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1. Multicentre observational status-epilepticus registry: Protocol for ICTAL

Author

Gwenaelle Jacq, Jonathan Chelly, Jean-Pierre Quenot, Pauline Soulier, Olivier Lesieur, Pascal Beuret, Mathilde Holleville, Cedric Bruel, Pierre Bailly, Bertrand Sauneuf, Caroline Sejourne, Jean Philippe Rigaud, Arnaud Galbois, Marine Arrayago, Gaetan Plantefeve, Annabelle Stoclin, David Schnell, Candice Fontaine, François Perier, Wulfran Bougouin, Nicolas Pichon, Nicolas Mongardon, Didier Ledoux, Jean-Baptiste Lascarrou, Stephane Legriel, Centre Hospitalier de Versailles André Mignot (CHV), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Groupe Hospitalier Sud, Groupe hospitalier de La Rochelle, Centre Hospitalier de Roanne, Hôpitaux Universitaires Paris Nord Val de Seine (HUPNVS), Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier Saint-Joseph [Paris], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service de Réanimation Polyvalente [CHPC - Site Louis Pasteur], Site Louis Pasteur [CHPC], CH Centre Hospitalier Public du Cotentin (CHPC)-CH Centre Hospitalier Public du Cotentin (CHPC), Centre Hospitalier de Béthune (CH Béthune), GHT de l'Artois, Centre hospitalier de Dieppe, Centre Hospitalier Privé Claude Galien - Ramsay Santé, Centre Hospitalier de Cannes, Centre hospitalier Argenteuil (CH Argenteuil), Institut Gustave Roussy (IGR), Département de soins aigus [Gustave Roussy] (DSA), Centre Hospitalier d'Angoulême (CH Angoulême), Hôpital Privé Jacques Cartier [Massy], Hôpital de Brive, Hôpital Henri Mondor, Centre Hospitalier Universitaire de Liège (CHU-Liège), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Acknowledgements We thank A Wolfe MD (Chaumont, France) for helping to prepare the manuscript. The study was supported by the French public funding agency Délégation à la Recherche Clinique et à l’Innovation (DRCI), Versailles, France., and HAL UVSQ, Équipe

Subjects
Critical Care, adult neurology, General Medicine, Cross-Sectional Studies, Status Epilepticus, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Humans, Multicenter Studies as Topic, Medicine, epidemiology, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Registries, adult intensive & critical care, Retrospective Studies
Abstract

IntroductionStatus epilepticus (SE) is a common life-threatening neurological emergency that can cause long-term impairments. Overall outcomes remain poor. Major efforts are required to clarify the epidemiology of SE and the determinants of outcomes, thereby identifying targets for improved management.Methods and analysisICTAL Registry is a multicentre open cohort of critically ill patients with convulsive, non-convulsive or psychogenic non-epileptic SE. Observational methods are applied to collect uniform data. The goal of the ICTAL Registry is to collect high-quality information on a large number of patients, thereby allowing elucidation of the pathophysiological mechanisms involved in mortality and morbidity. The registry structure is modular, with a large core data set and the opportunity for research teams to create satellite data sets for observational or interventional studies (eg, cohort multiple randomised controlled trials, cross-sectional studies and short-term and long-term longitudinal outcome studies). The availability of core data will hasten patient recruitment to studies, while also decreasing costs. Importantly, the vast amount of data from a large number of patients will allow valid subgroup analyses, which are expected to identify patient populations requiring specific treatment strategies. The results of the studies will have a broad spectrum of application, particularly given the multidisciplinary approach used by the IctalGroup research network.Ethics and disseminationThe ICTAL Registry protocol was approved by the ethics committee of the French Intensive Care Society (#CE_SRLF 19-68 and 19-68a). Patients or their relatives/proxies received written information to the use of the retrospectively collected and pseudonymised data, in compliance with French law. Prospectively included patients receive written consent form as soon as they recover decision-making competency; if they refuse consent, they are excluded from the registry. Data from the registry will be disseminated via conference presentations and peer-reviewed publications.Trial registration numberNCT03457831.

Published
2022
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2. Beneficial Effects of Non-Invasive Ventilation After Extubation in Obese or Overweight Patients : A Post-Hoc Analysis of a Randomized Clinical Trial

Author

Arnaud W. Thille, Rémi Coudroy, Mai-Anh Nay, Arnaud Gacouin, Maxens Decavèle, Romain Sonneville, François Beloncle, Christophe Girault, Laurence Dangers, Alexandre Lautrette, Quentin Levrat, Anahita Rouzé, Emmanuel Vivier, Jean-Baptiste Lascarrou, Jean-Damien Ricard, Armand Mekontso-Dessap, Guillaume Barberet, Christine Lebert, Stephan Ehrmann, Alexandre Massri, Jeremy Bourenne, Gael Pradel, Pierre Bailly, Nicolas Terzi, Jean Dellamonica, Guillaume Lacave, René Robert, Jean-Pierre Frat, Stéphanie Ragot, Florence Boissier, Delphine Chatellier, Céline Deletage, Carole Guignon, Florent Joly, Morgane Olivry, Anne Veinstein, Dalila Benzekri-Lefevre, Thierry Boulain, Grégoire Muller, Yves Le Tulzo, Jean-Marc Tadié, Adel Maamar, Suela Demiri, Julien Mayaux, Alexandre Demoule, Lila Bouadma, Claire Dupuis, Pierre Asfar, Marc Pierrot, Gaëtan Béduneau, Déborah Boyer, Benjamin Delmas, Bérénice Puech, Konstantinos Bachoumas, Edouard Soum, Séverin Cabasson, Marie-Anne Hoppe, Saad Nseir, Olivier Pouly, Gaël Bourdin, Sylvène Rosselli, Anthony Le Meur, Charlotte Garret, Maelle Martin, Guillaume Berquier, Abirami Thiagarajah, Guillaume Carteaux, Keyvan Razazi, Antoine Poidevin, Anne-Florence Dureau, Marie-Ange Azais, Gwenhaël Colin, Emmanuelle Mercier, Marlène Morisseau, Caroline Sabatier, Walter Picard, Marc Gainnier, Thi-My-Hue Nguyen, Gwenaël Prat, Carole Schwebel, Matthieu Buscot, Service de Médecine Intensive Réanimation [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), and Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Pulmonary and Respiratory Medicine, business.industry, Airway Extubation, Overweight, Critical Care and Intensive Care Medicine, Intensive care unit, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, 3. Good health, law.invention, 03 medical and health sciences, 0302 clinical medicine, 030228 respiratory system, Randomized controlled trial, law, Intensive care, Anesthesia, Post-hoc analysis, Breathing, medicine, 030212 general & internal medicine, medicine.symptom, Underweight, business, ComputingMilieux_MISCELLANEOUS
Abstract

RATIONALE Whereas non-invasive ventilation (NIV) may prevent reintubation in patients at high-risk of extubation failure in intensive care units (ICUs), this oxygenation strategy has not been specifically assessed in obese patients. OBJECTIVES We hypothesized that NIV may decrease the risk of reintubation in obese patients compared with high-flow nasal oxygen (HFNO). METHODS Post-hoc analysis of a multicenter, randomized, controlled trial (not pre-specified) comparing NIV alternating with HFNO versus HFNO alone after extubation, with the aim of assessing NIV effects according to patient body-mass index (BMI). MEASUREMENTS AND MAIN RESULTS Among 623 patients at high-risk of extubation failure, 206 (33%) were obese (BMI≥30 kg/m2), 204 (33%) were overweight (25≤BMI

Published
2021
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3. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial

Author

Stephan Ehrmann, Jie Li, Miguel Ibarra-Estrada, Yonatan Perez, Ivan Pavlov, Bairbre McNicholas, Oriol Roca, Sara Mirza, David Vines, Roxana Garcia-Salcido, Guadalupe Aguirre-Avalos, Matthew W Trump, Mai-Anh Nay, Jean Dellamonica, Saad Nseir, Idrees Mogri, David Cosgrave, Dev Jayaraman, Joan R Masclans, John G Laffey, Elsa Tavernier, Ahmad A Elshafei, Brady J Scott, Tyler Weiss, Ramandeep Kaur, Lauren J Harnois, Amanda Miller, Flor Cerda, Andrew Klein, Jacob R Burd, Kathleen Posa-Kearney, Matthew Trump, Julie Jackson, Trevor Oetting, Mark Greenwood, Lindsay Hazel, Lisa Kingery, Lindsey Morris, Joon Yong Moon, Julianne Garnett, Shijing Jia, Kristine Nelson, Camilla Giacomini, John Laffey, Aoife Brennan, Conor Judge, Maeve Kernan, Claire Kelly, Ritika Ranjan, Siobhan Casey, Kevin O'Connell, Evelyn Newell, David Gallagher, Alistair Nichol, Ger Curley, Miguel Ibarra Estrada, Roxana García-Salcido, Alexandra Vargas-Obieta, Sara A Aguirre-Díaz, Luz Alcántar-Vallín, Montserrat Alvarado-Padilla, Quetzalcóatl Chávez-Peña, José A López-Pulgarín, Julio C Mijangos-Méndez, Miguel Marín-Rosales, Jorge E García-Alvarado, Oscar G Baltazar-González, Maura C González-Guerrero, Paola G Gutiérrez Ramírez, Sean Gilman, Patrice Plamondon, Rachel Roy, Jason Shahin, Raham Ragoshai, Aasmine Kaur, Josie Campisi, Joseph Dahine, Stefanie Perron, Slimane Achouri, Ronald Racette, Anne Kulenkamp, Andrés Pacheco, Marina García-de-Acilu, Irene Dot, Laetitia Bodet-Contentin, Denis Garot, Emmanuelle Mercier, Charlotte Salmon Gandonnière, Marlène Morisseau, Youenn Jouan, Walid Darwiche, Annick Legras, Antoine Guillon, Pierre-François Dequin, Anne-Charlotte Tellier, Jean Reignier, Jean-Baptiste Lascarrou, Amélie Seguin, Luc Desmedt, Emmanuel Canet, Christophe Guitton, Rémy Marnai, Jean-Christophe Callahan, Mickaël Landais, Nicolas Chudeau, Cédric Darreau, Patrice Tirot, Marjorie Saint Martin, Charlene Le Moal, Grégoire Muller, Sophie Jacquier, Gwenaël Prat, Pierre Bailly, Nicola Ferrière, Arnaud W Thille, Jean-Pierre Frat, Clément Saccheri, Matthieu Buscot, Gaëtan Plantefève, Damien Contou, Damien Roux, Jean-Damien Ricard, Laura Federici, Noémie Zucman, Santiago Freita Ramos, Marc Amouretti, Sébastien Besset, Coralie Gernez, Agathe Delbove, Guillaume Voiriot, Alexandre Elabbadi, Muriel Fartoukh, Sébastien Préau, Raphaël Favory, Alexandre Pierre, Arnaud Sement, Nicolas Terzi, Florian Sigaud, Clara Candille, Emanuele Turbil, Julien Maizel, Clément Brault, Yoan Zerbib, Aurélie Joret, Cédric Daubin, Laurent Lefebvre, Alais Giraud, Adrien Auvet, Christophe Vinsonneau, Mehdi Marzouk, Jean-Pierre Quenot, Pascal Andreu, Marie Labruyère, Jean-Baptiste Roudaut, François Aptel, Alexandre Boyer, Philippe Boyer, Jean-Claude Lacherade, Hugo Hille, Marie Bouteloup, Matthieu Jeannot, Marc Feller, Guillaume Grillet, Bruno Levy, Antoine Kimmoun, Service de Médecine Intensive Réanimation [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d'Etude des Pathologies Respiratoires (CEPR), UMR 1100. Equipe 3 'Aérosolthérapie et biothérapies à visée respiratoire' (CEPR. Equipe 3), Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Adult, Pulmonary and Respiratory Medicine, Canada, medicine.medical_specialty, medicine.medical_treatment, medicine.disease_cause, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Patient Positioning, 03 medical and health sciences, 0302 clinical medicine, Correspondence, Prone Position, medicine, Humans, Intubation, Prospective Studies, 030212 general & internal medicine, Wakefulness, Mexico, ComputingMilieux_MISCELLANEOUS, SARS-CoV-2, business.industry, Incidence (epidemiology), Hazard ratio, COVID-19, United States, 3. Good health, Prone position, Treatment Outcome, 030228 respiratory system, Respiratory failure, Spain, Relative risk, Emergency medicine, Observational study, France, Respiratory Insufficiency, business, Ireland, Nasal cannula
Abstract

Summary Background Awake prone positioning has been reported to improve oxygenation for patients with COVID-19 in retrospective and observational studies, but whether it improves patient-centred outcomes is unknown. We aimed to evaluate the efficacy of awake prone positioning to prevent intubation or death in patients with severe COVID-19 in a large-scale randomised trial. Methods In this prospective, a priori set up and defined, collaborative meta-trial of six randomised controlled open-label superiority trials, adults who required respiratory support with high-flow nasal cannula for acute hypoxaemic respiratory failure due to COVID-19 were randomly assigned to awake prone positioning or standard care. Hospitals from six countries were involved: Canada, France, Ireland, Mexico, USA, Spain. Patients or their care providers were not masked to allocated treatment. The primary composite outcome was treatment failure, defined as the proportion of patients intubated or dying within 28 days of enrolment. The six trials are registered with ClinicalTrials.gov , NCT04325906 , NCT04347941 , NCT04358939 , NCT04395144 , NCT04391140 , and NCT04477655 . Findings Between April 2, 2020 and Jan 26, 2021, 1126 patients were enrolled and randomly assigned to awake prone positioning (n=567) or standard care (n=559). 1121 patients (excluding five who withdrew from the study) were included in the intention-to-treat analysis. Treatment failure occurred in 223 (40%) of 564 patients assigned to awake prone positioning and in 257 (46%) of 557 patients assigned to standard care (relative risk 0·86 [95% CI 0·75−0·98]). The hazard ratio (HR) for intubation was 0·75 (0·62−0·91), and the HR for mortality was 0·87 (0·68−1·11) with awake prone positioning compared with standard care within 28 days of enrolment. The incidence of prespecified adverse events was low and similar in both groups. Interpretation Awake prone positioning of patients with hypoxaemic respiratory failure due to COVID-19 reduces the incidence of treatment failure and the need for intubation without any signal of harm. These results support routine awake prone positioning of patients with COVID-19 who require support with high-flow nasal cannula. Funding Open AI inc, Rice Foundation, Projet Hospitalier de Recherche Clinique Interregional, Appel d'Offre 2020, Groupement Interregional de Recherche Clinique et d'Innovation Grand Ouest, Association pour la Promotion a Tours de la Reanimation Medicale, Fond de dotation du CHRU de Tours, Fisher & Paykel Healthcare Ltd.

Published
2021
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4. Inased (inhaled sedation in ICU) trial protocol: a multicentre randomised open-label trial

Author

Pierre-Yves Egreteau, Christophe Guitton, Erwan L'Her, Stephan Ehrmann, Emmanuel Nowak, Samir Jaber, Guillaume Grillet, Olivier Huet, Arnaud W. Thille, Florian Reizine, Pierre Bailly, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CH Morlaix, Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CIC Brest, Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Cavale Blanche, Laboratoire de Traitement de l'Information Medicale (LaTIM), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Institut National de la Santé et de la Recherche Médicale (INSERM)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), and Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT)-Centre Hospitalier Régional Universitaire de Brest (CHRU Brest)-Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM)

Subjects
medicine.medical_specialty, Sedation, medicine.medical_treatment, Trial protocol, delirium & cognitive disorders, Intravenous sedation, 03 medical and health sciences, 0302 clinical medicine, 030202 anesthesiology, Intensive care, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Multicenter Studies as Topic, Anesthesia, 030212 general & internal medicine, Prospective Studies, adult anaesthesia, adult intensive & critical care, Randomized Controlled Trials as Topic, Mechanical ventilation, business.industry, Ethics committee, Intensive Care, Delirium, General Medicine, Respiration, Artificial, 3. Good health, Intensive Care Units, Emergency medicine, Medicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, medicine.symptom, Open label, business
Abstract

IntroductionThe use of sedation in intensive care units (ICUs) is necessary and ubiquitous. The impact of sedation strategy on outcome, particularly when delivered early after initiation of mechanical ventilation, is unknown. Evidence is increasing that volatile anaesthetic agents could be associated with better outcome. Their use in delirium prevention is unknown.Methods and analysisThis study is an investigator-initiated, prospective, multicentre, two-arm, randomised, control, open-trial comparing inhaled sedation strategy versus intravenous sedation strategy in mechanically ventilated patients in ICU. Two hundred and fifty patients will be randomly assigned to the intravenous sedation group or inhaled sedation group, with a 1:1 ratio in two groups according to the sedation strategy. The primary outcome is the occurrence of delirium assessed using two times a day confusion assessment method for the ICU (CAM-ICU). Secondary outcomes include cognitive and functional outcomes at 3 and 12 months.Ethics and disseminationThe study has been approved by the Regional Ethics Committee (CPP Ouest) and national authorities (ANSM). The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT04341350

Published
2021
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5. Pressure-Support Ventilation vs T-Piece During Spontaneous Breathing Trials Before Extubation Among Patients at High Risk of Extubation Failure

Author

Alexandre Massri, Christine Lebert, Claire Dupuis, Carole Guignon, Konstantinos Bachoumas, Saad Nseir, Morgane Olivry, Maelle Martin, Keyvan Razazi, Alexandre Lautrette, Jean-Marc Tadié, Laurence Dangers, G. Barberet, Carole Schwebel, Pierre Bailly, Jean-Damien Ricard, Jeremy Bourenne, Maxens Decavèle, Guillaume Lacave, Thierry Boulain, Caroline Sabatier, Séverin Cabasson, Nicolas Terzi, Olivier Pouly, Thi-My-Hue Nguyen, Gael Bourdin, Matthieu Buscot, Florence Boissier, Suela Demiri, Arnaud Gacouin, Quentin Levrat, Charlotte Garret, Antoine Poidevin, Jean Dellamonica, René Robert, Gael Pradel, Anne-Florence Dureau, Dalila Benzekri-Lefevre, Rémi Coudroy, Benjamin Delmas, Abirami Thiagarajah, Romain Sonneville, Anahita Rouzé, Emmanuelle Mercier, Déborah Boyer, Christophe Girault, Lila Bouadma, Grégoire Muller, Marie-Ange Azais, Walter Picard, Emmanuel Vivier, Sylvène Rosselli, Mai-Anh Nay, Céline Deletage, Julien Mayaux, Adel Maamar, Anthony Le Meur, Pierre Asfar, Marie-Anne Hoppe, François Beloncle, Anne Veinstein, Guillaume Berquier, Alexandre Demoule, Marlène Morisseau, Marc Pierrot, Stéphanie Ragot, Edouard Soum, Gwenhael Colin, Gwenaël Prat, Bérénice Puech, Stephan Ehrmann, Florent Joly, Arnaud W. Thille, Delphine Chatellier, Jean-Pierre Frat, Jean-Baptiste Lascarrou, Marc Gainnier, Gaetan Beduneau, Armand Mekontso-Dessap, Guillaume Carteaux, Yves Le Tulzo, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Régional d'Orléans (CHRO), CHU Pontchaillou [Rennes], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU Rouen, Normandie Université (NU), Centre hospitalier Félix-Guyon [Saint-Denis, La Réunion], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand, Unité de Glycobiologie Structurale et Fonctionnelle UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Centre hospitalier Saint Joseph - Saint Luc [Lyon], Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Louis Mourier - AP-HP [Colombes], CHU Henri Mondor [Créteil], Centre Hospitalier Emile Muller [Mulhouse] (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier de Pau, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Henri Mondor d'Aurillac, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), CHU Grenoble, CHU Nice [Cimiez], Hôpital Cimiez [Nice] (CHU), Centre Hospitalier de Versailles André Mignot (CHV), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Recherche Agronomique (INRA)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), CHU Henri Mondor, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Pulmonary and Respiratory Medicine, airway extubation, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Pressure support ventilation, Airway Extubation, mechanical ventilation, Critical Care and Intensive Care Medicine, law.invention, Spontaneous breathing trial, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Interquartile range, law, Multicenter trial, Post-hoc analysis, medicine, 030212 general & internal medicine, Mechanical ventilation, business.industry, 3. Good health, 030228 respiratory system, Anesthesia, ICU, ventilator weaning, Cardiology and Cardiovascular Medicine, business
Abstract

Background Spontaneous breathing trial (SBT) using a T-piece remains the most frequently performed trial before extubation in ICUs. Research Question We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high risk of extubation failure. Study Design and Methods Post hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72 hours after initial SBT, that is, extubated after initial SBT and not reintubated within the following 72 hours. Results Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm H2O in median without positive end-expiratory pressure) in 243 patients (38%) and using a T-piece in 398 patients (62%). The proportion of patients successfully extubated 72 hours after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%; 95% CI, 2.8 to 28.1; P = .0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (P = .0002), whereas reintubation rates within the following 72 hours did not significantly differ (13% vs 10%, respectively; P = .4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted OR, 1.60; 95% CI, 1.30 to 2.18; P = .0061). Interpretation In patients at high risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.

Published
2020
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6. Non-invasive ventilation versus high-flow nasal cannula oxygen therapy with apnoeic oxygenation for preoxygenation before intubation of patients with acute hypoxaemic respiratory failure: a randomised, multicentre, open-label trial

Author

Jean-Pierre Frat, Jean-Damien Ricard, Jean-Pierre Quenot, Nicolas Pichon, Alexandre Demoule, Jean-Marie Forel, Jean-Paul Mira, Rémi Coudroy, Guillaume Berquier, Benoit Voisin, Gwenhaël Colin, Bertrand Pons, Pierre Eric Danin, Jérome Devaquet, Gwenael Prat, Raphaël Clere-Jehl, Franck Petitpas, Emmanuel Vivier, Keyvan Razazi, Mai-Anh Nay, Vincent Souday, Jean Dellamonica, Laurent Argaud, Stephan Ehrmann, Aude Gibelin, Christophe Girault, Pascal Andreu, Philippe Vignon, Laurence Dangers, Stéphanie Ragot, Arnaud W Thille, Delphine Chatellier, Florence Boissier, Anne Veinstein, René Robert, Céline Deletage-Métreau, Morgane Olivry, Claire Dahyot-Fizelier, Auguste Dargent, Audrey Large, Emmanuelle Begot, Claire Mancia, Maxence Decavele, Martin Dres, Samuel Lehingue, Laurent Papazian, Marine Paul, Nathalie Marin, Matthieu Le Meur, Mohammed Laissy, Anaita Rouzé, Saad Nseir, Matthieu Henry-Lagarrigue, Aihem Yehia, Frédéric Martino, Charles Cerf, Pierre Bailly, Julie Helms, Jean Baptiste Putegnat, Armand Mekontso-Dessap, Thierry Boulain, Pierre Asfar, Séverin Cabasson, Florent Wallet, Kada Klouche, Frédéric Bellec, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Université Sorbonne Paris Nord, Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre d'Investigation Clinique 1432 (Dijon) - Module Plurithématique : Périnatalité Cancérologie Handicap et Ophtalmologie (CIC-P803), Institut National de la Santé et de la Recherche Médicale (INSERM)-Direction Générale de l'Organisation des Soins (DGOS)-Université de Bourgogne (UB), Hôpital Dupuytren [CHU Limoges], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Charles Foix [AP-HP], Neurophysiologie Respiratoire Expérimentale et Clinique, Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Hôpital Nord [CHU - APHM], Aix Marseille Université (AMU), GHU AP-HP Centre Université de Paris, Hôpital Cochin [AP-HP], Université Paris Descartes - Paris 5 (UPD5), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, CHU Pointe-à-Pitre/Abymes [Guadeloupe], Centre Hospitalier Universitaire de Nice (CHU Nice), Centre méditerranéen de médecine moléculaire (C3M), Université Nice Sophia Antipolis (... - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Côte d'Azur (UCA), Hôpital Foch [Suresnes], Hôpital de la Cavale Blanche - CHRU Brest (CHU - BREST ), Nouvel Hôpital Civil de Strasbourg, Université de Strasbourg (UNISTRA), Les Hôpitaux Universitaires de Strasbourg (HUS), Centre hospitalier Saint Joseph - Saint Luc [Lyon], CHU Henri Mondor, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre Hospitalier Régional d'Orléans (CHRO), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Hospices Civils de Lyon (HCL), Hôpital Edouard Herriot [CHU - HCL], Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Pathologies Respiratoires : Protéolyse et Aérosolthérapie, Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Groupe de Recherche sur le Handicap Ventilatoire (GRHV), Institute for Research and Innovation in Biomedicine (IRIB), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-CHU Rouen, Normandie Université (NU), CHU Rouen, Centre d'Investigation Clinique de Limoges (CIC1435), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM), Delphine Chatellier, Florence Boissier, Anne Veinstein, René Robert, Céline Deletage-Métreau, Morgane Olivry, Claire Dahyot-Fizelier, Auguste Dargent, Audrey Large, Emmanuelle Begot, Claire Mancia, Maxence Decavele, Martin Dres, Samuel Lehingue, Laurent Papazian, Marine Paul, Nathalie Marin, Matthieu Le Meur, Mohammed Laissy, Anaita Rouzé, Saad Nseir, Matthieu Henry-Lagarrigue, Aihem Yehia, Frédéric Martino, Charles Cerf, Pierre Bailly, Julie Helms, Jean Baptiste Putegnat, Armand Mekontso-Dessap, Thierry Boulain, Pierre Asfar, Séverin Cabasson, Florent Wallet, Kada Klouche, Frédéric Bellec, Delphine Chatellier, Florence Boissier, Anne Veinstein, René Robert, Céline Deletage-Métreau, Morgane Olivry, Maxence Decavele, Martin Dres, Samuel Lehingue, Laurent Papazian, Matthieu Le Meur, Mohammed Laissy, Anaita Rouzé, Saad Nseir, Matthieu Henry-Lagarrigue, Aihem Yehia, Charles Cerf, Armand Mekontso-Dessap, Thierry Boulain, Pierre Asfar, CCSD, Accord Elsevier, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Université de Bourgogne (UB)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Université Nice Sophia Antipolis (1965 - 2019) (UNS), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de Réanimation, Hôpital Jean Bernard, CHU de Poitiers, Poitiers, France, Equipe LIPNESS (LNC - U1231) (LIPNESS), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Coordination des Prélèvements d’Organes et de Tissus (CHPOT), CHU Limoges, Service de Pneumologie et Réanimation Médicale [CHU Pitié-Salpêtrière] (Département ' R3S '), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-CHU Pitié-Salpêtrière [APHP], Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Laboratoire pluridisciplinaire de recherche en ingénierie des systèmes, mécanique et énergétique (PRISME), Université d'Orléans (UO)-Institut National des Sciences Appliquées - Centre Val de Loire (INSA CVL), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA), Centre d'Etudes Lasers Intenses et Applications (CELIA), Université de Bordeaux (UB)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre National de la Recherche Scientifique (CNRS), Service de Réanimation Médicale [Strasbourg], Institut universitaire des systèmes thermiques industriels (IUSTI), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Université Côte d'Azur (UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Réanimation Médicale [Hôpital de l’Archet], Centre Hospitalier Universitaire de Nice (CHU de Nice)-Hôpital de l'Archet, Service de Réanimation Médicale, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France, parent, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Limoges, Anti-infectieux : supports moléculaires des résistances et innovations thérapeutiques (RESINFIT), CHU Limoges-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM), Laboratoire de Génétique Chromosomique et Moléculaire [CHU Dijon], COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Université Côte d'Azur (UCA)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-IFR10, Normandie Université (NU)-Normandie Université (NU)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Rouen Normandie (UNIROUEN), and CHU Henri Mondor [Créteil]

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Nose, medicine.disease_cause, Catheterization, 03 medical and health sciences, 0302 clinical medicine, Fraction of inspired oxygen, Intensive care, Oxygen therapy, medicine, Intubation, Intratracheal, Intubation, Humans, Oximetry, Hypoxia, Noninvasive Ventilation, medicine.diagnostic_test, business.industry, Tracheal intubation, Oxygen Inhalation Therapy, 030208 emergency & critical care medicine, Middle Aged, Respiration, Artificial, 3. Good health, [SDV] Life Sciences [q-bio], Pulse oximetry, 030228 respiratory system, Respiratory failure, Anesthesia, Acute Disease, Female, business, Respiratory Insufficiency, Nasal cannula
Abstract

International audience; BACKGROUND: Non-invasive ventilation has never been compared with high-flow oxygen to determine whether it reduces the risk of severe hypoxaemia during intubation. We aimed to determine if preoxygenation with non-invasive ventilation was more efficient than high-flow oxygen in reducing the risk of severe hypoxaemia during intubation. METHODS: The FLORALI-2 multicentre, open-label trial was done in 28 intensive care units in France. Adult patients undergoing tracheal intubation for acute hypoxaemic respiratory failure (a partial pressure of arterial oxygen [PaO2] to fraction of inspired oxygen [FiO2] ratio of \textless/=300 mm Hg) were randomly assigned (1:1; block size, four participants) to non-invasive ventilation or high-flow oxygen during preoxygenation, with stratification by PaO2/FiO2 ratio (\textless/=200 mm Hg vs \textgreater200 mm Hg). Key exclusion criteria were intubation for cardiac arrest, altered consciousness (defined as a Glasgow coma score of less than eight points), other contraindications to non-invasive ventilation (recent laryngeal, oesophageal, or gastric surgery, and substantial facial fractures), pulse oximetry not available, pregnant or breastfeeding women, and refusal to participate. The primary outcome was the occurrence of severe hypoxaemia (pulse oximetry \textless80%) during the procedure, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02668458. FINDINGS: Between April 15, 2016, and Jan 8, 2017, 2079 patients were intubated in the 28 participating units, and 322 were enrolled. We excluded five patients with no recorded data, two who withdrew consent or were under legal protection, one who was not intubated, and one who had a cardiac arrest. Of the 313 patients included in the intention-to-treat analysis, 142 were assigned to non-invasive ventilation and 171 to high-flow oxygen therapy. Severe hypoxaemia occurred in 33 (23%) of 142 patients after preoxygenation with non-invasive ventilation and 47 (27%) of 171 with high-flow oxygen (absolute difference -4.2%, 95% CI -13.7 to 5.5; p=0.39). In the 242 patients with moderate-to-severe hypoxaemia (PaO2/FiO2 \textless/=200 mm Hg), severe hypoxaemia occurred less frequently after preoxygenation with non-invasive ventilation than with high-flow oxygen (28 [24%] of 117 patients vs 44 [35%] of 125; adjusted odds ratio 0.56, 0.32 to 0.99, p=0.0459). Serious adverse events did not differ between treatment groups, with the most common immediate complications being systolic arterial hypotension (70 [49%] patients in the non-invasive ventilation group vs 86 [50%] patients in the high-flow oxygen group) and chest infiltrate on x-ray (28 [20%] vs 33 [19%]), and the most common late complications being death at day 28 (53 [37%] vs 58 [34%]) and ventilator-associated pneumonia during ICU stay (31 [22%] vs 35 [20%]). INTERPRETATION: In patients with acute hypoxaemic respiratory failure, preoxygenation with non-invasive ventilation or high-flow oxygen therapy did not change the risk of severe hypoxaemia. Future research should explore the effect of preoxygenation method in patients with moderate-to-severe hypoxaemia at baseline. FUNDING: French Ministry of Health.

Published
2019
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7. Amiante et préjudice d’anxiété : pour une évolution de la jurisprudence

Author

Vericel, Marc, Pierre, Bailly, Véricel, Marc, Centre de Recherches Critiques sur le Droit (CERCRID), Centre National de la Recherche Scientifique (CNRS)-Université Jean Monnet [Saint-Étienne] (UJM)-Université Lumière - Lyon 2 (UL2), Cour de cassation [Paris], and Ministère de la Justice

Subjects
[SHS.DROIT]Humanities and Social Sciences/Law, [SHS.DROIT] Humanities and Social Sciences/Law, Santé au travail risques professionnels, Responsabilité, ComputingMilieux_MISCELLANEOUS
Abstract

National audience

Published
2019

8. Utilisation de l'EAD pour diminuer les frottements pédagogiques dans la mobilité internationale des étudiants. (L'expérience de la Faculté d'Economie de l'Université Pierre Mendès France de Grenoble)

Author

Jean-Louis Besson, Pierre Bailly, Laboratoire d'Economie de la Production et de l'Intégration Internationale (LEPII), Centre National de la Recherche Scientifique (CNRS)-Université Pierre Mendès France - Grenoble 2 (UPMF), and Ciesla, Catherine

Subjects
université, enseignement supérieur,étudiant,mobilité,université,France,Grenoble, enseignement supérieur, France, [SHS.ECO] Humanities and Social Sciences/Economics and Finance, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, étudiant, mobilité, Grenoble
Abstract

10 p.; La mobilité des étudiants, et surtout, la mobilité internationale demande aux universités de solutionner une multitude de problèmes de "tuyauterie" dans les deux sens (sortant et entrant) : - mise à disposition de l'information pertinente sur les universités et les conditions d'études et de vie locales ; - enregistrement, filtrage et régulation des candidatures sortantes (et, éventuellement, entrantes) ; - formalités administratives ; - préparation linguistique (et culturelle au sens large) des étudiants sortant et, dans l'autre sens, accueil des étudiants entrant. Ces problèmes sont compliqués mais les responsables et les personnels administratifs parviennent à en venir à bout. Il apparaît alors que la dimension pédagogique de la question ne se réduit pas à l'indispensable apprentissage linguistique.

Published
2008

9. L'EEES ou le développement de la compétition entre les établissements

Author

Pierre Bailly, Ciesla, Catherine, Laboratoire d'Economie de la Production et de l'Intégration Internationale (LEPII), and Centre National de la Recherche Scientifique (CNRS)-Université Pierre Mendès France - Grenoble 2 (UPMF)

Subjects
université, coopération, enseignement supérieur, accès à l'emploi, Union européenne, enseignement supérieur,accès à l'emploi,diplôme,Union européenne,université,coopération, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, [SHS.ECO] Humanities and Social Sciences/Economics and Finance, diplôme
Abstract

12 p.; L'Espace européen d'enseignement supérieur (EEES) constitue une rupture des schémas anciens en évaluant la qualité des diplômes par leur capacité à permettre des accès à des emplois. Deux enjeux principaux jouent un rôle majeur : d'une part constituer un espace européen de la formation débouchant sur un marché européen de l'emploi, d'autre part développer l'employabilité des jeunes formés dans les nouvelles technologies, condition de l'innovation et du développement de l'Europe dans une démarche qui est au fondement de la stratégie de Lisbonne. Le processus ne vise pas à aboutir à un ensemble homogène d'établissements indifférenciés mais à faciliter des échanges entre formations de même niveau. Cette démarche débouche sur la constitution d'un nouveau modèle des enseignements supérieurs fondé sur la confiance entre les partenaires.

Published
2008

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

Author

Arnaud W, Thille, Arnaud, Gacouin, Rémi, Coudroy, Stephan, Ehrmann, Jean-Pierre, Quenot, 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, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pathologies Respiratoires : Protéolyse et Aérosolthérapie, Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional d'Orléans (CHRO), Centre Hospitalier Le Mans (CH Le Mans), Centre Hospitalier Victor Dupouy, Centre Hospitalier Emile Muller [Mulhouse] (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Henri Mondor d'Aurillac, Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Groupe de Recherche sur le Handicap Ventilatoire et Neurologique (GRHVN), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre hospitalier Félix-Guyon [Saint-Denis, La Réunion], Centre Hospitalier Universitaire de Nice (CHU Nice), Unité de Recherche Clinique de la Côte d’Azur (URRIS UR2CA), Centre Hospitalier Universitaire de Nice (CHU Nice)-Université Côte d'Azur (UCA), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier de Versailles André Mignot (CHV), Centre Hospitalier Fleyriat [Bourg en Bresse], CHU Grenoble, Hypoxie et PhysioPathologie (HP2), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Groupe Hospitalier Bretagne Sud (GHBS), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier de Pau, Centre Hospitalier Loire Vendée Océan, CHU Lille, Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Hôpital Foch [Suresnes], Centre hospitalier Bretagne Atlantique (Morbihan) (CHBA), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Supported by a grant (18-007) from the Programme Hospitalier de Recherche Clinique National 2018 of the French Ministry of Health., REVA Research Network: Anne Veinstein, Delphine Chatellier, Florence Boissier, Maeva Rodriguez, Céline Deletage, Céline Abonneau, Adel Maamar, Florian Reizine, Jean-Marc Tadie, Charlotte Salmon-Gandonniere, Emmanuelle Mercier, Stefan Mankikian, Pascal Andreu, Marine Jacquier, Marie Labruyère, Dalila Benzekri-Lefevre, Grégoire Muller, Armelle Mathonnet, Nicolas Chudeau, Mickaël Landais, Cédric Darreau, Gaëtan Plantefève, Paul Desaint, Radj Cally, Pierre Oudeville, Valentin Pointurier, Yannick Rabouel, Gauthier Blonz, Maité Agbakou, Thi My-Hue Nguyen, Marie-Hélène Hausermann, Christophe Girault, Dorothée Carpentier, Chloé Combe, Amélie Renou, Jean Dellamonica, Lucas Morand, Pierre Bailly, Christelle Teiten, Marine Paul, Hugo Bellut, Clio Torres, Camille Bouisse, Guillaume Rigault, Louis-Marie Galerneau, Pierre Bouju, Roland Smoning, Driss Laghlam, Morgane Bertrix, Alexandre Massri, Ugo Gouedard, Saad Nseir, Benjamin Zuber, Yannick Fedun, Côme Bureau, Julien Carvelli, Guillaume Gayraud, Quentin Levrat, Emmanuel Vivier, Christophe Leroy, Laurent Argaud, Alexandre Demoule, Gaetan Beduneau, Jean Dellamonica, Claude Guerin, Samir Jaber, Armand Mekontso-Dessap, Alain Mercat, Saad Nseir, Jean Roeseler, Matthieu Schmidt, Nicolas Terzi, Arnaud W Thille, Unité de Recherche Clinique de la Côte d’Azur [Nice] (URRIS UR2CA), Université Côte d'Azur (UCA), and MORNET, Dominique

Subjects
Positive-Pressure Respiration, [SDV] Life Sciences [q-bio], Recurrence, Respiration, [SDV]Life Sciences [q-bio], Airway Extubation, Humans, General Medicine, Respiratory Insufficiency, Respiration, Artificial, Ventilator Weaning
Abstract

International audience; Background: Spontaneous-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.Methods: In 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.Results: A 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).Conclusions: Among 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.).

Published
2022
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