0000000000559716
AUTHOR
Vittoria Comellini
Additional file 1 of High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial
Additional file 1: Description of data: CONSORT (consolidated standards of reporting trials) Checklist for Non-inferiority and Equivalence Trials Checklist for Non-inferiority and Equivalence Trials.
High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial
Abstract 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 di…
Additional file 1: of High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents (DOC 122 kb)
Validation of Murray sputum purulence scale in the Italian Registry of Bronchiectasis (IRIDE)
Introduction: Murray sputum colour chart stratifies patients according to the presence of mucous (M), muco-purulent (MP) or purulent (P) sputum, and has not been validated in Bx yet. We aimed to validate this scale across a large Italian cohort of Bx patients. Methods: A secondary analysis of the IRIDE database was conducted including adults with Bx and daily sputum production enrolled across 13 Italian centres between 2014 and 2017. M vs. MP vs. P sputum producers were identified and clinical, functional and microbiological data were collected. Clinical outcomes during a two-year follow up period were evaluated in the Monza and Milan cohorts. A sensitivity analysis excluding COPD patients …
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
Background Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis. Methods We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial…
Additional file 2 of High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized trial
Additional file 2: Table S1: Characteristics of interventions in the high flow nasal therapy (HFNT) and noninvasive ventilation group (NIV); Table S2: Per-protocol 2 h. Patients’ characteristics in the noninvasive ventilation (NIV) and high flow nasal therapy (HFNT) groups at baseline; Table S3: Per-protocol 6 h. Patients’ characteristics in the noninvasive ventilation (NIV) and high flow nasal therapy (HFNT) groups at baseline; Figure S1: Absolute difference between HFNT and NIV treatment in mean PaCO2 reduction after 6 h (and 1-Sided 95% confidence interval), according to conducted analyses: intention-to-treat (ITT) and per-protocol on patients who completed the treatment originally alloc…
Quality standards for the management of bronchiectasis in Italy: A national audit
Although historically considered a neglected disease, bronchiectasis has become a disease of renewed interest over recent decades in light of an increase in prevalence and a substantial burden on healthcare systems. In 2010, the British Thoracic Society (BTS) published guidelines on the management of bronchiectasis in adults, along with specific quality standards. To date, these represent the only quality standards available in Europe. These have been tested over a number of years in the UK with progressive improvements in the standard of care. No national guidelines are available in Italy and no indications on which guideline should be followed have been given by the Italian Society of Res…