Early extubation followed by immediate noninvasive ventilation vs. standard extubation in hypoxemic patients: a randomized clinical trial
Noninvasive ventilation (NIV) may facilitate withdrawal of invasive mechanical ventilation (i-MV) and shorten intensive care unit (ICU) length of stay (LOS) in hypercapnic patients, while data are lacking on hypoxemic patients. We aim to determine whether NIV after early extubation reduces the duration of i-MV and ICU LOS in patients recovering from hypoxemic acute respiratory failure.
Highly selected non-hypercapnic hypoxemic patients were randomly assigned to receive NIV after early or standard extubation. Co-primary end points were duration of i-MV and ICU LOS. Secondary end points were treatment failure, severe events (hemorrhagic, septic, cardiac, renal or neurologic episodes, pneumothorax or pulmonary embolism), ventilator-associated pneumonia (VAP) or tracheobronchitis (VAT), tracheotomy, percent of patients receiving sedation after study enrollment, hospital LOS, and ICU and hospital mortality.
We enrolled 130 consecutive patients, 65 treatments and 65 controls. Duration of i-MV was shorter in the treatment group than for controls [4.0 (3.0–7.0) vs. 5.5 (4.0–9.0) days, respectively, p = 0.004], while ICU LOS was not significantly different [8.0 (6.0–12.0) vs. 9.0 (6.5–12.5) days, respectively (p = 0.259)]. Incidence of VAT or VAP (9% vs. 25%, p = 0.019), rate of patients requiring infusion of sedatives after enrollment (57% vs. 85%, p = 0.001), and hospital LOS, 20 (13–32) vs. 27(18–39) days (p = 0.043) were all significantly reduced in the treatment group compared with controls. There were no significant differences in ICU and hospital mortality or in the number of treatment failures, severe events, and tracheostomies.
In highly selected hypoxemic patients, early extubation followed by immediate NIV application reduced the days spent on invasive ventilation without affecting ICU LOS.
KeywordsNoninvasive ventilation Hypoxemia Extubation Acute respiratory failure Weaning
Compliance with ethical standards
Conflicts of interest
Dr. Gregoretti received fees for consulting or lectures from Philips, Merdtronic, Resmed, Vivisol, Orion Pharma, and Origin. Dr. Cavuto received fees from Intersurgical S.p.A. Dr. Navalesi’s research laboratory has received equipment and grants from Maquet Critical Care, Draeger, and Intersurgical S.p.A. He also received honoraria/speaking fees from Maquet Critical Care, Orionpharma, Philips, Resmed, MSD, and Novartis. Dr Navalesi contributed to the development of the Next helmet, whose license for patent belongs to Intersurgical S.P.A., and receives royalties for that invention. Drs. Vaschetto, Longhini, Persona, Ori, Stefani, Liu, Yi, Lu, Yu, Luo, Tang, Li, Li, Cammarota, Bruni, Garofalo, Jin, Yan, Zheng, Yin, Guido, Della Corte, Fontana, Cortegiani, Giarratano, Montagnini, and Qiu declare that they do not have conflicts of interest.
All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.
- 1.Esteban A, Frutos-Vivar F, Muriel A, Ferguson ND, Penuelas O, Abraira V, Raymondos K, Rios F, Nin N, Apezteguia C, Violi DA, Thille AW, Brochard L, Gonzalez M, Villagomez AJ, Hurtado J, Davies AR, Du B, Maggiore SM, Pelosi P, Soto L, Tomicic V, D’Empaire G, Matamis D, Abroug F, Moreno RP, Soares MA, Arabi Y, Sandi F, Jibaja M, Amin P, Koh Y, Kuiper MA, Bulow HH, Zeggwagh AA, Anzueto A (2013) Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med 188:220–230CrossRefGoogle Scholar
- 4.Rochwerg B, Brochard L, Elliott MW, Hess D, Hill NS, Nava S, Navalesi PMOT, Antonelli M, Brozek J, Conti G, Ferrer M, Guntupalli K, Jaber S, Keenan S, Mancebo J, Mehta S, Raoof S Members Of The Task Force (2017) Official ERS/ATS clinical practice guidelines: noninvasive ventilation for acute respiratory failure. Eur Respir J 50:1602426. https://doi.org/10.1183/13993003.02426-2016 CrossRefGoogle Scholar
- 6.Jaber S, Lescot T, Futier E, Paugam-Burtz C, Seguin P, Ferrandiere M, Lasocki S, Mimoz O, Hengy B, Sannini A, Pottecher J, Abback PS, Riu B, Belafia F, Constantin JM, Masseret E, Beaussier M, Verzilli D, De JA, Chanques G, Brochard L, Molinari N (2016) Effect of noninvasive ventilation on tracheal reintubation among patients with hypoxemic respiratory failure following abdominal surgery: a randomized clinical trial. JAMA 315:1345–1353CrossRefGoogle Scholar
- 8.Vaschetto R, Turucz E, Dellapiazza F, Guido S, Colombo D, Cammarota G, Della CF, Antonelli M, Navalesi P (2012) Noninvasive ventilation after early extubation in patients recovering from hypoxemic acute respiratory failure: a single-centre feasibility study. Intensive Care Med 38:1599–1606CrossRefGoogle Scholar
- 10.Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R (2013) Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med 41:580–637CrossRefGoogle Scholar
- 13.Khwaja A (2012) KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract 120:c179–c184Google Scholar
- 15.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 (2011) Noninvasive ventilation and weaning in patients with chronic hypercapnic respiratory failure: a randomized multicenter trial. Am J Respir Crit Care Med 184:672–679CrossRefGoogle Scholar
- 16.Nava S, Ambrosino N, Clini E, Prato M, Orlando G, Vitacca M, Brigada P, Fracchia C, Rubini F (1998) Noninvasive mechanical ventilation in the weaning of patients with respiratory failure due to chronic obstructive pulmonary disease. A randomized, controlled trial. Ann Intern Med 128:721–728CrossRefGoogle Scholar
- 19.Lemiale V, Mokart D, Resche-Rigon M, Pene F, Mayaux J, Faucher E, Nyunga M, Girault C, Perez P, Guitton C, Ekpe K, Kouatchet A, Theodose I, Benoit D, Canet E, Barbier F, Rabbat A, Bruneel F, Vincent F, Klouche K, Loay K, Mariotte E, Bouadma L, Moreau AS, Seguin A, Meert AP, Reignier J, Papazian L, Mehzari I, Cohen Y, Schenck M, Hamidfar R, Darmon M, Demoule A, Chevret S, Azoulay E (2015) Effect of noninvasive ventilation vs oxygen therapy on mortality among immunocompromised patients with acute respiratory failure: a randomized clinical trial. JAMA 314:1711–1719CrossRefGoogle Scholar
- 20.Delclaux C, L’Her E, Alberti C, Mancebo J, Abroug F, Conti G, Guerin C, Schortgen F, Lefort Y, Antonelli M, Lepage E, Lemaire F, Brochard L (2000) Treatment of acute hypoxemic nonhypercapnic respiratory insufficiency with continuous positive airway pressure delivered by a face mask: a randomized controlled trial. JAMA 284:2352–2360CrossRefGoogle Scholar
- 23.Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R (2015) High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med 372:2185–2196CrossRefGoogle Scholar
- 24.Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De GA, Navalesi P, Antonelli M (2014) Nasal high-flow versus venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med 190:282–288CrossRefGoogle Scholar
- 25.Olivieri C, Longhini F, Cena T, Cammarota G, Vaschetto R, Messina A, Berni P, Magnani C, Della CF, Navalesi P (2016) New versus conventional helmet for delivering noninvasive ventilation: a physiologic, crossover randomized study in critically ill patients. Anesthesiology 124:101–108CrossRefGoogle Scholar
- 28.Nava S, Navalesi P, Carlucci A (2009) Non-invasive ventilation. Minerva Anestesiol 75:31–36Google Scholar