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3. Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Author

Jean-François Timsit, Damien Contou, Julien Schmidt, Carine Roy, Romain Sonneville, Lila Bouadma, Armand Mekontso Dessap, Michel Djibré, Camille Couffignal, Juliette Audibert, Pierre Jaquet, Virginie Godard, Romane Bellot, Fariza Lamara, Tchoubou Tona, Florian Sigaud, Adam Celier, Claire Bourel, Fatiha Essardy, Renaud Cornic, ABGRALL Gwenole, ARRESTIER Romain, AUDIBERT Juliette, AUGY Jean loup, BAGATE François, BAY Pierre, BEGOT Erwan, BEN SALAH Adel, BENELLI Brice, BERTI Enora, BERTIER Astrid, BEURTON Alexandra, BILLIET Pierre-Antoine, BOUADMA Lila, BOUGNAUD Joanna, BOUILLAND Anne Laure, BOUJELBEN Mohamed, BUREAU Côme, CANDILLE Clara, CARIOU Erwann, CARTEAUX Guillaume, CATANO Jenifer, CAVALEIRO Pedro, CELIER Adam, CHAFIOTTE Pierre, CIRILLO Giulia, CLERC Sébastien, CONIA Alexandre, CORDIER Charlotte, COUPRY Louis-Marie, DA SILVA Daniel, DARTEVEL Anais, DE MONTMOLLIN Etienne, DE MONTMOLLIN Nina, DE PROST Nicolas, DECAVELE Maxens, DELERIS Robin, DEMOULE Alexandre, DESNOS Cyrielle, DESSAJAN Julien, DIEMOZ Marie-Claire, DO REGO Hermann, DO VALE Julien, DRES Martin, DUFRANC Etienne, EJZENBERG Michael, ELABBADI Alexandre, FLOCH Pierre Edouard, FOSSE Quentin, FRAPARD Thomas, GAILLET Antoine, GALERNEAU Louis-Marie, GENDREAU Ségolène, GONCALVES CAVALEIRO Pedro, GONTIER Olivier, HAMROUNI Mouldi, HAUDEBOURG Anne-Fleur, HAUDEBOURG Luc, JOLLY Florian, LA MAREC Julien, LABEDADE Pascale, LAVILLEGRAND Jean-Rémi, LECRONIER Marie, LOPINTO Julien, MASI Paul, MAYAUX Julien, MENAT Sophie, MONCOMBLE Elsa, MORAWIEC Elise, NAGLE Sophie, NEMLAGHI Safaa, PICARD Benjamin, PICHON Jeremie, PLAIS Henri, RAZAZI Keyvan, RIGAULT Guillaume, SIGAUD Florian, SONNEVILLE Romain, THY Michael, TIMSIT Jean-François, TUFFET Samuel, TURPIN Matthieu, VINCENT Xavier, VOIRIOT Guillaume, WICKY Paul-Henri, and WINDSOR Camille

Subjects
Medicine
Abstract

Introduction Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.Methods and analysis The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.Ethics and dissemination The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.Trial registration number NCT04273360.

Published
2024
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5. Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial

Author

BOURDIN, Gaël, VIVIER, Emmanuel, LARGE, Audrey, DONZE, Pierre, BOUZGARROU, Radhia, PERINEL RAGEY, Sophie, CHAUDIER, Caroline, DESEBBE, Olivier, FOLLIET, Laure, CHAUVELOT, Louis, CHABERT, Paul, DAVID, Guillaume, DANJOU, William, BETTINGER, Clotilde, BERNON, Pauline, DHELFT, Francois, COUR, Martin, SIMON, Marie, BAUDRY, Thomas, RIMMELE, Thomas, CARABALONA, Jean-François, GREGOIRE, Arnaud, FRIGGERI, Arnaud, DE-MARIGNAN, Donatien, ROCHE, Sylvain, Richard, Jean-Christophe, Terzi, Nicolas, Yonis, Hodane, Chorfa, Fatima, Wallet, Florent, Dupuis, Claire, Argaud, Laurent, Delannoy, Bertrand, Thiery, Guillaume, Pommier, Christian, Abraham, Paul, Muller, Michel, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Souweine, Bertrand, Baboi, Loredana, Serrier, Hassan, Rabilloud, Muriel, and Bitker, Laurent

Published
2023
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6. Effect of non-invasive ventilation after extubation in critically ill patients with obesity in France: a multicentre, unblinded, pragmatic randomised clinical trial

Author

DE JONG, AUDREY, BIGNON, ANNE, STEPHAN, FRANÇOIS, GODET, THOMAS, CONSTANTIN, JEAN-MICHEL, ASEHNOUNE, KARIM, SYLVESTRE, AUDE, SAUTILLET, JULIETTE, BLONDONNET, RAIKO, FERRANDIERE, MARTINE, SEGUIN, PHILIPPE, LASOCKI, SIGISMOND, ROLLE, AMELIE, FAYOLLE, PIERRE-MARIE, MULLER, LAURENT, PARDO, EMMANUEL, TERZI, NICOLAS, RAMIN, SEVERIN, JUNG, BORIS, ABBACK, PAER-SELIM, GUERCI, PHILIPPE, SARTON, BENJAMINE, ROZE, HADRIEN, DUPUIS, CLAIRE, COUSSON, JOEL, FAUCHER, MARION, LEMIALE, VIRGINIE, CHOLLEY, BERNARD, CHANQUES, GERALD, BELAFIA, FOUAD, HUGUET, HELENA, FUTIER, EMMANUEL, GNIADEK, CLAUDINE, VONARB, AURELIE, PRADES, ALBERT, JAILLET, CARINE, CAPDEVILA, XAVIER, CHARBIT, JONATHAN, GENTY, THIBAUT, REZAIGUIA-DELCLAUX, SAIDA, IMBERT, AUDREY, PILORGE, CATHERINE, CALYPSO, ROMAN, BOUTEAU-DURAND, ASTRID, CARLES, MICHEL, MEHDAOUI, HOSSEN, SOUWEINE, BERTRAND, CALVET, LAURE, JABAUDON, MATTHIEU, RIEU, BENJAMIN, CANDILLE, CLARA, SIGAUD, FLORIAN, RIU, BEATRICE, PAPAZIAN, LAURENT, VALERA, SABINE, MOKART, DJAMEL, CHOW CHINE, LAURENT, BISBAL, MAGALI, POULIQUEN, CAMILLE, DE GUIBERT, JEAN-MANUEL, TOURRET, MAXIME, MALLET, DAMIEN, LEONE, MARC, ZIELESKIEWICZ, LAURENT, COSSIC, JEANNE, ASSEFI, MONA, BARON, ELODIE, QUEMENEUR, CYRIL, MONSEL, ANTOINE, BIAIS, MATTHIEU, OUATTARA, ALEXANDRE, BONNARDEL, ELINE, MONZIOLS, SIMON, MAHUL, MARTIN, LEFRANT, JEAN-YVES, ROGER, CLAIRE, BARBAR, SABER, LAMBIOTTE, FABIEN, SAINT-LEGER, PIEHR, PAUGAM, CATHERINE, POTTECHER, JULIEN, LUDES, PIERRE-OLIVIER, DARRIVERE, LUCIE, GARNIER, MARC, KIPNIS, ERIC, LEBUFFE, GILLES, GAROT, MATTHIAS, FALCONE, JEREMY, CHOUSTERMAN, BENJAMIN, COLLET, MAGALI, GAYAT, ETIENNE, DELLAMONICA, JEAN, MFAM, WILLY-SERGE, OCHIN, EVELINA, NEBLI, MOHAMED, TILOUCHE, NEJLA, MADEUX, BENJAMIN, BOUGON, DAVID, AARAB, YASSIR, GARNIER, FANNY, AZOULAY, ELIE, MOLINARI, NICOLAS, JABER, SAMIR, De Jong, Audrey, Bignon, Anne, Stephan, François, Godet, Thomas, Constantin, Jean-Michel, Asehnoune, Karim, Sylvestre, Aude, Sautillet, Juliette, Blondonnet, Raiko, Ferrandière, Martine, Seguin, Philippe, Lasocki, Sigismond, Rollé, Amélie, Fayolle, Pierre-Marie, Muller, Laurent, Pardo, Emmanuel, Terzi, Nicolas, Ramin, Séverin, Jung, Boris, Abback, Paer-Selim, Guerci, Philippe, Sarton, Benjamine, Rozé, Hadrien, Dupuis, Claire, Cousson, Joel, Faucher, Marion, Lemiale, Virginie, Cholley, Bernard, Chanques, Gerald, Belafia, Fouad, Huguet, Helena, Futier, Emmanuel, Azoulay, Elie, Molinari, Nicolas, and Jaber, Samir

Published
2023
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8. Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Published
2022
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10. Awake prone positioning for COVID-19 acute hypoxaemic respiratory failure: a randomised, controlled, multinational, open-label meta-trial

Author

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

Published
2021
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11. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Published
2021
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12. Phenotypes of functional CT imagining predict clinical outcome in ARDS patients

Author

Shekarnabi, Mehdi, primary, Sigaud, Florian, additional, Gaillet, Maxime, additional, Guillien, Alicia, additional, Roux, Emmanuel, additional, Ahaouari, Touria, additional, Davila, Edouardo, additional, Boussel, Loic, additional, Ferretti, Gilbert, additional, Yonis, Hodane, additional, Mezidi, Mehdi, additional, Danjou, William, additional, Bazzani, Alwin, additional, Dhelft, François, additional, Folliet, Laure, additional, Girard, Mehdi, additional, Siroux, Valérie, additional, Bitker, Laurent, additional, Terzi, Nicolas, additional, Orkisz, Maciej, additional, Richard, Jean-Christophe, additional, and Bayat, Sam, additional

Published
2023
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13. Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial

Author

Richard, Jean-Christophe, primary, Terzi, Nicolas, additional, Yonis, Hodane, additional, Chorfa, Fatima, additional, Wallet, Florent, additional, Dupuis, Claire, additional, Argaud, Laurent, additional, Delannoy, Bertrand, additional, Thiery, Guillaume, additional, Pommier, Christian, additional, Abraham, Paul, additional, Muller, Michel, additional, Sigaud, Florian, additional, Rigault, Guillaume, additional, Joffredo, Emilie, additional, Mezidi, Mehdi, additional, Souweine, Bertrand, additional, Baboi, Loredana, additional, Serrier, Hassan, additional, Rabilloud, Muriel, additional, Bitker, Laurent, additional, BOURDIN, Gaël, additional, VIVIER, Emmanuel, additional, LARGE, Audrey, additional, DONZE, Pierre, additional, BOUZGARROU, Radhia, additional, PERINEL RAGEY, Sophie, additional, CHAUDIER, Caroline, additional, DESEBBE, Olivier, additional, FOLLIET, Laure, additional, CHAUVELOT, Louis, additional, CHABERT, Paul, additional, DAVID, Guillaume, additional, DANJOU, William, additional, BETTINGER, Clotilde, additional, BERNON, Pauline, additional, DHELFT, Francois, additional, COUR, Martin, additional, SIMON, Marie, additional, BAUDRY, Thomas, additional, RIMMELE, Thomas, additional, CARABALONA, Jean-François, additional, GREGOIRE, Arnaud, additional, FRIGGERI, Arnaud, additional, DE-MARIGNAN, Donatien, additional, and ROCHE, Sylvain, additional

Published
2023
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16. Corticosteroids for severe acute exacerbations of chronic obstructive pulmonary disease in intensive care: From the French OUTCOMEREA cohort.

Author

Galerneau, Louis Marie, Bailly, Sébastien, Terzi, Nicolas, Ruckly, Stéphane, Garrouste-Orgeas, Maïté, Cohen, Yves, Hong Tuan Ha, Vivien, Gainnier, Marc, Siami, Shidasp, Dupuis, Claire, Darmon, Michael, Azoulay, Elie, Forel, Jean-Marie, Sigaud, Florian, Adrie, Christophe, Goldgran-Toledano, Dany, Ferré, Alexis, de Montmollin, Etienne, Argaud, Laurent, and Reignier, Jean

Subjects
CHRONIC obstructive pulmonary disease, DISEASE exacerbation, CRITICAL care medicine, ADRENERGIC beta agonists, INTENSIVE care units, LENGTH of stay in hospitals
Abstract

Introduction: Acute exacerbation of chronic obstructive pulmonary disease (COPD) is a frequent cause of intensive care unit (ICU) admission. However, data are scarce and conflicting regarding the impact of systemic corticosteroid treatment in critically ill patients with acute exacerbation of COPD. The aim of the study was to assess the impact of systemic corticosteroids on the occurrence of death or need for continuous invasive mechanical ventilation at day 28 after ICU admission. Methods: In the OutcomeReaTM prospective French national ICU database, we assessed the impact of corticosteroids at admission (daily dose ≥ 0.5 mg/kg of prednisone or equivalent during the first 24 hours ICU stay) on a composite outcome (death or invasive mechanical ventilation) using an inverse probability treatment weighting. Results: Between January 1, 1997 and December 31, 2018, 391 out of 1,247 patients with acute exacerbations of COPDs received corticosteroids at ICU admission. Corticosteroids improved the main composite endpoint (OR = 0.70 [0.49; 0.99], p = 0.044. However, for the subgroup of most severe COPD patients, this did not occur (OR = 1.12 [0.53; 2.36], p = 0. 770). There was no significant impact of corticosteroids on rates of non-invasive ventilation failure, length of ICU or hospital stay, mortality or on the duration of mechanical ventilation. Patients on corticosteroids had the same prevalence of nosocomial infections as those without corticosteroids, but more glycaemic disorders. Conclusion: Using systemic corticosteroids for acute exacerbation of COPD at ICU admission had a positive effect on a composite outcome defined by death or need for invasive mechanical ventilation at day 28. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Additional file 1 of Early prone positioning in acute respiratory distress syndrome related to COVID-19: a propensity score analysis from the multicentric cohort COVID-ICU network���the ProneCOVID study

Author

Le Terrier, Christophe, Sigaud, Florian, Lebbah, Said, Desmedt, Luc, Hajage, David, Gu��rin, Claude, Pugin, J��r��me, Primmaz, Steve, and Terzi, Nicolas

Subjects
respiratory system, circulatory and respiratory physiology, respiratory tract diseases
Abstract

Additional file 1. Additional information about the baseline characteristics and the statistical analysis (file format in .docx). Additional Tables and Figures. Table S1. Distribution of patients per region included in this study according to their prone position status at Day-1. Table S2. Descriptive analysis of baseline population included in propensity score analysis and complete case population. Table S3. Descriptive analysis of baseline characteristics before and after weighted-propensity score analysis. Fig. S1. Adjustment quality before and after propensity score analysis. Table S4. Descriptive subgroup analysis of baseline population with PaO2/FiO2 ratio < 150 mmHg at Day-1 included in propensity score analysis and complete case population. Table S5. Descriptive subgroup analysis of baseline population characteristics with PaO2/FiO2 ratio < 150 mmHg at Day-1 before and after weighted-propensity score analysis. Fig. S2. Adjustment quality before and after propensity score analysis in the subgroup of patients with PaO2/FiO2 ratio < 150 mmHg at Day-1. Fig. S3. a Kaplan���Meier curves according to prone status in ICU at Day-1 before weighting adjustment in complete case subgroup population with PaO2/FiO2 ratio < 150 mmHg. b Kaplan���Meier curves according to prone status in ICU at Day-1 after weighting adjustment in complete case subgroup population with PaO2/FiO2 < 150 mmHg. Fig. S4. a Forest plot: Hazard Ratio according to prone status in ICU at Day-1 before and after weighting in complete case subgroup population with PaO2/FiO2 ratio < 150 mmHg. b Hazard Ratio according to prone status in ICU at Day-1 before and after weighting in baseline subgroup population with PaO2/FiO2 ratio < 150 mmHg. Table S6. Descriptive subgroup analysis of baseline population with PaO2/FiO2 ratio > 150 mmHg included in propensity score analysis and complete case population. Table S7. Descriptive subgroup analysis of baseline population characteristics with PaO2/FiO2 ratio > 150 mmHg at Day-1 before and after weighted-propensity score analysis. Fig. S5. Adjustment quality before and after propensity score analysis in the subgroup of patients with PaO2/FiO2 ratio > 150 mmHg at Day-1. Fig. S6. a Kaplan���Meier curves according to prone status in ICU at Day-1 before weighting adjustment in complete case subgroup population with PaO2/FiO2 ratio > 150 mmHg. b Kaplan���Meier curves according to prone status in ICU at Day-1 after weighting adjustment in complete case subgroup population with PaO2/FiO2 ratio > 150 mmHg. Fig. S7. a Forest plot: Hazard Ratio according to prone status in ICU at Day-1 before and after weighting in complete case subgroup population with PaO2/FiO2 ratio > 150 mmHg. b Hazard Ratio according to prone status in ICU at Day-1 before and after weighting in baseline subgroup population with PaO2/FiO2 ratio > 150 mmHg.

Published
2022
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18. Additional file 2 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Subjects
ComputingMilieux_GENERAL, Data_FILES
Abstract

Additional file 2: Flow chart of the study

Published
2022
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19. Additional file 3 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Subjects
Hardware_MEMORYSTRUCTURES, Data_FILES
Abstract

Additional file 3: Missing data per variable

Published
2022
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20. Additional file 4 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Abstract

Additional file 4: Sensitivity analysis

Published
2022
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21. Additional file 1 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Abstract

Additional file 1: Computation of compliance of the already aerated lung at PEEP 5 (CBABY LUNG)

Published
2022
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22. Additional file 5 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Subjects
respiratory system, respiratory tract diseases
Abstract

Additional file 5: Univariate analysis of variables associated with lung recruitment

Published
2022
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23. Additional file 7 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Subjects
respiratory system, respiratory tract diseases
Abstract

Additional file 7: Univariate and multivariate analyses of variables associated with CBABY LUNG

Published
2022
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24. Additional file 6 of Response to PEEP in COVID-19 ARDS patients with and without extracorporeal membrane oxygenation. A multicenter case–control computed tomography study

Author

Richard, Jean-Christophe, Sigaud, Florian, Gaillet, Maxime, Orkisz, Maciej, Bayat, Sam, Roux, Emmanuel, Ahaouari, Touria, Davila, Eduardo, Boussel, Loic, Ferretti, Gilbert, Yonis, Hodane, Mezidi, Mehdi, Danjou, William, Bazzani, Alwin, Dhelft, Francois, Folliet, Laure, Girard, Mehdi, Pozzi, Matteo, Terzi, Nicolas, and Bitker, Laurent

Subjects
respiratory system, therapeutics, circulatory and respiratory physiology, respiratory tract diseases
Abstract

Additional file 6: Multivariate analysis of variables associated with PEEP-induced lung recruitment

Published
2022
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25. High-flow nasal oxygen alone or alternating with non-invasive ventilation in critically ill immunocompromised patients with acute respiratory failure: a randomised controlled trial

Author

Rémi Coudroy, Jean-Pierre Frat, Stephan Ehrmann, Frédéric Pène, Maxens Decavèle, Nicolas Terzi, Gwenaël Prat, Charlotte Garret, Damien Contou, Arnaud Gacouin, Jeremy Bourenne, Christophe Girault, Christophe Vinsonneau, Jean Dellamonica, Guylaine Labro, Sébastien Jochmans, Alexandre Herbland, Jean-Pierre Quenot, Jérôme Devaquet, Dalila Benzekri, Emmanuel Vivier, Saad Nseir, Gwenhaël Colin, Didier Thevenin, Giacomo Grasselli, David Bougon, Mona Assefi, Claude Guérin, Thierry Lherm, Achille Kouatchet, Stephanie Ragot, Arnaud W Thille, Chatellier Delphine, Veinstein Anne, Boissier Florence, Reynaud Faustine, Rodriguez Maeva, Joly Florent, Arrivé François, De Roubin Victor, Robert René, Bodet-Contentin Laetitia, Salmon Gandonnière Charlotte, Mercier Emmanuelle, Jaubert Paul, Marin Nathalie, Paul Marine, Faure Morgane, Demiri Suela, Demoule Alexandre, Candille Clara, Dartevel Anaïs, Sigaud Florian, Jean Michel Vanessa, Le Mao Raphaël, Bailly Pierre, Seguin Amélie, Lascarrou Jean-Baptiste, Canet Emmanuel, Plantefève Gaëtan, Cally Radj, Tirolien Joanna, Maamar Adel, Painvin Benoit, Carvelli Julien, Gainnier Marc, Béduneau Gaëtan, Carpentier Dorothée, Malacrino Dominique, Marzouk Mehdi, Saccheri Clément, Mahr Nicolas, Soulier Pauline, Levrat Quentin, Andreu Pascal, Cortier David, and Nay Mai Anh

Subjects
Pulmonary and Respiratory Medicine, Adult, Oxygen, Immunocompromised Host, Respiratory Distress Syndrome, Noninvasive Ventilation, Critical Illness, Oxygen Inhalation Therapy, Settore MED/41 - Anestesiologia, Humans, Respiratory Insufficiency
Abstract

Although non-invasive ventilation (NIV) is recommended for immunocompromised patients with acute respiratory failure in the intensive care unit (ICU), it might have deleterious effects in the most severe patients. High-flow nasal oxygen (HFNO) alone might be an alternative method to reduce mortality. We aimed to determine whether HFNO alone could reduce the rate of mortality at day 28 compared with HFNO alternated with NIV.FLORALI-IM is a multicentre, open-label, randomised clinical trial conducted in 29 ICUs (28 in France and one in Italy). Adult immunocompromised patients with acute respiratory failure, defined as respiratory rate of 25 breaths per min or more and a partial pressure of arterial oxygen to inspired fraction of oxygen ratio of 300 mm Hg or lower, were randomly assigned (1:1) to HFNO alone (HFNO alone group) or NIV alternating with HFNO (NIV group). Key exclusion criteria were severe hypercapnia above 50 mm Hg, patients who could strongly benefit from NIV (ie, those with underlying chronic lung disease, with cardiogenic pulmonary oedema, or who were postoperative), severe shock, impaired consciousness defined as Glasgow coma score ≤12, urgent need for intubation, do not intubate order, and contraindication to NIV. Patients were assigned using computer-generated permuted blocks and were stratified according to centre and to the type of immunosuppression using a centralised web-based management system. In the HFNO alone group, patients were continuously treated by HFNO with a gas flow rate of 60 L/min or the highest tolerated. In the NIV group, patients were treated with NIV with a first session of at least 4 h, and then by sessions for a minimal duration of 12 h a day, with a dedicated ventilator, targeting a tidal volume below 8 mL/kg of predicted bodyweight, and with a positive end-expiratory level of at least 8 cm HBetween Jan 21, 2017 to March 4, 2019, of 497 eligible patients, 300 were randomly assigned but one patient withdrew consent, leaving 299 patients included in the intention-to-treat analysis (154 assigned to the HFNO alone group and 145 assigned to NIV group). Mortality rate at day 28 was 36% (95% CI 29·2 to 44·2; 56 of 154 patients) in the HFNO alone group and 35% (27·9 to 43·2; 51 of 145 patients) in the NIV group (absolute difference 1·2% [95% CI -9·6 to 11·9]; p=0·83). None of the other prespecified secondary outcomes were different between groups except for greater decreased discomfort after initiation of HFNO than with NIV (-4 mm on visual analogic scale [IQR -18 to 4] vs 0 mm [-16 to 17]; p=0·040).In critically ill immunocompromised patients with acute respiratory failure, the mortality rate did not differ between HFNO alone and NIV alternating with HFNO. However, study power was limited, so results should be interpreted with caution.French Ministry of Health.

Published
2021

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

Author

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

Published
2021
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28. Additional file 11 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Subjects
ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Data_FILES
Abstract

Additional file 11. Funding document.

Published
2021
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29. Additional file 4 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Abstract

Additional file 4. Study sites.

Published
2021
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30. Additional file 3 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Abstract

Additional file 3. WHO Trial Registration Dataset.

Published
2021
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31. Additional file 8 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Abstract

Additional file 8. IES-R questionnaire (French version).

Published
2021
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32. Additional file 7 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Abstract

Additional file 7. TMoCA questionnaire (French version).

Published
2021
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33. Additional file 2 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Subjects
Data_FILES
Abstract

Additional file 2. Study protocol version 4.

Published
2021
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34. Additional file 6 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Abstract

Additional file 6. Case report form.

Published
2021
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35. Additional file 5 of Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial

Author

Richard, Jean-Christophe, Yonis, Hodane, Bitker, Laurent, Roche, Sylvain, Wallet, Florent, Dupuis, Claire, Serrier, Hassan, Argaud, Laurent, Thiery, Guillaume, Delannoy, Bertrand, Pommier, Christian, Abraham, Paul, Muller, Michel, Aubrun, Frederic, Sigaud, Florian, Rigault, Guillaume, Joffredo, Emilie, Mezidi, Mehdi, Terzi, Nicolas, and Rabilloud, Muriel

Subjects
Data_FILES
Abstract

Additional file 5. Protocol summarized version.

Published
2021
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37. Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial.

Author

Sonneville R, Couffignal C, Sigaud F, Godard V, Audibert J, Contou D, Celier A, Djibre M, Schmidt J, Jaquet P, Mekontso Dessap A, Bourel C, Bellot R, Roy C, Lamara F, Essardy F, Timsit JF, Cornic R, and Bouadma L

Subjects
Adult, Humans, Intensive Care Units, Critical Care methods, Respiration, Artificial, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Propofol therapeutic use, Antipsychotic Agents therapeutic use, Delirium prevention & control
Abstract

Introduction: Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation., Methods and Analysis: The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation., Ethics and Dissemination: The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III-PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences., Trial Registration Number: NCT04273360., Competing Interests: Competing interests: RS received grants from the French Ministry of Health and from LB., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2024
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