Summary Purpose To determine whether a 6-day course of methylprednisolone (MP) improves outcome in patients with severe SARS-CoV‑2 (Corona Virus Disease 2019 [COVID-19]). Methods The study was a multicentric open-label trial of COVID-19 patients who were aged ≥ 18 years, receiving oxygen without mechanical ventilation, and with evidence of systemic inflammatory response who were assigned to standard of care (SOC) or SOC plus intravenous MP (40 mg bid for 3 days followed by 20 mg bid for 3 days). The primary outcome was a composite of death, admission to the intensive care unit, or requirement for noninvasive ventilation. Both intention-to-treat (ITT) and per protocol (PP) analyses were performed. Results A total of 91 patients were screened, and 64 were randomized (mean age70 ± 12 years). In the ITT analysis, 14 of 29 patients (48%) in the SOC group and 14 of 35 (40%) in the MP group suffered the composite endpoint (40% versus 20% in patients under 72 years and 67% versus 48% in those over 72 years; p = 0.25). In the PP analysis, patients on MP had a significantly lower risk of experiencing the composite endpoint (age-adjusted risk ratio 0.42; 95% confidence interval, CI 0.20–0.89; p = 0.043). Conclusion The planned sample size was not achieved, and our results should therefore be interpreted with caution. The use of MP had no significant effect on the primary endpoint in ITT analysis; however, the PP analysis showed a beneficial effect due to MP, which consistent with other published trials support the use of glucocorticoids in severe cases of COVID-19. Supplementary Information The online version of this article (10.1007/s00508-020-01805-8) contains supplementary material, which is available to authorized users.
Background. We aimed to determine whether a 6-day course of intravenous methylprednisolone (MP) improves outcome in patients with SARS CoV-2 infection at risk of developing Acute Respiratory Distress Syndrome (ARDS). Methods. Multicentric, partially randomized, preference, open-label trial, including adults with COVID-19 pneumonia, impaired gas exchange and biochemical evidence of hyper-inflammation. Patients were assigned to standard of care (SOC), or SOC plus intravenous MP [40mg/12h 3 days, then 20mg/12h 3 days]. The primary endpoint was a composite of death, admission to the intensive care unit (ICU) or requirement of non-invasive ventilation (NIV). Results. We analyzed 85 patients (34, randomized to MP; 22, assigned to MP by clinician preference; 29, control group). Patient age (mean 68±yr) was related to outcome. The use of MP was associated with a reduced risk of the composite endpoint in the intention-to-treat, age-stratified analysis (combined risk ratio -RR- 0.55 [95% CI 0.33-0.91]; p=0.024). In the per-protocol analysis, RR was 0.11 (0.01-0.83) in patients aged 72 yr or less, 0.61 (0.32-1.17) in those over 72 yr, and 0.37 (0.19-0.74, p=0.0037) in the whole group after age-adjustment by stratification. The decrease in C-reactive protein levels was more pronounced in the MP group (p=0.0003). Hyperglycemia was more frequent in the MP group. Conclusions A short course of MP had a beneficial effect on the clinical outcome of severe COVID-19 pneumonia, decreasing the risk of the composite end point of admission to ICU, NIV or death.
Automated analysis of overnight oximetry may be used to develop reliable as well as accurate screening tools for childhood OSAS.
Symbolic dynamics provides complementary information to conventional oximetry analysis enabling reliable detection of moderate-to-severe paediatric OSAHS from portable oximetry.
Introduction. Overnight oximetry has been proposed as an accessible, simple, and reliable technique for obstructive sleep apnea syndrome (OSAS) diagnosis. From visual inspection to advanced signal processing, several studies have demonstrated the usefulness of oximetry as a screening tool. However, there is still controversy regarding the general application of oximetry as a single screening methodology for OSAS.Areas covered. Currently, high-resolution portable devices combined with pattern recognitionbased applications are able to achieve high performance in the detection this disease. In this review, recent studies involving automated analysis of oximetry by means of advanced signal processing and machine learning algorithms are analyzed. Advantages and limitations are highlighted and novel research lines aimed at improving the screening ability of oximetry are proposed. Expert commentary. Oximetry is a cost-effective tool for OSAS screening in patients showinghigh pretest probability for the disease. Nevertheless, exhaustive analyses are still needed to further assess unattended oximetry monitoring as a single diagnostic test for sleep apnea, particularly in the pediatric population and in especial groups with significant comorbidities. In the following years, communication technologies and big data analysis will overcome current limitations of simplified sleep testing approaches, changing the detection and management of OSAS.
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