Erschienen in:
21.10.2018 | Seven-Day Profile Publication
A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2)
verfasst von:
Christophe Milési, Anne-Florence Pierre, Anna Deho, Robin Pouyau, Jean-Michel Liet, Camille Guillot, Anne-Sophie Guilbert, Jérôme Rambaud, Astrid Millet, Mickael Afanetti, Julie Guichoux, Mathieu Genuini, Thierry Mansir, Jean Bergounioux, Fabrice Michel, Marie-Odile Marcoux, Julien Baleine, Sabine Durand, Philippe Durand, Stéphane Dauger, Etienne Javouhey, Stéphane Leteurtre, Olivier Brissaud, Sylvain Renolleau, Aurélie Portefaix, Aymeric Douillard, Gilles Cambonie, for the GFRUP Respiratory Study Group
Erschienen in:
Intensive Care Medicine
|
Ausgabe 11/2018
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Abstract
Purpose
High-flow nasal cannula (HFNC) therapy is increasingly proposed as first-line respiratory support for infants with acute viral bronchiolitis (AVB). Most teams use 2 L/kg/min, but no study compared different flow rates in this setting. We hypothesized that 3 L/kg/min would be more efficient for the initial management of these patients.
Methods
A randomized controlled trial was performed in 16 pediatric intensive care units (PICUs) to compare these two flow rates in infants up to 6 months old with moderate to severe AVB and treated with HFNC. The primary endpoint was the percentage of failure within 48 h of randomization, using prespecified criteria of worsening respiratory distress and discomfort.
Results
From November 2016 to March 2017, 142 infants were allocated to the 2-L/kg/min (2L) flow rate and 144 to the 3-L/kg/min (3L) flow rate. Failure rate was comparable between groups: 38.7% (2L) vs. 38.9% (3L; p = 0.98). Worsening respiratory distress was the most common cause of failure in both groups: 49% (2L) vs. 39% (3L; p = 0.45). In the 3L group, discomfort was more frequent (43% vs. 16%, p = 0.002) and PICU stays were longer (6.4 vs. 5.3 days, p = 0.048). The intubation rates [2.8% (2L) vs. 6.9% (3L), p = 0.17] and durations of invasive [0.2 (2L) vs. 0.5 (3L) days, p = 0.10] and noninvasive [1.4 (2L) vs. 1.6 (3L) days, p = 0.97] ventilation were comparable. No patient had air leak syndrome or died.
Conclusion
In young infants with AVB supported with HFNC, 3 L/kg/min did not reduce the risk of failure compared with 2 L/kg/min. This clinical trial was recorded on the National Library of Medicine registry (NCT02824744).