IntroductionThe Coronavirus 2(SARS-CoV-2) outbreak spread rapidly in Italy and the lack of intensive care unit(ICU) beds soon became evident, forcing the application of noninvasive respiratory support(NRS) outside the ICU, raising concerns over staff contamination. We aimed to analyse the safety of the hospital staff, the feasibility, and outcomes of NRS applied to patients outside the ICU.MethodsIn this observational study, data from 670 consecutive patients with confirmed COVID-19 referred to the Pulmonology Units in nine hospitals between March 1st and May 10th,2020 were analysed. Data were collected including medication, mode and usage of the NRS (i.e. high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), noninvasive ventilation(NIV)), length of stay in hospital, endotracheal intubation(ETI) and deaths.ResultsForty-two health-care workers (11.4%) tested positive for infection, but only three of them required hospitalisation. Data are reported for all patients (69.3% male), whose mean age was 68 (sd 13) years. The PaO2/FiO2 ratio at baseline was 152±79, and the majority of patients (49.3%) were treated with CPAP. The overall unadjusted 30-day mortality rate was 26.9% with 16%, 30%, and 30%, while the total ETI rate was 27% with 29%, 25% and 28%, for HFNC, CPAP, and NIV, respectively, and the relative probability to die was not related to the NRS used after adjustment for confounders. ETI and length of stay were not different among the groups. Mortality rate increased with age and comorbidity class progression.ConclusionsThe application of NRS outside the ICU is feasible and associated with favourable outcomes. Nonetheless, it was associated with a risk of staff contamination.
RationalePulse glucocorticoid therapy is used in hyperinflammation related to coronavirus 2019 (COVID-19). We evaluated the efficacy and safety of pulse intravenous methylprednisolone in addition to standard treatment in COVID-19 pneumonia.MethodsIn this multicenter, randomised, double-blind, placebo-controlled trial, 304 hospitalised patients with Covid-19 pneumonia were randomised to receive 1 g of methylprednisolone intravenously for 3 consecutive days or placebo in addition to standard dexamethasone. The primary outcome was the duration of the patient hospitalisation, calculated as the time interval between randomisation and hospital discharge without the need of supplementary oxygen. The key secondary outcomes were survival free from invasive ventilation with orotracheal intubation and overall survival.ResultsOverall, 112 of 151 (75.4%) patients in the pulse methylprednisolone arm and 111 of 150 (75.2%) in the placebo arm were discharged from hospital without oxygen within 30 days from randomisation. Median time to discharge was similar in both groups [15 days (95% confidence interval (CI), 13.0 to 17.0) and 16 days (95%CI, 13.8 to 18.2); hazard ratio (HR), 0.92; 95% CI 0.71–1.20; p=0.528]. No significant differences between pulse methylprednisolone and placebo arms were observed in terms of admission to Intensive Care Unit with orotracheal intubation or death (20.0% versus 16.1%; HR, 1.26; 95%CI, 0.74–2.16; p=0.176), or overall mortality (10.0% versus 12.2%; HR, 0.83; 95%CI, 0.42–1.64; p=0.584). Serious adverse events occurred with similar frequency in the two groups.ConclusionsMethylprenisolone pulse therapy added to dexamethasone was not of benefit in patients with COVID-19 pneumonia.Message of the studyPulse glucocorticoid therapy is used for severe and/or life threatening immuno-inflammatory diseases. The addition of pulse glucocorticoid therapy to the standard low dose of dexamethasone scheme was not of benefit in patients with COVID-19 pneumonia.
At a Glance CommentaryScientific Knowledge on the Subject: In order to identify patients in the initial stages of ARDS, and facilitate inclusion into clinical trials aimed at earlier treatment, several studies have suggested diagnosing ARDS in the patients not receiving mechanical ventilation.However, the oxygenation criterion of the Berlin definition states that for the diagnosis of moderate or severe ARDS, a patient must be on invasive mechanical ventilation with a PEEP > 5 cmH 2 O, when the PaO2/FiO2 is measured; while for the diagnosis of mild ARDS the patient can be receiving PEEP or CPAP > 5 cmH 2 O also delivered non-invasively. Several
Up to fifteen percent of patients with novel pandemic coronavirus disease have acute respiratory failure (ARF). Ratio between arterial partial pressure of oxygen (PaO2) and fraction of inspired oxygen (FiO2), P/F, is currently used as a marker of ARF severity in Covid-19. P/F does not reflect the respiratory efforts made by patients to maintain arterial blood oxygenation, such as tachypnea and hyperpnea, leading to hypocapnia. Standard PaO2, the value of PaO2 adjusted for arterial partial pressure of carbon dioxide (PaCO2) of the subject, better reflects the pathophysiology of hypoxemic ARF. We hypothesized that the ratio between standard PaO2 over FiO2 (STP/F) better predicts Covid-19 ARF severity compared to P/F. Methods: Aim of this pilot prospectic observational study was to observe differences between STP/F and P/F in predicting outcome failure, defined as need of invasive mechanical ventilation and/or deaths in Covid-19 ARF. Accuracy was calculated using Receiver Operating Characteristics (ROC) analysis and areas under the ROC curve (AUROC) were compared. Results: 349 consecutive subjects admitted to our respiratory wards due to Covid-19 ARF were enrolled. STP/F was accurate to predict mortality and superior to P/F with, respectively, AUROC 0.710 versus 0.688, p = 0.012. Both STP/F and PF were accurate to predict outcome failure (AUROC respectively of 0.747 and 0.742, p = 0.590).
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