High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicent
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RESEARCH
High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non‑inferiority randomized trial Andrea Cortegiani1,2* , Federico Longhini3, Fabiana Madotto4, Paolo Groff5, Raffaele Scala6, Claudia Crimi7, Annalisa Carlucci8, Andrea Bruni3, Eugenio Garofalo3, Santi Maurizio Raineri1,2, Roberto Tonelli9, Vittoria Comellini10, Enrico Lupia11, Luigi Vetrugno12, Enrico Clini13, Antonino Giarratano1,2, Stefano Nava10, Paolo Navalesi14, Cesare Gregoretti1,15 and the H. F.-AECOPD study investigators
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 difference of P aCO2 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 P aCO2 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 P aCO2 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 P aCO2 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.
*Correspondence: [email protected] 1 Department of Surgical, Oncological and Oral Science (Di.Chir.On.S.), University of Palermo, Palermo, Italy Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Cre
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