Intermittent noninvasive ventilation after extubation in patients with chronic respiratory disorders: a multicenter randomized controlled trial (VHYPER)
- 2.5k Downloads
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.
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).
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].
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.
KeywordsNoninvasive ventilation Extubation failure Weaning Chronic respiratory disorder
We are grateful to the junior doctors, nursing staff, and our clinical research associate Marie-Pierre Baudier. We thank Patrick McSweeny for stylistic editing of the manuscript.
Compliance with ethical standards
This trial was supported and promoted by the French publicly funded hospital clinical research program (programme hospitalier de recherche clinique).
Conflicts of interest
The authors do not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript.
All procedures performed were in accordance with the ethical standards of our institutional research committee. An independent review board (Comité de protection des Personnes Sud-Ouest et Outre Mer III) approved the study.
Written informed consent was obtained from each patient or next of skin before inclusion.
- 14.Vargas F, Clavel M, Sanchez P, Garnier S, Boyer A, Bui HN, Kerchache A, Guisset A, Benard A, Asselineau J, Clouzeau B, Gruson D, Vignon P, Hilbert G (2012) Sequential and early used of noninvasive ventilation after extubation in patients with chronic respiratory disorders. Am J Respir Crit Care Med 185:A6487Google Scholar
- 15.Esteban A, Alia I, Gordo F, Fernandez R, Solsona JF, Vallverdu I, Macias S, Allegue J, Blanco J, Carriedo D, Leon M, Taboada F, Gonzalez de Velasco J, Palazon E, Carrizosa F, Tomas R, Suarez J, Goldwasser RS (1997) Extubation outcome after spontaneous breathing trials with T-Tube or pressure support ventilation. Am J Respir Crit Care Med 156:459–465CrossRefPubMedGoogle Scholar
- 17.Girault C, Bubenheim M, Abroug F, Diehl JL, Elatrous S, Beuret P, Richecoeur J, L’Her E, Hilbert G, Capellier G, Rabbat A, Besbes M, Guerin C, Guiot P, Benichou J, Bonmarchand G, VENISE Trial Group (2011) Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure. Am J Respir Crit Care Med 184:672–679CrossRefPubMedGoogle Scholar
- 20.Chiumello D, Polli F, Tallarini F, Chierichetti M, Motta G, Azzari S, Colombo R, Rech R, Pelosi P, Raimondi F, Gattinoni L (2007) Effect of different cycling-off criteria and positive end expiratory pressure during pressure support ventilation in patients with chronic obstructive pulmonary disease. Crit Care Med 35:2547–2552CrossRefPubMedGoogle Scholar
- 22.Gregoretti C, Confalonieri M, Navalesi P, Squadrone V, Frigerio P, Beltrame F, Carbone G, Conti G, Gamma F, Nava S, Calderini E, Skrobik Y, Antonelli M (2012) Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study. Intensive Care Med 28:278–284CrossRefGoogle Scholar
- 24.Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP (2017) Liberation from mechanical ventilation in critically ill alduts: On Official American College of Chest Physicians/American Thoracic Society clinical practice guideline: inspiratory pressure augmentation during spontaneous breathing trials, protocols minimizing sedation, and noninvasive ventilation immediately after extubation. Chest 151:166–180CrossRefPubMedGoogle Scholar
- 28.Thille AW, Boissier F, Ben-Ghezala H, Razazi K, Mekontso-Dessap A, Brun-Buisson C, Brochard L (2016) Easily identified at-risk patients for extubation failure may benefit from noninvasive ventilation: a prospective before-after study. Crit Care 20:48. doi: 10.1186/s13054-016-1228-2 CrossRefPubMedPubMedCentralGoogle Scholar
- 29.Keenan SP, Sinuff T, Burns KE, Muscedere J, Kutsogiannis J, Mehta S, Cook DJ, Ayas N, Adhikari NK, Hand L, Scales DC, Pagnotta R, Lazosky L, Rocker G, Dial S, Laupland K, Sanders K, Dodek P, Canadian Critical Care Trials Group/Canadian Critical Care Society Noninvasive Ventilation Guidelines Group (2011) Clinical practice guidelines for the use on noninvasive positive pressure ventilation and noninvasive continuous positive airway pressure in the acute care setting. CMAJ 183:E195–E214CrossRefPubMedPubMedCentralGoogle Scholar
- 33.Ornico SR, Lobo SM, Sanches HS, Deberaldini M, Tofoli LT, Vidal AM, Schettino GP, Amato MB, Carvalho CR, Barbas CS (2013) Noninvasive ventilation immediately after extubation improves weaning outcome after acute respiratory failure: a randomized controlled trial. Crit Care 17:R39CrossRefPubMedPubMedCentralGoogle Scholar
- 40.Hernandez G, Vaquero C, Gonzales P, Subira C, Fructos-Vivar F, Rialp G, Laborda C, Colinas L, Cuena R, Fernandez R (2016) Effects of postextubation high-flow nasal cannula vs conventional oxygen therapy on reintubation in low-risk patients A randomized clinical trial. JAMA 315:1354–1361CrossRefPubMedGoogle Scholar
- 41.Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez L, Villasclaras A, Fernandez R (2016) Effect of postextubation high-flow nasal cannula vs noninvasive ventilation on reintubation and postextubation respiratory failure in high-risk patients. A randomized clinical trial. JAMA 316:1565–1574CrossRefPubMedGoogle Scholar