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1. Risk factors for poor outcome in older patients admitted in a surgical intensive care unit.

Author

Occhiali E, Prolange P, Cassiau F, Roca F, Veber B, and Clavier T

Subjects
Humans, Male, Aged, Female, Prospective Studies, Risk Factors, Critical Care, Length of Stay, Activities of Daily Living, Intensive Care Units
Abstract

Background: The benefit of a stay in an intensive care unit (ICU) is not certain for older patients, particularly in the surgical context., Aims: The objective of this study was to identify the factors associated with an unfavourable outcome in this population., Design: Prospective, descriptive, monocentric study conducted in the surgical ICU of a French university hospital., Methods: Patients aged ≥75 years admitted in the surgical ICU for a predicted length of stay ≥48 hours were included. Patients received an initial and a 6-months nutritional and functional assessment performed by physicians and nurses. The outcome was considered as favourable if the Katz Activities of Daily Living (ADL) variation (ADL delta = 6-months ADL - ICU admission ADL) was between 0 and -0.5 point 6 months after ICU discharge and unfavourable if the ADL delta decreased by more than 0.5 points or if the patient had died 6 months after ICU discharge., Results: Fifty-six patients-32 (57%) male-aged 79 [77; 83] y were included. ICU mortality was 19%; 6-month mortality was 22%. Median ADL delta was -0.5 [-0.5-0] points. A low ADL score (P = .0438) and a low albumin level (P = .0213) at admission were the two independent factors associated with an unfavourable outcome., Conclusion: Mortality and loss of independence were high in this elderly population during and after their surgical ICU stay. The benefit of a systematic collaboration between intensive care specialists, ICU nurses, and geriatricians, to assess and manage nutritional and functional problems and to prevent a pejorative outcome in patients over 75 years old admitted in surgical ICU needs to be studied., Relevance to Clinical Practice: There should be systematic screening for objective markers of undernutrition and frailty on ICU admission of older patients as they are associated with a poor prognosis., (© 2021 British Association of Critical Care Nurses.)

Published
2023
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4. A Protocol to Set Up Needle-Free Connector with Positive Displacement on Central Venous Catheter in Intensive Care Unit.

Author

Clavier T, Franchina S, Lefevre-Scelles A, Gouin P, Besnier E, and Veber B

Subjects
2-Propanol therapeutic use, Catheter-Related Infections prevention & control, Catheters, Indwelling, Central Venous Catheters, Disinfection methods, Disinfection standards, Humans, Catheterization, Central Venous instrumentation, Catheterization, Central Venous methods, Intensive Care Units
Abstract

Needle-free connectors were initially designed and promoted to avoid blood exposure for healthcare workers. Some recent data suggest that the latest generation of connectors (with positive displacement) may be of interest for reducing central venous line infections. We have been using needle-free connectors for several years in our intensive care unit and here we present a protocol for installing these connectors on central venous catheters. After insertion of the catheter and control of the permeability of the lines, the connectors must be purged with 0.9% NaCl before being connected. The connectors replace all disposable caps used on infusion stopcocks and manifolds. All the connectors are changed every 7 days as recommended by the manufacturer (except when there is macroscopic contamination, which requires an immediate change of the connector). Before each injection, the connector must be disinfected for at least 3 seconds with 70% isopropyl alcohol. The connectors must not be disconnected (unless changed), as the injection is done through the device. Setting up the connectors slightly increases the total time required to place the catheter and there is no formal evidence that these connectors reduce the incidence of infectious or thrombotic complications. However, these devices simplify the management of central venous lines and prevent the catheter circuit from "opening" once it has been sterilely installed.

Published
2019
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5. Impact of MaxZero™ needle-free connector on the incidence of central venous catheter-related infections in surgical intensive care unit.

Author

Clavier T, Ferguen M, Gouin P, Gillibert A, Dusenne M, Merle V, and Veber B

Subjects
Catheter-Related Infections prevention & control, Equipment Design, Female, Humans, Incidence, Male, Middle Aged, Catheter-Related Infections epidemiology, Catheterization, Central Venous instrumentation, Intensive Care Units
Abstract

Background: Central venous catheter-related infections (CRIs) are a complication of central venous catheters in intensive care unit (ICU). Some needle-free connectors have been designed to decrease CRI, but there is a lack of data concerning their impact on infection., Objectives: The objective was to explore the impact of MaxZero™ connectors (BD; Franklin Lakes, US) on CRI in ICU., Methods: Observational, pre-post design study (2011-2013 and 2014-2016) conducted in the surgical ICU of a tertiary care hospital (18 beds). Patients with a central venous catheter and a length of stay ≥48 h were included. The connectors replaced all disposable caps used on infusion stopcocks and ramps. The primary parameter was to compare the incidence of CRI between the "before" period and the "after" period., Results: A total of 1633 patients were included (789 "before" and 844 "after"). There was no difference between groups concerning the global duration of catheterisation (12.5 ± 11.5 days vs. 12.1 ± 10.9 days). There were 61 CRIs before and 28 CRIs after the introduction of connectors; the incidence of CRI in the "before" group was 20.33 CRI/year (6.18 CRI per 1000 catheter-days) vs. 9.33 CRI/year (2.73 CRI per 1000 catheter-days) in the "after" group (incidence rate ratio = 0.44; 95% confidence interval = 0.28-0.68, p < 0.001). However, after a global analysis of the 6-year period, when adjusting for seasonal effect and pre-existing linear trend, the effect was no longer significant (adjusted incidence rate ratio = 0.57; 95% confidence interval = 0.24-1.35, p = 0.20)., Conclusions: Our results do not allow us to conclude to a potential beneficial effect of MaxZero™ on CRI but are compatible with its prolonged and safe use in ICU. Only future prospective works will be able to confirm the value of these connectors for CRI prevention., (Copyright © 2018 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.)

Published
2019
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6. Strategies of initiation and streamlining of antibiotic therapy in 41 French intensive care units.

Author

Montravers P, Dupont H, Gauzit R, Veber B, Bedos JP, and Lepape A

Subjects
Adult, After-Hours Care, Aged, Bacteremia mortality, Clinical Protocols, Critical Care statistics & numerical data, Drug Administration Schedule, Female, France epidemiology, Hospital Mortality, Humans, Intraabdominal Infections mortality, Male, Middle Aged, Pneumonia mortality, Prospective Studies, Risk Factors, Anti-Bacterial Agents therapeutic use, Bacteremia drug therapy, Critical Care methods, Intensive Care Units statistics & numerical data, Intraabdominal Infections drug therapy, Pneumonia drug therapy, Practice Patterns, Physicians' statistics & numerical data
Abstract

Introduction: Few studies have addressed the decision-making process of antibiotic therapy (AT) in intensive care unit (ICU) patients., Methods: In a prospective observational study, all consecutive patients admitted over a one-month period (2004) to 41 French surgical (n = 22) or medical/medico-surgical ICUs (n = 19) in 29 teaching university and 12 non-teaching hospitals were screened daily for AT until ICU discharge. We assessed the modalities of initiating AT, reasons for changes and factors associated with in ICU mortality including a specific analysis of a new AT administered on suspicion of a new infection., Results: A total of 1,043 patients (61% of the cohort) received antibiotics during their ICU stay. Thirty percent (509) of them received new AT mostly for suspected diagnosis of pneumonia (47%), bacteremia (24%), or intra-abdominal (21%) infections. New AT was prescribed on day shifts (45%) and out-of-hours (55%), mainly by a single senior physician (78%) or by a team decision (17%). This new AT was mainly started at the time of suspicion of infection (71%) and on the results of Gram-stained direct examination (21%). Susceptibility testing was performed in 261 (51%) patients with a new AT. This new AT was judged inappropriate in 58 of these 261 (22%) patients. In ICUs with written protocols for empiric AT (n = 25), new AT prescribed before the availability of culture results (P = 0.003) and out-of-hours (P = 0.04) was more frequently observed than in ICUs without protocols but the appropriateness of AT was not different. In multivariate analysis, the predictive factors of mortality for patients with new AT were absence of protocols for empiric AT (adjusted odds ratio (OR) = 1.64, 95% confidence interval (95%CI): 1.01 to 2.69), age ≥60 (OR = 1.97, 95% CI: 1.19 to 3.26), SAPS II score >38 (OR = 2.78, 95% CI: 1.60 to 4.84), rapidly fatal underlying diseases (OR = 2.91, 95% CI: 1.52 to 5.56), SOFA score ≥6 (OR = 4.48, 95% CI: 2.46 to 8.18)., Conclusions: More than 60% of patients received AT during their ICU stay. Half of them received new AT, frequently initiated out-of-hours. In ICUs with written protocols, empiric AT was initiated more rapidly at the time of suspicion of infection and out-of-hours. These results encourage the establishment of local recommendations for empiric AT.

Published
2011
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7. Reducing diarrhoea in an adult surgical intensive care unit: A quality improvement study.

Author

Occhiali, Emilie, Rodrigues, Bastien, Prieur, Wendy, Tiarci, Safia, Carmon, Nicolas, Veber, Benoit, and Achamrah, Najate

Subjects
DIARRHEA prevention, INTENSIVE care units, LENGTH of stay in hospitals, STATISTICAL significance, DIARRHEA, CAREGIVERS, NURSING, CRITICALLY ill, PATIENTS, HEALTH outcome assessment, FISHER exact test, MANN Whitney U Test, PRE-tests & post-tests, SURVEYS, CRITICAL care nurses, MEDICAL protocols, QUALITY assurance, CRITICAL care medicine, DESCRIPTIVE statistics, DATA analysis software, DISEASE management
Abstract

Background: Although diarrhoea is a real source of morbidity for critically ill patients, this issue has been little studied, making it difficult to understand its mechanisms and management. Aims: We conducted a quality improvement study in an adult surgical intensive care unit before/after the implementation of a specific protocol to firstly improve diarrhoea management for patient benefit and secondly to understand the impact on caregivers. Study design: The first part of this before/after study consisted in assessing the proportion of patients receiving an anti‐diarrheal treatment before (phase I)/after (phase II) the implementation of the protocol. The second part of the study was to survey the caregivers on this topic. Results: Sixty four adults were included (33 in phase I; 31 in phase II) with 280 diarrheal episodes (129 in phase I; 151 in phase II). The proportion of patients who received at least one anti‐diarrheal treatment was similar between the two phases (79% (26/33) vs. 68% (21/31), p =.40). Diarrhoea incidence was also similar (9% (33 patients/368 admissions) vs. 11% (31 patients/275 admissions), p =.35). The delay to initiate at least one treatment was significantly shorter in phase II (2 days [1–7] vs. 0 day [0–2]; p <.001). The patients' rehabilitation was no longer impacted by the occurrence of a diarrheal episode in phase II (39% (13/33) vs. 0% (0/31), p <.001). Eighty team members completed the surveys in phase I and 70 in phase II. Caregivers perceived diarrhoea like a burden and its economic impact remained high. Conclusions: The implementation of a protocol for the management of ICU diarrhoea did not increase the proportion of patients treated, but it did significantly improve the delay to initiate a treatment. The patients' rehabilitation was no longer affected by diarrhoea. Relevance to clinical practice: The use of specific anti‐diarrhoea guidelines may help to reduce the burden of diarrhoea in an ICU. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Benefits and risks of noninvasive oxygenation strategy in COVID-19: a multicenter, prospective cohort study (COVID-ICU) in 137 hospitals

Author

Schmidt, Matthieu, Demoule, Alexandre, Hajage, David, Pham, Tài, Combes, Alain, Dres, Martin, Lebbah, Said, Kimmoun, Antoine, Mercat, Alain, Beduneau, Gaëtan, Palmyre, Jessica, Prevost, Margot, Ricard, Jean-Damien, Ferré, Alexis, Fayolle, Pierre-Marie, Girault, Christophe, Pradel, Gael, Asfar, Pierre, Beloncle, François, Demiselle, Julien, Pavot, Arthur, Monnet, Xavier, Richard, Christian, Mayaux, Julien, Beurton, Alexandra, Daubin, Cédric, Descamps, Richard, Joret, Aurélie, Du Cheyron, Damien, Pene, Frédéric, Chiche, Jean-Daniel, Jozwiak, Mathieu, Jaubert, Paul, Voiriot, Guillaume, Fartoukh, Muriel, Teulier, Marion, Blayau, Clarisse, L’her, Erwen, Aubron, Cécile, Bodenes, Laetitia, Ferriere, Nicolas, Auchabie, Johann, Le Meur, Anthony, Pignal, Sylvain, Mazzoni, Thierry, Quenot, Jean-Pierre, Andreu, Pascal, Roudau, Jean-Baptiste, Labruyère, Marie, Nseir, Saad, Preau, Sébastien, Poissy, Julien, Mathieu, Daniel, Benhamida, Sarah, Paulet, Rémi, Roucaud, Nicolas, Thyrault, Martial, Daviet, Florence, Hraiech, Sami, Parzy, Gabriel, Sylvestre, Aude, Jochmans, Sébastien, Bouilland, Anne-Laure, Monchi, Mehran, Des Déserts, Marc Danguy, Mathais, Quentin, Rager, Gwendoline, Pasquier, Pierre, Jean, Reignier, Amélie, Seguin, Charlotte, Garret, Emmanuel, Canet, Dellamonica, Jean, Saccheri, Clément, Lombardi, Romain, Kouchit, Yanis, Jacquier, Sophie, Mathonnet, Armelle, Nay, Mai-Ahn, Runge, Isabelle, Martino, Frédéric, Flurin, Laure, Rolle, Amélie, Carles, Michel, Coudroy, Rémi, Thille, Arnaud, Frat, Jean-Pierre, Rodriguez, Maeva, Beuret, Pascal, Tientcheu, Audrey, Vincent, Arthur, Michelin, Florian, Tamion, Fabienne, Carpentier, Dorothée, Boyer, Déborah, Gissot, Valérie, Ehrmann, Stéphan, Gandonniere, Charlotte Salmon, Elaroussi, Djlali, Delbove, Agathe, Fedun, Yannick, Huntzinger, Julien, Lebas, Eddy, Kisoka, Grâce, Grégoire, Céline, Marchetta, Stella, Lambermont, Bernard, Argaud, Laurent, Baudry, Thomas, Bertrand, Pierre-Jean, Dargent, Auguste, Guitton, Christophe, Chudeau, Nicolas, Landais, Mickaël, Darreau, Cédric, Ferre, Alexis, Gros, Antoine, Lacave, Guillaume, Bruneel, Fabrice, Neuville, Mathilde, Devaquet, Jérôme, Tachon, Guillaume, Gallot, Richard, Chelha, Riad, Galbois, Arnaud, Jallot, Anne, Lemoine, Ludivine Chalumeau, Kuteifan, Khaldoun, Pointurier, Valentin, Jandeaux, Louise-Marie, Mootien, Joy, Damoisel, Charles, Sztrymf, Benjamin, Chommeloux, Juliette, Luyt, Charles Edouard, Schortgen, Frédérique, Rusel, Leon, Jung, Camille, Gobert, Florent, Vimpere, Damien, Lamhaut, Lionel, Sauneuf, Bertrand, Charrrier, Liliane, Calus, Julien, Desmeules, Isabelle, Painvin, Benoît, Tadie, Jean-Marc, Castelain, Vincent, Michard, Baptiste, Herbrecht, Jean-Etienne, Baldacini, Mathieu, Weiss, Nicolas, Demeret, Sophie, Marois, Clémence, Rohaut, Benjamin, Moury, Pierre-Henri, Savida, Anne-Charlotte, Couadau, Emmanuel, Série, Mathieu, Alexandru, Nica, Bruel, Cédric, Fontaine, Candice, Garrigou, Sonia, Mahler, Juliette Courtiade, Leclerc, Maxime, Ramakers, Michel, Garçon, Pierre, Massou, Nicole, van Vong, Ly, Sen, Juliane, Lucas, Nolwenn, Chemouni, Franck, Stoclin, Annabelle, Avenel, Alexandre, Faure, Henri, Gentilhomme, Angélie, Ricome, Sylvie, Abraham, Paul, Monard, Céline, Textoris, Julien, Rimmele, Thomas, Montini, Florent, Lejour, Gabriel, Lazard, Thierry, Etienney, Isabelle, Kerroumi, Younes, Dupuis, Claire, Bereiziat, Marine, Coupez, Elisabeth, Thouy, François, Hoffmann, Clément, Donat, Nicolas, Chrisment, Anne, Blot, Rose-Marie, Jacquot, Audrey, Mattei, Matthieu, Levy, Bruno, Ravan, Ramin, Dopeux, Loïc, Liteaudon, Jean-Mathias, Roux, Delphine, Rey, Brice, Anghel, Radu, Schenesse, Deborah, Gevrey, Vincent, Castanera, Jermy, Petua, Philippe, Madeux, Benjamin, Hartman, Otto, Piagnerelli, Michael, Joosten, Anne, Noel, Cinderella, Biston, Patrick, Noel, Thibaut, Bouar, Gurvan, Boukhanza, Messabi, Demarest, Elsa, Bajolet, Marie-France, Charrier, Nathanaël, Quenet, Audrey, Zylberfajn, Cécile, Dufour, Nicolas, Mégarbane, Buno, Voicu, Sqébastian, Deye, Nicolas, Malissin, Isabelle, Legay, François, Debarre, Matthieu, Barbarot, Nicolas, Fillatre, Pierre, Delord, Bertrand, Laterrade, Thomas, Saghi, Tahar, Pujol, Wilfried, Cungi, Pierre Julien, Esnault, Pierre, Cardinale, Mickael, Ha, Vivien Hong Tuan, Fleury, Grégory, Brou, Marie-Ange, Zafimahazo, Daniel, Tran-Van, David, Avargues, Patrick, Carenco, Lisa, Robin, Nicolas, Ouali, Alexandre, Houdou, Lucie, Le Terrier, Christophe, Suh, Noémie, Primmaz, Steve, Pugin, Jérome, Weiss, Emmanuel, Gauss, Tobias, Moyer, Jean-Denis, Burtz, Catherine Paugam, La Combe, Béatrice, Smonig, Rolland, Violleau, Jade, Cailliez, Pauline, Chelly, Jonathan, Marchalot, Antoine, Saladin, Cécile, Bigot, Christelle, Fatséas, Jules, Ibrahim, Amr, Resiere, Dabor, Hage, Rabih, Cholet, Clémentine, Cantier, Marie, Trouiler, Pierre, Montravers, Philippe, Lortat-Jacob, Brice, Tanaka, Sebastien, Dinh, Alexy Tran, Duranteau, Jacques, Harrois, Anatole, Dubreuil, Guillaume, Werner, Marie, Godier, Anne, Hamada, Sophie, Zlotnik, Diane, Nougue, Hélène, Mekontso-Dessap, Armand, Carteaux, Guillaume, Razazi, Keyvan, de Prost, Nicolas, Mongardon, Nicolas, Langeron, Olivier, Levesque, Eric, Attias, Arié, de Roquetaillade, Charles, Chousterman, Benjamin, Mebazaa, Alexandre, Gayat, Etienne, Garnier, Marc, Pardo, Emmanuel, Satre-Buisson, Lea, Gutton, Christophe, Yvin, Elise, Marcault, Clémence, Azoulay, Elie, Darmon, Michael, Oufella, Hafid Ait, Hariri, Geoffroy, Urbina, Tomas, Mazerand, Sandie, Heming, Nicholas, Santi, Francesca, Moine, Pierre, Annane, Djillali, Bouglé, Adrien, Omar, Edris, Lancelot, Aymeric, Begot, Emmanuelle, Plantefeve, Gaétan, Contou, Damien, Mentec, Hervé, Pajot, Olivier, Faguer, Stanislas, Cointault, Olivier, Lavayssiere, Laurence, Nogier, Marie-Béatrice, Jamme, Matthieu, Pichereau, Claire, Hayon, Jan, Outin, Hervé, Dépret, François, Coutrot, Maxime, Chaussard, Maité, Guillemet, Lucie, Goffin, Pierre, Thouny, Romain, Guntz, Julien, Jadot, Laurent, Persichini, Romain, Jean-Michel, Vanessa, Georges, Hugues, Caulier, Thomas, Pradel, Gaël, Hausermann, Marie-Hélène, Nguyen-Valat, Thi My Hue, Boudinaud, Michel, Vivier, Emmanuel, Rosseli, Sylvène, Bourdin, Gaël, Pommier, Christian, Vinclair, Marc, Poignant, Simon, Mons, Sandrine, Bougouin, Wulfran, Bruna, Franklin, Maestraggi, Quentin, Roth, Christian, Bitker, Laurent, Dhelft, François, Bonnet-Chateau, Justine, Filippelli, Mathilde, Morichau-Beauchant, Tristan, Thierry, Stéphane, Le Roy, Charlotte, Jouan, Mélanie Saint, Goncalves, Bruno, Mazeraud, Aurélien, Daniel, Matthieu, Sharshar, Tarek, Cadoz, Cyril, Gaci, Rostane, Gette, Sébastien, Louis, Guillaune, Sacleux, Sophe-Caroline, Ordan, Marie-Amélie, Cravoisy, Aurélie, Conrad, Marie, Courte, Guilhem, Gibot, Sébastien, Benzidi, Younès, Casella, Claudia, Serpin, Laurent, Setti, Jean-Lou, Besse, Marie-Catherine, Bourreau, Anna, Pillot, Jérôme, Rivera, Caroline, Vinclair, Camille, Robaux, Marie-Aline, Achino, Chloé, Delignette, Marie-Charlotte, Mazard, Tessa, Aubrun, Frédéric, Bouchet, Bruno, Frérou, Aurélien, Muller, Laura, Quentin, Charlotte, Degoul, Samuel, Stihle, Xavier, Sumian, Claude, Bergero, Nicoletta, Lanaspre, Bernard, Quintard, Hervé, Maiziere, Eve Marie, Egreteau, Pierre-Yves, Leloup, Guillaume, Berteau, Florin, Cottrel, Marjolaine, Bouteloup, Marie, Jeannot, Matthieu, Blanc, Quentin, Saison, Julien, Geneau, Isabelle, Grenot, Romaric, Ouchike, Abdel, Hazera, Pascal, Masse, Anne-Lyse, Demiri, Suela, Vezinet, Corinne, Baron, Elodie, Benchetrit, Deborah, Monsel, Antoine, Trebbia, Grégoire, Schaack, Emmanuelle, Lepecq, Raphaël, Bobet, Mathieu, Vinsonneau, Christophe, Dekeyser, Thibault, Delforge, Quentin, Rahmani, Imen, Vivet, Bérengère, Paillot, Jonathan, Hierle, Lucie, Chaignat, Claire, Valette, Sarah, Her, Benoït, Brunet, Jennifier, Page, Mathieu, Boiste, Fabienne, Collin, Anthony, Bavozet, Florent, Garin, Aude, Dlala, Mohamed, Mhamdi, Kais, Beilouny, Bassem, Lavalard, Alexandra, Perez, Severine, Veber, Benoit, Guitard, Pierre-Gildas, Gouin, Philippe, Lamacz, Anna, Plouvier, Fabienne, Delaborde, Bertrand, Kherchache, Aïssa, Chaalal, Amina, Amouretti, Marc, Freita-Ramos, Santiago, Roux, Damien, Constantin, Jean-Michel, Assefi, Mona, Lecore, Marine, Selves, Agathe, Prevost, Florian, Lamer, Christian, Shi, Ruiying, Knani, Lyes, Floury, Sébastien Pili, Vettoretti, Lucie, Levy, Michael, Marsac, Lucile, Dauger, Stéphane, Guilmin-Crépon, Sophie, Winiszewski, Hadrien, Piton, Gael, Soumagne, Thibaud, Capellier, Gilles, Putegnat, Jean-Baptiste, Bayle, Frédérique, Perrou, Maya, Thao, Ghyslaine, Géri, Guillaume, Charron, Cyril, Repessé, Xavier, Vieillard-Baron, Antoine, Guilbart, Mathieu, Roger, Pierre-Alexandre, Hinard, Sébastien, Macq, Pierre-Yves, Chaulier, Kevin, Goutte, Sylvie, Chillet, Patrick, Pitta, Anaïs, Darjent, Barbara, Bruneau, Amandine, Lasocki, Sigismond, Leger, Maxime, Gergaud, Soizic, Lemarie, Pierre, Terzi, Nicolas, Schwebel, Carole, Dartevel, Anaïs, Galerneau, Louis-Marie, Diehl, Jean-Luc, Hauw-Berlemont, Caroline, Péron, Nicolas, Guérot, Emmanuel, Amoli, Abolfazl Mohebbi, Benhamou, Michel, Deyme, Jean-Pierre, Andremont, Olivier, Lena, Diane, Cady, Julien, Causeret, Arnaud, de la Chapelle, Arnaud, Cracco, Christophe, Rouleau, Stéphane, Schnell, David, Foucault, Camille, Lory, Cécile, Chapelle, Thibault, Bruckert, Vincent, Garcia, Julie, Sahraoui, Abdlazize, Abbosh, Nathalie, Bornstain, Caroline, Pernet, Pierre, Poirson, Florent, Pasem, Ahmed, Karoubi, Philippe, Poupinel, Virginie, Gauthier, Caroline, Bouniol, François, Feuchere, Philippe, Heron, Anne, Carreira, Serge, Emery, Malo, Le Floch, Anne Sophie, Giovannangeli, Luana, Herzog, Nicolas, Giacardi, Christophe, Baudic, Thibaut, Thill, Chloé, Tubach, Florence, Bonnet, Nicolas, Ebstein, Nathan, Gaudry, Stéphane, Cohen, Yves, Noublanche, Julie, Lesieur, Olivier, Sément, Arnaud, Roca-Cerezo, Isabel, Pascal, Michel, Sma, Nesrine, Colin, Gwenhaël, Lacherade, Jean-Claude, Bionz, Gauthier, Maquigneau, Natacha, Bouzat, Pierre, Durand, Michel, Hérault, Marie-Christine, Payen, Jean-Francois, Service de Réanimation Médicale et Toxicologique [Hôpital Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Optimisation thérapeutique en Neuropsychopharmacologie (OPTeN (UMR_S_1144 / U1144)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), COVID-ICU group, for the REVA network, COVID-ICU investigators, and Mégarbane, Bruno

Subjects
Critical Care and Intensive Care Medicine, Acute respiratory failure, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Risk Assessment, Mechanical ventilation, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Humans, Prospective Studies, Mortality, Outcome, [SDV.MHEP.ME] Life Sciences [q-bio]/Human health and pathology/Emerging diseases, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Noninvasive Ventilation, Acute respiratory distress syndrome, RC86-88.9, Research, COVID-19, Medical emergencies. Critical care. Intensive care. First aid, Hospitals, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.TOX] Life Sciences [q-bio]/Toxicology, Intensive Care Units, [SDV.TOX]Life Sciences [q-bio]/Toxicology, High-flow nasal cannula, [SDV.MHEP.MI] Life Sciences [q-bio]/Human health and pathology/Infectious diseases, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Intubation
Abstract

Rational To evaluate the respective impact of standard oxygen, high-flow nasal cannula (HFNC) and noninvasive ventilation (NIV) on oxygenation failure rate and mortality in COVID-19 patients admitted to intensive care units (ICUs). Methods Multicenter, prospective cohort study (COVID-ICU) in 137 hospitals in France, Belgium, and Switzerland. Demographic, clinical, respiratory support, oxygenation failure, and survival data were collected. Oxygenation failure was defined as either intubation or death in the ICU without intubation. Variables independently associated with oxygenation failure and Day-90 mortality were assessed using multivariate logistic regression. Results From February 25 to May 4, 2020, 4754 patients were admitted in ICU. Of these, 1491 patients were not intubated on the day of ICU admission and received standard oxygen therapy (51%), HFNC (38%), or NIV (11%) (P P P = 0.013) but not NIV (OR 1.57, 95% CI 0.78–3.21) was associated with a reduction in oxygenation failure). Overall 90-day mortality was 21%. By multivariable analysis, HFNC was not associated with a change in mortality (OR 0.90, 95% CI 0.61–1.33), while NIV was associated with increased mortality (OR 2.75, 95% CI 1.79–4.21, P Conclusion In patients with COVID-19, HFNC was associated with a reduction in oxygenation failure without improvement in 90-day mortality, whereas NIV was associated with a higher mortality in these patients. Randomized controlled trials are needed.

Published
2021

10. Anticoagulation Monitoring with Activated Partial ThromboPlastin Time and Anti-Xa Activity in Intensive Care Unit Patients: Interest of Thrombin Generation Assay.

Author

Billoir, Paul, Elie, Thomas, Levy, Jerrold H., Besnier, Emmanuel, Dureuil, Bertrand, Veber, Benoit, Le Cam-Duchez, Véronique, and Clavier, Thomas

Subjects
THROMBIN, PARTIAL thromboplastin time, INTENSIVE care patients, BLOOD coagulation factors, INTENSIVE care units
Abstract

Current guidelines recommend monitoring the anticoagulant effect of unfractionated heparin (UFH) by measuring anti-Xa activity rather than activated partial thromboplastin time (aPTT) in intensive care unit (ICU) patients. The primary objective of this study was to evaluate the correlation of aPTT, anti-Xa activity, and thrombin generation in UFH-treated ICU patients. A prospective observational pilot study was conducted in adult surgical ICU patients treated with UFH. aPTT and anti-Xa activity were monitored daily. The therapeutic target was aPTT between 50 s and 84 s, and/or anti-Xa between 0.3 and 0.7 U/mL. Correlation among aPTT, anti-Xa activity, and thrombin generation was determined by measuring endogenous thrombin potential (ETP), with the inflammatory response evaluated. C-reactive protein (CRP) was used as a marker of inflammatory response. The plasma of 107 samples from 30 ICU patients was analyzed. The correlation between aPTT and anti-Xa activity was 0.66, CI95% [0.54;0.76] (p < 0.0001). Although thrombin generation, aPTT, and anti-Xa were correlated with inflammatory responses, the correlation was higher with thrombin generation and anti-Xa activity compared to aPTT. When aPTT was in a therapeutic range, a low thrombin generation was observed but was 50% inhibited when anti-Xa was in a therapeutic range. Coagulation testing with aPTT, anti-Xa correlated with thrombin generation. A 50% decrease in thrombin generation was observed when anti-Xa was within a therapeutic range. Further work is needed to evaluate coagulation biomarker responses and clinical outcomes in specific ICU populations. [ABSTRACT FROM AUTHOR]

Published
2022
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11. End-of-life care in the French ICU: Impact of Claeys-Leonetti law on decision to withhold or withdraw life-supportive therapy

Author

Le Dorze, Matthieu, Kandelman, Stanislas, Veber, Benoit, Hôpital Lariboisière, Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon, Service de soins intensifs [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Beaujon [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)

Subjects
Critical Care, Patients, Clinical Decision-Making, Critical Care and Intensive Care Medicine, [SDV.MP.PRO]Life Sciences [q-bio]/Microbiology and Parasitology/Protistology, Treatment Refusal, 03 medical and health sciences, 0302 clinical medicine, Humans, 030212 general & internal medicine, Physician's Role, Third-Party Consent, ComputingMilieux_MISCELLANEOUS, [SDV.MP.MYC]Life Sciences [q-bio]/Microbiology and Parasitology/Mycology, Terminal Care, Palliative Care, General Medicine, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Dissent and Disputes, Intensive Care Units, Anesthesiology and Pain Medicine, Withholding Treatment, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, France, Deep Sedation, Advance Directives, Medical Futility, 030217 neurology & neurosurgery
Abstract

International audience

Published
2019

12. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial

Author

Jean-Michel Constantin, Matthieu Jabaudon, Jean-Yves Lefrant, Samir Jaber, Jean-Pierre Quenot, Olivier Langeron, Martine Ferrandière, Fabien Grelon, Philippe Seguin, Carole Ichai, Benoit Veber, Bertrand Souweine, Thomas Uberti, Sigismond Lasocki, François Legay, Marc Leone, Nathanael Eisenmann, Claire Dahyot-Fizelier, Hervé Dupont, Karim Asehnoune, Achille Sossou, Gérald Chanques, Laurent Muller, Jean-Etienne Bazin, Antoine Monsel, Lucile Borao, Jean-Marc Garcier, Jean-Jacques Rouby, Bruno Pereira, Emmanuel Futier, Cayot Sophie, Godet Thomas, Guerin Renaud, Verlac Camille, Chabanne Russel, Cosserant Bernard, Blondonnet Raiko, Lautrette Alexandre, Eisenmann Nathanael, Muller Laurent, Massanet Pablo, Boutin Caroline, Barbar Saber, Roger Claire, Belafia Fouad, Cisse Moussa, Monnin Marion, Conseil Matthieu, Carr Julie, De Jong Audrey, Dargent Auguste, Andreu Pascal, Lebouvrier Thomas, Launey Yoann, Roquilly Antoine, Cinotti Raphael, Tellier Anne-Charlotte, Barbaz Mathilde, Cohen Benjamin, Lemarche Edouard, Bertrand Pierre-Marie, Arberlot Charlotte, Zieleskiewicz Laurent, Hammad Emmanuelle, Duclos Garry, Mathie Calypso, Dupont Herve, Veber Benoit, Orban Jean-Christophe, Quintard Hervé, Rimmele Thomas, Crozon-Clauzel Julien, Le Core Marinne, Grelon Fabien, Assefi Mona, Petitas Frank, Morel Jerome, Molliex Serge, Hadanou Nanadougmar, CHU Clermont-Ferrand, Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier Le Mans (CH Le Mans), CHU Pontchaillou [Rennes], Nutrition, Métabolismes et Cancer (NuMeCan), Institut National de la Recherche Agronomique (INRA)-Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de réanimation, Centre Hospitalier Universitaire de Nice (CHU Nice)-Hôpital St Roch, Département d'anesthésie-Réanimation-Samu, CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Unité de soins intensifs [Clermont Ferrand], CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Edouard Herriot Hospital, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), CHU de Saint-Brieuc, Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Université de Montpellier (UM), Immunologie - Immunopathologie - Immunothérapie (I3), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Unité de Biostatistiques [CHU Clermont-Ferrand], Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Institut Pascal (IP), SIGMA Clermont (SIGMA Clermont)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Génétique, Reproduction et Développement (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])-Centre National de la Recherche Scientifique (CNRS), Department of Perioperative Medicine, CHU Clermont-Ferrand, CHU Pitié-Salpêtrière [APHP], Hopital Général, Le Mans, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Clermont-Ferrand-Hôpital Gabriel Montpied, Hospital General Saint-Brieuc, Hôpital Nord [CHU - APHM]-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU), Centre Régional de Lutte Contre le Cancer Jean Perrin, Centre hospitalier universitaire d'Amiens (CHU Amiens-Picardie), Service de réanimation adulte, département d'anesthésie-réanimation, CHU Clermont-Ferrand-Hôtel Dieu, Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Pierre et Marie Curie - Paris 6 (UPMC), University Hospital of Clermont-Ferrand, Institut Pascal - Clermont Auvergne (IP), Sigma CLERMONT (Sigma CLERMONT)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), Unité de biostatistiques, CHU Clermont-Ferrand-Hôpital Montpied, Génétique, Reproduction et Développement - Clermont Auvergne (GReD ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA)-Centre National de la Recherche Scientifique (CNRS), MORNET, Dominique, Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
Pulmonary and Respiratory Medicine, Male, medicine.medical_specialty, ARDS, medicine.medical_treatment, [SDV]Life Sciences [q-bio], law.invention, Positive-Pressure Respiration, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Fraction of inspired oxygen, Intensive care, medicine, Prone Position, Tidal Volume, Humans, Single-Blind Method, 030212 general & internal medicine, Prospective Studies, Precision Medicine, Lung, Positive end-expiratory pressure, Tidal volume, ComputingMilieux_MISCELLANEOUS, Proportional Hazards Models, Mechanical ventilation, Respiratory Distress Syndrome, business.industry, Hazard ratio, Middle Aged, medicine.disease, Respiration, Artificial, 3. Good health, [SDV] Life Sciences [q-bio], Intensive Care Units, Editorial Commentary, Treatment Outcome, 030228 respiratory system, Female, France, business
Abstract

The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care.We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589.From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012.Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial.French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).

Published
2019

13. Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study.

Author

Marjanovic, Nicolas, Boisson, Matthieu, Asehnoune, Karim, Foucrier, Arnaud, Lasocki, Sigismond, Ichai, Carole, Leone, Marc, Pottecher, Julien, Lefrant, Jean-Yves, Falcon, Dominique, Veber, Benoit, Chabanne, Russell, Drevet, Claire-Marie, Pili-Floury, Sébastien, Dahyot-Fizelier, Claire, Kerforne, Thomas, Seguin, Sabrina, de Keizer, Joe, Frasca, Denis, and Guenezan, Jérémy

Subjects
ARTIFICIAL respiration, VENTILATOR-associated pneumonia, RANDOM number generators, INTENSIVE care units, PNEUMATIC machinery, ENDOTRACHEAL tubes
Abstract

Background: Ventilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination.Research Question: Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma?Study Design and Methods: In this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants.Results: A total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted.Interpretation: Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma.Clinical Trial Registration: ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

Published
2021
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14. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial.

Author

Constantin, Jean-Michel, Jabaudon, Matthieu, Lefrant, Jean-Yves, Jaber, Samir, Quenot, Jean-Pierre, Langeron, Olivier, Ferrandière, Martine, Grelon, Fabien, Seguin, Philippe, Ichai, Carole, Veber, Benoit, Souweine, Bertrand, Uberti, Thomas, Lasocki, Sigismond, Legay, François, Leone, Marc, Eisenmann, Nathanael, Dahyot-Fizelier, Claire, Dupont, Hervé, and Asehnoune, Karim

Subjects
ADULT respiratory distress syndrome, POSITIVE end-expiratory pressure, INTENSIVE care units, LUNGS
Abstract

The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care. We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov , NCT02149589. From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61–1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p<0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5–5·1; p=0·012. Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial. French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013). [ABSTRACT FROM AUTHOR]

Published
2019
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