High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study)
- 26.01.2017
- Original
Erschienen in:
- Verfasst von
- Christophe Milési
- Sandrine Essouri
- Robin Pouyau
- Jean-Michel Liet
- Mickael Afanetti
- Aurélie Portefaix
- Julien Baleine
- Sabine Durand
- Clémentine Combes
- Aymeric Douillard
- Gilles Cambonie
- Groupe Francophone de Réanimation et d’Urgences Pédiatriques (GFRUP)
- Erschienen in
- Intensive Care Medicine | Ausgabe 2/2017
Abstract
Purpose
Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants.
Methods
A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH2O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events.
Results
From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of −19% (95% CI −35 to −3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02–2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died.
Conclusion
In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013).
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- Titel
- High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study)
- Verfasst von
-
Christophe Milési
Sandrine Essouri
Robin Pouyau
Jean-Michel Liet
Mickael Afanetti
Aurélie Portefaix
Julien Baleine
Sabine Durand
Clémentine Combes
Aymeric Douillard
Gilles Cambonie
Groupe Francophone de Réanimation et d’Urgences Pédiatriques (GFRUP)
- Publikationsdatum
- 26.01.2017
- Verlag
- Springer Berlin Heidelberg
- Erschienen in
-
Intensive Care Medicine / Ausgabe 2/2017
Print ISSN: 0342-4642
Elektronische ISSN: 1432-1238 - DOI
- https://doi.org/10.1007/s00134-016-4617-8
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