A Demoule1,2, M Clavel3, C Rolland-Debord4,5, S Perbet6,7, N Terzi8,9, A Kouatchet10, F Wallet11,12, H Roze13, F Vargas14, C Guerin15, J Dellamonica16,17, S Jaber18,19, L Brochard20,21, T Similowski4,5. 1. Service de Pneumologie et Réanimation Médicale (Département "R3S"), Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP, 75013, Paris, France. alexandre.demoule@aphp.fr. 2. Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France. alexandre.demoule@aphp.fr. 3. Réanimation Polyvalente, Hôpital Dupuytren, Limoges, France. 4. Service de Pneumologie et Réanimation Médicale (Département "R3S"), Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP, 75013, Paris, France. 5. Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France. 6. Réanimation Médico-Chirurgicale, CHU de Clermont-Ferrand, Clermont-Ferrand, France. 7. R2D2 EA-7281, Université d'Auvergne, Clermont-Ferrand, France. 8. INSERM U1042, Université Grenoble-Alpes, HP2, 38000, Grenoble, France. 9. Service de Réanimation Médicale, CHU Grenoble Alpes, 38000, Grenoble, France. 10. Service de Réanimation Médicale et Médecine Hyperbare, CHU d'Angers, Angers, Angers, France. 11. Réanimation Médicale et Chirurgicale, Centre Hospitalier Lyon-Sud, Lyon, France. 12. Laboratoire des Pathogènes Emergents, Centre International de Recherche en Infectiologie, Inserm U1111, CNRS UMR5308, ENS de Lyon, UCBL1, Lyon, France. 13. Anesthésie et Réanimation, CHU de Bordeaux, Pessac, France. 14. Réanimation Médicale, Hôpital Pellegrin-Tripode, Bordeaux, France. 15. Réanimation Médicale, Hôpital de la Croix Rousse, Lyon, France. 16. Réanimation Médicale, Hôpital de l'Archet, Centre Hospitalier Universitaire de Nice, Nice, France. 17. INSERM 1065 Team 3 C3 M, Nice, France. 18. Anesthésie et Réanimation, Hôpital Saint-Eloi, Montpellier, France. 19. Montpellier School of Medicine, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France. 20. Keenan Research Centre and Li Ka Shing Institute, Saint-Michael's Hospital, Toronto, ON, Canada. 21. Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada.
Abstract
PURPOSE:Neurally adjusted ventilatory assist (NAVA) is a ventilatory mode that tailors the level of assistance delivered by the ventilator to the electromyographic activity of the diaphragm. The objective of this study was to compare NAVA and pressure support ventilation (PSV) in the early phase of weaning from mechanical ventilation. METHODS: A multicentre randomized controlled trial of 128 intubated adults recovering from acute respiratory failure was conducted in 11 intensive care units. Patients were randomly assigned to NAVA or PSV. The primary outcome was the probability of remaining in a partial ventilatory mode (either NAVA or PSV) throughout the first 48 h without any return to assist-control ventilation. Secondary outcomes included asynchrony index, ventilator-free days and mortality. RESULTS: In the NAVA and PSV groups respectively, the proportion of patients remaining in partial ventilatory mode throughout the first 48 h was 67.2 vs. 63.3 % (P = 0.66), the asynchrony index was 14.7 vs. 26.7 % (P < 0.001), the ventilator-free days at day 7 were 1.0 day [1.0-4.0] vs. 0.0 days [0.0-1.0] (P < 0.01), the ventilator-free days at day 28 were 21 days [4-25] vs. 17 days [0-23] (P = 0.12), the day-28 mortality rate was 15.0 vs. 22.7 % (P = 0.21) and the rate of use of post-extubation noninvasive mechanical ventilation was 43.5 vs. 66.6 % (P < 0.01). CONCLUSIONS:NAVA is safe and feasible over a prolonged period of time but does not increase the probability of remaining in a partial ventilatory mode. However, NAVA decreases patient-ventilator asynchrony and is associated with less frequent application of post-extubation noninvasive mechanical ventilation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02018666.
RCT Entities:
PURPOSE: Neurally adjusted ventilatory assist (NAVA) is a ventilatory mode that tailors the level of assistance delivered by the ventilator to the electromyographic activity of the diaphragm. The objective of this study was to compare NAVA and pressure support ventilation (PSV) in the early phase of weaning from mechanical ventilation. METHODS: A multicentre randomized controlled trial of 128 intubated adults recovering from acute respiratory failure was conducted in 11 intensive care units. Patients were randomly assigned to NAVA or PSV. The primary outcome was the probability of remaining in a partial ventilatory mode (either NAVA or PSV) throughout the first 48 h without any return to assist-control ventilation. Secondary outcomes included asynchrony index, ventilator-free days and mortality. RESULTS: In the NAVA and PSV groups respectively, the proportion of patients remaining in partial ventilatory mode throughout the first 48 h was 67.2 vs. 63.3 % (P = 0.66), the asynchrony index was 14.7 vs. 26.7 % (P < 0.001), the ventilator-free days at day 7 were 1.0 day [1.0-4.0] vs. 0.0 days [0.0-1.0] (P < 0.01), the ventilator-free days at day 28 were 21 days [4-25] vs. 17 days [0-23] (P = 0.12), the day-28 mortality rate was 15.0 vs. 22.7 % (P = 0.21) and the rate of use of post-extubation noninvasive mechanical ventilation was 43.5 vs. 66.6 % (P < 0.01). CONCLUSIONS: NAVA is safe and feasible over a prolonged period of time but does not increase the probability of remaining in a partial ventilatory mode. However, NAVA decreases patient-ventilator asynchrony and is associated with less frequent application of post-extubation noninvasive mechanical ventilation. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02018666.
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