Background The COVID-19 pandemic has led highly developed healthcare systems to the brink of collapse due to the large numbers of patients being admitted into hospitals. One of the potential prognostic indicators in patients with COVID-19 is frailty. The degree of frailty could be used to assist both the triage into intensive care, and decisions regarding treatment limitations. Our study sought to determine the interaction of frailty and age in elderly COVID-19 ICU patients. Methods A prospective multicentre study of COVID-19 patients ≥ 70 years admitted to intensive care in 138 ICUs from 28 countries was conducted. The primary endpoint was 30-day mortality. Frailty was assessed using the clinical frailty scale. Additionally, comorbidities, management strategies and treatment limitations were recorded. Results The study included 1346 patients (28% female) with a median age of 75 years (IQR 72–78, range 70–96), 16.3% were older than 80 years, and 21% of the patients were frail. The overall survival at 30 days was 59% (95% CI 56–62), with 66% (63–69) in fit, 53% (47–61) in vulnerable and 41% (35–47) in frail patients (p < 0.001). In frail patients, there was no difference in 30-day survival between different age categories. Frailty was linked to an increased use of treatment limitations and less use of mechanical ventilation. In a model controlling for age, disease severity, sex, treatment limitations and comorbidities, frailty was independently associated with lower survival. Conclusion Frailty provides relevant prognostic information in elderly COVID-19 patients in addition to age and comorbidities. Trial registration Clinicaltrials.gov: NCT04321265, registered 19 March 2020.
Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean difference of PaCO2 from baseline to 2 h (non-inferiority margin 10 mmHg) in the per-protocol analysis. Main secondary endpoints were non-inferiority of HFNT to NIV in reducing PaCO2 at 6 h in the per-protocol and intention-to-treat analysis and rate of treatment changes. Results Seventy-nine patients were analyzed (80 patients randomized). Mean differences for PaCO2 reduction from baseline to 2 h were − 6.8 mmHg (± 8.7) in the HFNT and − 9.5 mmHg (± 8.5) in the NIV group (p = 0.404). By 6 h, 32% of patients (13 out of 40) in the HFNT group switched to NIV and one to invasive ventilation. HFNT was statistically non-inferior to NIV since the 95% confidence interval (CI) upper boundary of absolute difference in mean PaCO2 reduction did not reach the non-inferiority margin of 10 mmHg (absolute difference 2.7 mmHg; 1-sided 95% CI 6.1; p = 0.0003). Both treatments had a significant effect on PaCO2 reductions over time, and trends were similar between groups. Similar results were found in both per-protocol at 6 h and intention-to-treat analysis. Conclusions HFNT was statistically non-inferior to NIV as initial ventilatory support in decreasing PaCO2 after 2 h of treatment in patients with mild-to-moderate AECOPD, considering a non-inferiority margin of 10 mmHg. However, 32% of patients receiving HFNT required NIV by 6 h. Further trials with superiority design should evaluate efficacy toward stronger patient-related outcomes and safety of HFNT in AECOPD. Trial registration: The study was prospectively registered on December 12, 2017, in ClinicalTrials.gov (NCT03370666).
Objectives: Assessing gas exchange, diaphragm function, respiratory rate, and patient comfort during high-flow oxygen therapy and standard oxygen at the time of noninvasive ventilation discontinuation. Design: Randomized crossover physiologic study. Setting: Two ICUs. Patients: Thirty chronic obstructive pulmonary disease patients with hypercapnic acute respiratory failure receiving noninvasive ventilation greater than 24 hours. Interventions: All patients underwent five 30-minute trials, the first, third, and fifth trial in noninvasive ventilation, whereas the second and fourth were randomly conducted with either standard oxygen and high-flow oxygen therapy. Measurements and Main Results: Diaphragm displacement and thickening fraction were determined by sonographic evaluation at the end of each trial. Arterial blood gases, respiratory rate, and patient comfort were also assessed. Paco 2 (p = 0.153) and pH (p = 0.114) were not different among trials, while Pao 2 was greater in noninvasive ventilation than with both standard oxygen (p ≤ 0.005) and high-flow oxygen therapy (p ≤ 0.001). The diaphragm displacement was no different among trials (p = 0.875), while its thickening fraction was greater with standard oxygen, compared with high-flow oxygen therapy and all noninvasive ventilation trials (p < 0.001 for all comparisons), without differences between high-flow oxygen therapy and noninvasive ventilation. Respiratory rate also increased with standard oxygen, compared with both high-flow oxygen therapy (p < 0.001) and noninvasive ventilation (p < 0.01). High-flow oxygen therapy improved comfort, compared with standard oxygen (p = 0.004) and noninvasive ventilation (p < 0.001). Conclusions: At the time of noninvasive ventilation interruption, Paco 2 and diaphragm displacement remained unchanged regardless of the modality of oxygen administration. However, although standard oxygen resulted in a remarkable increase in diaphragm thickening fraction, high-flow oxygen therapy allowed maintaining it unchanged, while improving patient comfort.
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