Frédéric Vargas1,2, Marc Clavel3, Pascale Sanchez-Verlan4, Sylvain Garnier5, Alexandre Boyer6, Hoang-Nam Bui6, Benjamin Clouzeau6, Charline Sazio6, Aissa Kerchache7, Olivier Guisset8, Antoine Benard9, Julien Asselineau9, Bernard Gauche10, Didier Gruson6, Stein Silva4,11, Philippe Vignon3, Gilles Hilbert6,12. 1. Service de Réanimation Médicale, Hôpital Pellegrin-Tripode, Centre Hospitalier Universitaire (CHU) de Bordeaux, 1 Place Amélie Raba-Léon, 33076, Bordeaux, France. frederic.vargas@chu-bordeaux.fr. 2. Centre de Recherche Cardio-Thoracique, INSERM 1045, CIC 0005, Université de Bordeaux, Bordeaux, France. frederic.vargas@chu-bordeaux.fr. 3. Service de Réanimation Polyvalente, CHU de Limoges, Hôpital Dupuytren, Limoges, France. 4. Service de Réanimation Polyvalente, CHU de Toulouse, Hôpital Purpan, Toulouse, France. 5. Service de Réanimation Polyvalente, Centre Hospitalier d'Albi, Albi, France. 6. Service de Réanimation Médicale, Hôpital Pellegrin-Tripode, Centre Hospitalier Universitaire (CHU) de Bordeaux, 1 Place Amélie Raba-Léon, 33076, Bordeaux, France. 7. Service de Réanimation Polyvalente, Centre Hospitalier d'Agen, Agen, France. 8. Service de Réanimation Médicale, CHU de Bordeaux, Hôpital Saint-André, Bordeaux, France. 9. Service d'Information Médicale, CHU de Bordeaux, Pôle de Santé Publique, USMR, Bordeaux, France. 10. Service de Réanimation Polyvalente, Centre Hospitalier de Libourne, Libourne, France. 11. INSERM, URM 1214, Université de Toulouse, Toulouse, France. 12. Centre de Recherche Cardio-Thoracique, INSERM 1045, CIC 0005, Université de Bordeaux, Bordeaux, France.
Abstract
PURPOSE:Early noninvasive ventilation (NIV) after extubation decreases the risk of respiratory failure and lowers 90-day mortality in patients with hypercapnia. Patients with chronic respiratory disease are at risk of extubation failure. Therefore, it could be useful to determine the role of NIV with a discontinuous approach, not limited to patients with hypercapnia. We assessed the efficacy of early NIV in decreasing respiratory failure after extubation in patients with chronic respiratory disorders. METHODS: A prospective randomized controlled multicenter study was conducted. We enrolled 144 mechanically ventilated patients with chronic respiratory disorders who tolerated a spontaneous breathing trial. Patients were randomly allocated after extubation to receive either NIV (NIV group, n = 72), performed with a discontinuous approach, for the first 48 h, or conventional oxygen treatment (usual care group, n = 72). The primary endpoint was decreased respiratory failure within 48 h after extubation. Analysis was by intention to treat. This trial was registered with ClinicalTrials.gov (NCT01047852). RESULTS:Respiratory failure after extubation was less frequent in the NIV group: 6 (8.5%) versus 20 (27.8%); p = 0.0016. Six patients (8.5%) in the NIV group versus 13 (18.1%) in the usual care group were reintubated; p = 0.09. Intensive care unit (ICU) mortality and 90-day mortality did not differ significantly between the two groups (p = 0.28 and p = 0.33, respectively). Median postrandomization ICU length of stay was lower in the usual care group: 3 days (IQR 2-6) versus 4 days (IQR 2-7; p = 0.008). Patients with hypercapnia during a spontaneous breathing trial were at risk of developing postextubation respiratory failure [adjusted odds ratio (95% CI) = 4.56 (1.59-14.00); p = 0.006] and being intubated [adjusted odds ratio (95% CI) = 3.60 (1.07-13.31); p = 0.04]. CONCLUSIONS: Early NIV performed following a sequential protocol for the first 48 h after extubation decreased the risk of respiratory failure in patients with chronic respiratory disorders. Reintubation and mortality did not differ between NIV and conventional oxygen therapy.
RCT Entities:
PURPOSE: Early noninvasive ventilation (NIV) after extubation decreases the risk of respiratory failure and lowers 90-day mortality in patients with hypercapnia. Patients with chronic respiratory disease are at risk of extubation failure. Therefore, it could be useful to determine the role of NIV with a discontinuous approach, not limited to patients with hypercapnia. We assessed the efficacy of early NIV in decreasing respiratory failure after extubation in patients with chronic respiratory disorders. METHODS: A prospective randomized controlled multicenter study was conducted. We enrolled 144 mechanically ventilated patients with chronic respiratory disorders who tolerated a spontaneous breathing trial. Patients were randomly allocated after extubation to receive either NIV (NIV group, n = 72), performed with a discontinuous approach, for the first 48 h, or conventional oxygen treatment (usual care group, n = 72). The primary endpoint was decreased respiratory failure within 48 h after extubation. Analysis was by intention to treat. This trial was registered with ClinicalTrials.gov (NCT01047852). RESULTS:Respiratory failure after extubation was less frequent in the NIV group: 6 (8.5%) versus 20 (27.8%); p = 0.0016. Six patients (8.5%) in the NIV group versus 13 (18.1%) in the usual care group were reintubated; p = 0.09. Intensive care unit (ICU) mortality and 90-day mortality did not differ significantly between the two groups (p = 0.28 and p = 0.33, respectively). Median postrandomization ICU length of stay was lower in the usual care group: 3 days (IQR 2-6) versus 4 days (IQR 2-7; p = 0.008). Patients with hypercapnia during a spontaneous breathing trial were at risk of developing postextubation respiratory failure [adjusted odds ratio (95% CI) = 4.56 (1.59-14.00); p = 0.006] and being intubated [adjusted odds ratio (95% CI) = 3.60 (1.07-13.31); p = 0.04]. CONCLUSIONS: Early NIV performed following a sequential protocol for the first 48 h after extubation decreased the risk of respiratory failure in patients with chronic respiratory disorders. Reintubation and mortality did not differ between NIV and conventional oxygen therapy.
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