-12 cm H2O; pressure support, 10-12 cm H2O) for at least 48 hours eventually followed by high-flow nasal oxygen (n = 54) or high-flow oxygen alone (60 L/min) (n = 55). Main Outcomes and Measures: The primary outcome was the number of days free of respiratory support within 28 days after enrollment. Secondary outcomes included the proportion of patients who required endotracheal intubation within 28 days from study enrollment, the number of days free of invasive mechanical ventilation at day 28, the number of days free of invasive mechanical ventilation at day 60, in-ICU mortality, in-hospital mortality, 28-day mortality, 60-day mortality, ICU length of stay, and hospital length of stay. Results: Among 110 patients who were randomized, 109 (99%) completed the trial (median age, 65 years [interquartile range {IQR}, 55-70]; 21 women [19%]). The median days free of respiratory support within 28 days after randomization were 20 (IQR, 0-25) in the helmet group and 18 (IQR, 0-22) in the high-flow nasal oxygen group, a difference that was not statistically significant (mean difference, 2 days [95% CI, -2 to 6]; P = .26). Of 9 prespecified secondary outcomes reported, 7 showed no significant difference. The rate of endotracheal intubation was significantly lower in the helmet group than in the high-flow nasal oxygen group (30% vs 51%; difference, -21% [95% CI, -38% to -3%]; P = .03). The median number of days free of invasive mechanical ventilation within 28 days was significantly higher in the helmet group than in the high-flow nasal oxygen group (28 [IQR, 13-28] vs 25 [IQR 4-28]; mean difference, 3 days [95% CI, 0-7]; P = .04). The rate of in-hospital mortality was 24% in the helmet group and 25% in the high-flow nasal oxygen group (absolute difference, -1% [95% CI, -17% to 15%]; P > .99). Conclusions and Relevance: Among patients with COVID-19 and moderate to severe hypoxemia, treatment with helmet noninvasive ventilation, compared with high-flow nasal oxygen, resulted in no significant difference in the number of days free of respiratory support within 28 days. Further research is warranted to determine effects on other outcomes, including the need for endotracheal intubation. Trial Registration: ClinicalTrials.gov Identifier: NCT04502576.

Retrospective Analysis of a Modified Organizational Model to Guarantee CT Workflow during the COVID-19 Outbreak in the Tertiary Hospital of Padova, Italy.

At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) outbreak in Italy, the cluster of Vò Euganeo was managed by the University Hospital of Padova. The Department of Diagnostic Imaging (DDI) conceived an organizational approach based on three different pathways for low-risk, high-risk, and confirmed Coronavirus Disease 19 (COVID-19) patients to accomplish three main targets: guarantee a safe pathway for non-COVID-19 patients, ensure health personnel safety, and maintain an efficient workload. Thus, an additional pathway was created with the aid of a trailer-mounted Computed Tomography (CT) scanner devoted to positive patients. We evaluated the performance of our approach from February 21 through April 12 in terms of workload (e.g., number of CT examinations) and safety (COVID-19-positive healthcare workers). There was an average of 72.2 and 17.8 COVID-19 patients per day in wards and the Intensive Care Unit (ICU), respectively. A total of 176 high-risk and positive patients were examined. High Resolution Computed Tomography (HRCT) was one of the most common exams, and 24 pulmonary embolism scans were performed. No in-hospital transmission occurred in the DDI neither among patients nor among health personnel. The weekly number of in-patient CT examinations decreased by 27.4%, and the surgical procedures decreased by 29.5%. Patient screening and dedicated diagnostic pathways allowed the maintenance of high standards of care while working in safety.

Children's Healthcare During Corona Virus Disease 19 Pandemic: the Italian Experience.

The unexpected outbreak of Corona Virus Disease 19 had several consequences worldwide and on the Italian Health System. We report our experience in the reorganization of our Pediatric Department to prevent the risk of infection for both children and staff. We strongly believe that the need to face an unpredictable emergency situation should not affect the quality of the assistance to the non-Corona Virus Disease patients.

Validation of a composed COVID-19 chest radiography score: the CARE project.

OBJECTIVES: The aim of this study was to validate a composed coronavirus disease 2019 (COVID-19) chest radiography score (CARE) based on the extension of ground-glass opacity (GG) and consolidations (Co), separately assessed, and to investigate its prognostic performance. METHODS: COVID-19-positive patients referring to our tertiary centre during the first month of the outbreak in our area and with a known outcome were retrospectively evaluated. Each lung was subdivided into three areas and a three-grade score assessing the extension of GG and Co was used. The CARE was derived from the sum of the subscores. A mixed-model ANOVA with post hoc Bonferroni correction was used to evaluate whether differences related to the referring unit (emergency room, COVID-19 wards and intensive care unit (ICU)) occurred. Logistic regression analyses were used to investigate the impact of CARE, patients' age and sex on the outcome. To evaluate the prognostic performance of CARE, receiver operating characteristic curves were computed for the entire stay and at admission only. RESULTS: A total of 1203 chest radiographs of 175 patients (120 males; mean age 67.81±15.5 years old) were examined. On average, each patient underwent 6.8±10.3 radiographs. Patients in ICU as well as deceased patients showed higher CARE scores (p<0.05, each). Age, Co and CARE significantly influenced the outcome (p<0.05 each). The CARE demonstrated good accuracy (area under the curve (AUC)=0.736) using longitudinal data as well as at admission only (AUC=0.740). A CARE score of 17.5 during hospitalisation showed 75% sensitivity and 69.9% specificity. CONCLUSIONS: The CARE was demonstrated to be a reliable tool to assess the severity of pulmonary involvement at chest radiography with a good prognostic performance.

Retrospective Analysis of a Modified Organizational Model to Guarantee CT Workflow during the COVID-19 Outbreak in the Tertiary Hospital of Padova, Italy

At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) outbreak in Italy, the cluster of VòEuganeo was managed by the University Hospital of Padova. The Department of Diagnostic Imaging (DDI) conceived an organizational approach based on three different pathways for low-risk, high-risk, and confirmed Coronavirus Disease 19 (COVID-19) patients to accomplish three main targets: guarantee a safe pathway for non-COVID-19 patients, ensure health personnel safety, and maintain an efficient workload. Thus, an additional pathway was created with the aid of a trailer-mounted Computed Tomography (CT) scanner devoted to positive patients. We evaluated the performance of our approach from February 21 through April 12 in terms of workload (e.g., number of CT examinations) and safety (COVID-19-positive healthcare workers). There was an average of 72.2 and 17.8 COVID-19 patients per day in wards and the Intensive Care Unit (ICU), respectively. A total of 176 high-risk and positive patients were examined. High Resolution Computed Tomography (HRCT) was one of the most common exams, and 24 pulmonary embolism scans were performed. No in-hospital transmission occurred in the DDI neither among patients nor among health personnel. The weekly number of in-patient CT examinations decreased by 27.4%, and the surgical procedures decreased by 29.5%. Patient screening and dedicated diagnostic pathways allowed the maintenance of high standards of care while working in safety.

Radiological management of COVID-19: structure your diagnostic path to guarantee a safe path.

The current COVID-19 outbreak is requiring a tremendous effort not only regarding the diagnostic and therapeutic approach but also in terms of global management of the delivered care. Hospital administrations had to provide a prompt response to a rapidly evolving emergency characterized by the necessity of giving access to an enormous number of infected patients, guaranteeing appropriate care to patients in need of other types of treatment, and simultaneously preserving the well-being of healthcare providers. To optimize the diagnostic pathway during the current COVID-19 outbreak, the hospital administration of our tertiary center applied a highly structured framework assigning specific tasks to the different units composing the Department of Imaging. In particular, since the beginning of the pandemic, a mobile CT scanner in a truck was rented and became operative for all patients with a confirmed diagnosis of COVID-19 and another CT was assigned for all suspected cases. The success and efficacy of the management applied by our administration is demonstrated by the fact that during the outbreak, the radiological workflow was never interrupted. In fact, despite the national lockdown only a 29.3% decrease of CT scans occurred compared to the previous year. Moreover, none of the healthcare providers of the Department contracted the infection at work. Thus, according to the experience gained in our center, we recommend to all hospital administrations facing the COVID-19 outbreak to promptly adapt their resources, creating precise and safe pathways for their diagnostic units.

It's not over until it's over: the chameleonic behavior of COVID-19 over a six-day period.

The current global outbreak of COVID-19 represents a major challenge in terms of epidemiology, contagiousness, treatment, as well as clinical and radiological behavior of this disease. Radiological imaging plays a key role in the diagnostic process and during the monitoring of the clinical conditions especially of patients with severe symptoms. According to the preliminary data collected in our tertiary center, we have documented a peculiar behavior in patients requiring endotracheal intubation who underwent seriate chest X-rays. In fact, the radiological pattern of COVID-19 patients may worsen despite a prompt amelioration after the onset of mechanical ventilation. Thus, according to our initial evidence, we recommend to perform seriate chest X-rays in the days following the onset of mechanical ventilation even if the immediate monitoring suggests an improvement. Studies on a larger scale are necessary to fully assess the findings at chest radiographs of critical, mechanically ventilated patients and their correlation with the long-term outcome.