• N. Engl. J. Med. · Nov 2022

    Randomized Controlled Trial Multicenter Study

    Spontaneous-Breathing Trials with Pressure-Support Ventilation or a T-Piece.

    • Arnaud W Thille, Arnaud Gacouin, Rémi Coudroy, Stephan Ehrmann, QuenotJean-PierreJPFrom Centre Hospitalier Universitaire (CHU) de Poitiers, Médecine Intensive Réanimation (A.W.T., R.C., J.-P.F.), and Institut National de la Santé et de la Recherche Médicale (INSERM) Centre d'Investigation Clinique (CIC) 1402, Investig, Mai-Anh Nay, Christophe Guitton, Damien Contou, Guylaine Labro, Jean Reignier, Gael Pradel, Gaëtan Beduneau, Laurence Dangers, Clement Saccheri, Gwénaël Prat, Guillaume Lacave, Nicholas Sedillot, Nicolas Terzi, Béatrice La Combe, Jean-Paul Mira, Antoine Romen, Marie-Ange Azais, Anahita Rouzé, Jérôme Devaquet, Agathe Delbove, Martin Dres, Jeremy Bourenne, Alexandre Lautrette, Joe de Keizer, Stéphanie Ragot, Jean-Pierre Frat, and REVA Research Network.
    • From Centre Hospitalier Universitaire (CHU) de Poitiers, Médecine Intensive Réanimation (A.W.T., R.C., J.-P.F.), and Institut National de la Santé et de la Recherche Médicale (INSERM) Centre d'Investigation Clinique (CIC) 1402, Investigations of Sleep, Acute Lung Injury, and Ventilation (IS-ALIVE), Université de Poitiers (A.W.T., R.C., J.K., S.R., J.-P.F.), Poitiers, CHU de Rennes, Hôpital Pontchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes (A.G.), Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, INSERM CIC 1415, Critical Research in Intensive Care and Sepsis-TriggerSep Research Network, and Centre d'Etude des Pathologies Respiratoires, INSERM U1100, Université de Tours, Tours (S.E.), CHU Dijon Bourgogne, Médecine Intensive Réanimation, INSERM CIC 1432, Université de Bourgogne Franche-Comté, Dijon (J.-P.Q.), Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans (M.-A.N.), Centre Hospitalier du Mans, Réanimation Médico-Chirurgicale, Le Mans (C.G.), Centre Hospitalier Victor Dupouy, Réanimation Polyvalente et Unité de Surveillance Continue, Argenteuil (D.C.), Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse (G. Labro), CHU de Nantes, Médecine Intensive Réanimation, Nantes (J.R.), Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac (G. Pradel), CHU de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, Université de Rouen UR3830, Rouen (G.B.), CHU Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion (L.D.), CHU de Nice, Réanimation Médicale Archet 1, UR2CA-Unité de Recherche Clinique Côte d'Azur, Université Côte d'Azur, Nice (C.S.), CHU de Brest, Médecine Intensive Réanimation, Brest (G. Prat), Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay (G. Lacave), Centre Hospitalier Fleyriat de Bourg-en-Bresse, Réanimation Polyvalente, Bourg-en-Bresse (N.S.), CHU Grenoble Alpes, Médecine Intensive Réanimation, INSERM U1042, HP2, Université Grenoble Alpes, Grenoble (N.T.), Centre Hospitalier Bretagne Sud, Réanimation Polyvalente, Lorient (B.L.C.), Assistance Publique-Hôpitaux de Paris (AP-HP), Groupe Hospitalier Paris Centre, Hôpital Cochin, Médecine Intensive Réanimation, Université Paris Cité, Institut Cochin, Centre National de la Recherche Scientifique (CNRS) Unité Mixte de Recherche (UMR) 8104, INSERM U1016 (J.-P.M.), and AP-HP, Groupe Hospitalier Universitaire AP-HP-Sorbonne Université, site Pitié-Salpêtrière, Service de Médecine Intensive-Réanimation, Département R3S (M.D.), Paris, Centre Hospitalier de Pau, Service de Réanimation, Pau (A. Romen), Centre Hospitalier Départemental de Vendée, Médecine Intensive Réanimation, La Roche Sur Yon (M.-A.A.), CHU de Lille, Médecine Intensive Réanimation, CNRS UMR 8576, INSERM U1285, Université de Lille, Lille (A. Rouzé), Hôpital Foch, Service de Réanimation Polyvalente, Suresnes (J.D.), Centre Hospitalier Bretagne Atlantique, Réanimation Polyvalente, Vannes (A.D.), Assistance Publique-Hôpitaux de Marseille, CHU La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille (J.B.), and Centre Jean Perrin, Unicancer, Service de Réanimation, Clermont-Ferrand (A.L.) - all in France.
    • N. Engl. J. Med. 2022 Nov 17; 387 (20): 184318541843-1854.

    BackgroundSpontaneous-breathing trials can be performed with the use of either pressure-support ventilation (PSV) or a T-piece. Whether PSV trials may result in a shorter time to tracheal extubation than T-piece trials, without resulting in a higher risk of reintubation, among patients who have a high risk of extubation failure is unknown.MethodsIn this multicenter, open-label trial, we randomly assigned patients who had a high risk of extubation failure (i.e., were >65 years of age or had an underlying chronic cardiac or respiratory disease) to undergo spontaneous-breathing trials performed with the use of either PSV (with a pressure-support level of 8 cm of water and no positive end-expiratory pressure) or a T-piece. The primary outcome was the total time without exposure to invasive ventilation (reported as the number of ventilator-free days) at day 28 after the initial spontaneous-breathing trial. Secondary outcomes included extubation within 24 hours and extubation within 7 days after the initial spontaneous-breathing trial, as well as reintubation within 7 days after extubation.ResultsA total of 969 patients (484 in the PSV group and 485 in the T-piece group) were included in the analysis. At day 28, the median number of ventilator-free days was 27 (interquartile range, 24 to 27) in the PSV group and 27 (interquartile range, 23 to 27) in the T-piece group (difference, 0 days; 95% confidence interval [CI], -0.5 to 1; P = 0.31). Extubation was performed within 24 hours in 376 patients (77.7%) in the PSV group and in 350 patients (72.2%) in the T-piece group (difference, 5.5 percentage points; 95% CI, 0.01 to 10.9), and extubation was performed within 7 days in 473 patients (97.7%) and 458 patients (94.4%), respectively (difference, 3.3 percentage points; 95% CI, 0.8 to 5.9). Reintubation was performed in 72 of 481 patients (14.9%) in the PSV group and in 65 of 477 patients (13.6%) in the T-piece group (difference, 1.3 percentage points; 95% CI, -3.1 to 5.8). Cardiac or respiratory arrest was a reason for reintubation in 9 patients (3 in the PSV group and 6 in the T-piece group).ConclusionsAmong patients who had a high risk of extubation failure, spontaneous-breathing trials performed with PSV did not result in significantly more ventilator-free days at day 28 than spontaneous-breathing trials performed with a T-piece. (Supported by the French Ministry of Health; TIP-EX ClinicalTrials.gov number, NCT04227639.).Copyright © 2022 Massachusetts Medical Society.

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