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1. Thoracic epidural analgesia in intensive care unit patients with acute pancreatitis: the EPIPAN multicenter randomized controlled trial

Author

Matthieu Jabaudon, Alexandra Genevrier, Samir Jaber, Olivier Windisch, Stéphanie Bulyez, Pierre-François Laterre, Etienne Escudier, Achille Sossou, Philippe Guerci, Pierre-Marie Bertrand, Pierre-Eric Danin, Martin Bonnassieux, Leo Bühler, Claudia Paula Heidegger, Russell Chabanne, Thomas Godet, Laurence Roszyk, Vincent Sapin, Emmanuel Futier, Bruno Pereira, Jean-Michel Constantin, and for the EPIPAN study group

Subjects
Acute pancreatitis, Intensive care unit, Epidural analgesia, Ventilator-free days, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background Findings from preclinical studies and one pilot clinical trial suggest potential benefits of epidural analgesia in acute pancreatitis. We aimed to assess the efficacy of thoracic epidural analgesia, in addition to usual care, in improving clinical outcomes of intensive care unit patients with acute pancreatitis. Methods A multicenter, open-label, randomized, controlled trial including adult patients with a clinical diagnosis of acute pancreatitis upon admission to the intensive care unit. Participants were randomly assigned (1:1) to a strategy combining thoracic epidural analgesia and usual care (intervention group) or a strategy of usual care alone (control group). The primary outcome was the number of ventilator-free days from randomization until day 30. Results Between June 2014 and January 2019, 148 patients were enrolled, and 135 patients were included in the intention-to-treat analysis, with 65 patients randomly assigned to the intervention group and 70 to the control group. The number of ventilator-free days did not differ significantly between the intervention and control groups (median [interquartile range], 30 days [15–30] and 30 days [18–30], respectively; median absolute difference of − 0.0 days, 95% CI − 3.3 to 3.3; p = 0.59). Epidural analgesia was significantly associated with longer duration of invasive ventilation (median [interquartile range], 14 days [5–28] versus 6 days [2–13], p = 0.02). Conclusions In a population of intensive care unit adults with acute pancreatitis and low requirement for intubation, this first multicenter randomized trial did not show the hypothesized benefit of epidural analgesia in addition to usual care. Safety of epidural analgesia in this setting requires further investigation. Trial registration: ClinicalTrials.gov registration number NCT02126332 , April 30, 2014.

Published
2023
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2. Risk factors and events in the adult intensive care unit associated with pain as self-reported at the end of the intensive care unit stay

Author

Pierre Kalfon, Mohamed Boucekine, Philippe Estagnasie, Marie-Agnès Geantot, Audrey Berric, Georges Simon, Bernard Floccard, Thomas Signouret, Mélanie Fromentin, Martine Nyunga, Juliette Audibert, Adel Ben Salah, Bénédicte Mauchien, Achille Sossou, Marion Venot, René Robert, Arnaud Follin, Anne Renault, Maïté Garrouste-Orgeas, Olivier Collange, Quentin Levrat, Isabelle Villard, Didier Thevenin, Julien Pottecher, René-Gilles Patrigeon, Nathalie Revel, Coralie Vigne, Elie Azoulay, Olivier Mimoz, Pascal Auquier, Karine Baumstarck, and IPREA Study Group

Subjects
Critical care, Pain, Discomfort, IPREA, Chest drain, Intra-hospital transport, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract

Abstract Background The short-term and long-term consequences of the most frequent painful procedures performed in the ICU are unclear. This study aimed to identify the risk factors associated with pain-related discomfort perceived by critically ill patients during the whole ICU stay as self-reported by patients at the end of their ICU stay. Methods The study involved 34 ICUs. Adult patients who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Discomforts, including the pain-related discomfort, were assessed using the French 18-item questionnaire on discomfort in ICU patients, the “Inconforts des Patients de REAnimation” (IPREA). Patients scored each item from 0 (minimal discomfort) to 10 (maximal discomfort). Associations between patient characteristics at ICU admission, life support therapies and main potentially painful procedures performed during the ICU stay and pain-related discomfort scores assessed at the end of the ICU stay were analyzed. Results Patients with complete IPREA questionnaires (n = 2130) were included. The median pain-related discomfort score was 3 (IQR 0–5). From the univariate analysis, pain-related discomfort scores were negatively correlated with age and positively correlated with ICU stay duration; surgical patients reported significant higher pain-related discomfort scores than medical patients; chest drain insertion, chest drain removal, use of bladder catheter, central venous catheter (CVC) insertion, complex dressing change, and intra-hospital transport were associated with pain-related discomfort scores. From the multivariate analyses using generalized estimating equations models, only age, chest drain removal, use of a bladder catheter, CVC insertion, and intra-hospital transport were the main risk factors associated with pain-related discomfort scores. Conclusion Patients who underwent chest drain removal, bladder catheter, CVC insertion, and intra-hospital transport during their ICU stay reported higher pain-related discomfort scores (with respect to the whole ICU stay and assessed at the end of their ICU stay) than patients who did not experience these events. This study may pave the way for further targeted studies aiming at investigating a causal link between these common procedures in the ICU and adult critically ill patients’ perceptions of their ICU stay regarding recalled pain. Trial Registration: Clinicaltrials.gov Identifier NCT02442934, retrospectively registered on May 13, 2015

Published
2020
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3. Assessment of patients’ self-perceived intensive care unit discomforts: Validation of the 18-item version of the IPREA

Author

Karine Baumstarck, Mohamed Boucekine, Philippe Estagnasie, Marie-Agnès Geantot, Audrey Berric, Georges Simon, Bernard Floccard, Thomas Signouret, Mélanie Fromentin, Martine Nyunga, Achille Sossou, Marion Venot, René Robert, Arnaud Follin, Juliette Audibert, Anne Renault, Maïté Garrouste-Orgeas, Olivier Collange, Quentin Levrat, Isabelle Villard, Didier Thevenin, Julien Pottecher, René-Gilles Patrigeon, Nathalie Revel, Coralie Vigne, Elie Azoulay, Olivier Mimoz, Pascal Auquier, Pierre Kalfon, and the IPREA Study group

Subjects
IPREA, Discomfort, Critical care, Validation, Questionnaire, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

Abstract Background and aims We reported the validation of the 18-item version of the ‘Inconforts des Patients de REAnimation (IPREA)’ questionnaire that includes 2 new items exploring feeling depressed and shortness of breath during an intensive care unit (ICU) stay. Methods The validation process was integrated in a multicenter, cluster-randomized, controlled, two-parallel group study built to assess the effectiveness of a tailored multicomponent program for reducing self-perceived discomfort in the ICU. All patients aged 18 years or older who survived an ICU stay of 3 calendar days or more were eligible for inclusion. Data collection included demographics (sex, age), type of admission (medical and surgical), health status scores at admission (Knaus score and McCabe index, Simplified Acute Physiology Score (SAPS) II), specific ICU therapeutics such as mechanical ventilation (MV), noninvasive ventilation (NIV), use of vasopressors, or renal replacement therapy (RRT), and ICU stay duration. Results A total of 994 patients were included. The initial structure of IPREA was confirmed using confirmatory factor analysis showing satisfactory fit (RMSEA at 0.042, CFI at 0.912). No multidimensional structure was identified, allowing the calculation of an overall discomfort score. The three highest discomforts were sleep deprivation, thirst, and perfusion lines and other devices, and the 3 lowest discomforts were limited visiting hours, hunger, and isolation. The overall discomfort score of the 18-item version of IPREA did not differ between men and women. Higher age was significantly correlated with a lower overall discomfort score. While MV was not linked to self-reported discomfort, patients treated by NIV reported higher overall discomfort scores than patients not treated by NIV. Conclusion The 18-item version of IPREA is easy to use and possesses satisfactory psychometric properties. The availability of a reliable and valid French questionnaire asking about patients’ self-perceived ICU discomforts enables feedback from the health care team to be incorporated in a continuous quality health care improvement strategy. Trial registration clinicaltrial.gov NCT02442934 (registration date: May 18, 2015, retrospectively registered).

Published
2019
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4. Implementation of French recommendations for the prevention and the treatment of hospital-acquired pneumonia: a cluster-randomized trial

Author

Achille Sossou, Rémy Bellier, Kevin Lagarde, Alexandre Mansour, Jean-Michel Constantin, Marc Leone, Céline Monard, Brice Fermier, Cedric Carrie, Sigismond Lasocki, Armine Rouhani, Alexy Tran Dinh, Pierre-François Perrigault, Antoine Roquilly, Jerôme Morel, Ghilain Beauplet, Sami Blidi, Claire Dahyot-Fizelier, Christian Isetta, Marie-Anne Vibet, Mathilde Holleville, Philippe Guerci, Clément Gakuba, Fanny Feuillet, Karim Asehnoune, Jeremy Bourenne, Marc Danguy des Déserts, Benjamin G. Chousterman, Karim Lakhal, Alexandru Cupaciu, Arnaud Foucrier, Gerald Chanques, Calypso Mathieu, Adrien Oudotte, Véronique Sébille, Hugues De Courson, Pauline Cailliez, Jonathan Au Duong, Department of Anesthesiology and Critical Care, Hotel Dieu, CHU Nantes, Nantes, Laboratory EA3826, Faculty of Medicine, University of Nantes, Nantes, 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), Département Anesthésie Réanimation, CHU d'Angers, Université d'Angers, Angers, Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Beaujon (AP/HP), Beaujon, Intensive Care Unit, Simone Veil Hospital, Blois, Department of Neuro-Critical Care, Pellegrin Hospital, Bordeaux, Surgical and trauma Intensive Care, Pellegrin Hospital, Bordeaux, Department of Anesthesiology and Critical Care, Hospital Inter-Armée Clermont Tonnerre, Brest, Department of Anesthesiology and Critical Care, CHU Caen, Caen, Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Department of neuro-critical care, AP/HP, Creteil, Intensive Care Unit, Eaubonne Hospital, Eaubonne, Department of Anesthesiology and Critical Care, Emile Roux Hospital, Le Puy en Velay, Intensive Care Unit, Lorient Hospital, Lorient, Department of Anesthesiology and Critical Care, Hôpital Édouard Herriot, Hospices Civils de Lyon, Lyon, Department of Neuro-Critical Care, Hospices Civils de Lyon, Lyon, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Department of Anesthesiology and Critical Care Medicine, Hôpital Nord, Marseille, Aix-Marseille University, Assistance Publique Hôpitaux de Marseille, Emergency Intensive Care Unit, Hopital la Timone, Marseille, Department of Anesthesiology and Cardiothoracic Intensive Care, Pierre Zobda-Quitman, Martinique, Department of Anesthesiology and Critical Care, Guillaume and Rene Laennec Hospital, CHU Nantes, Nantes, Severe Burn Intensive Care Unit, Hotel Dieu, CHU Nantes, Nantes, Department of Anesthesiology and Critical Care, Hotel Dieu, CHU Nantes, Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Nancy, Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Bichat (AP/ HP), Paris, Department of Anesthesiology and Critical Care, Severe Burn Unit, Centre Hospitalier Universitaire de Lariboisiere (AP/HP), Paris, Anaesthesia Intensive Care Unit, Centre Hospitalier Universitaire de Saint Louis (AP/ HP), Paris, Surgical Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, Neuro-Intensive Care Unit, Centre Hospitalier Universitaire, Poitiers, Intensive Care Unit, Department of Anesthesiology and Critical Care, Rangueil Hospital, Centre Hospitalier Universitaire, Toulouse, Department of Anesthesiology and Critical Care, Pontchaillou Hospital, CHU Rennes, Rennes, Department of Anesthesiology and Critical Care, CHU Saint Etienne, Saint Etienne, Department of Anesthesiology, Intensive care and Perioperative medicine - Hautepierre Hospital, Strasbourg, Microbiotas Hosts Antibiotics Bacterial Resistances (MiHAR), Université de Nantes, Nantes, DRCI, Plateforme de Méthodologie et de Biostatistique, CHU Nantes, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), MORNET, Dominique, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle Anesthésie Réanimation [CHU de Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Pontchaillou [Rennes], Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Microbes évolution phylogénie et infections (MEPHI), and Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Adult, Microbiology (medical), medicine.medical_specialty, Critical Care, [SDV]Life Sciences [q-bio], Audit, Hospital-acquired pneumonia, law.invention, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, law, Intensive care, Humans, Medicine, 030212 general & internal medicine, Cluster randomised controlled trial, ComputingMilieux_MISCELLANEOUS, business.industry, Hazard ratio, Healthcare-Associated Pneumonia, 030208 emergency & critical care medicine, Length of Stay, medicine.disease, Intensive care unit, Hospitals, 3. Good health, Clinical trial, [SDV] Life Sciences [q-bio], Intensive Care Units, Infectious Diseases, Emergency medicine, business
Abstract

Background We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) can improve the outcomes of patients in intensive care units (ICUs). Methods This study was conducted at 35 ICUs in 30 hospitals. We included consecutive, adult patients hospitalized in ICUs for 3 days or more. After a 3-month baseline period followed by the dissemination of recommendations, an audit on the compliance to recommendations (audit period) was followed by a 3-month cluster-randomized trial. We randomly assigned ICUs to either receive audit and feedback (intervention group) or participate in a national registry (control group). The primary outcome was the duration of ICU stay. Results Among 1856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively. The composite measures of compliance were 47% (interquartile range [IQR], 38–56%) in the intervention group and 42% (IQR, 25–53%) in the control group (P = .001). As compared to the baseline period, the ICU lengths of stay were reduced by 3.2 days in the intervention period (P = .07) and by 2.8 days in the control period (P = .02). The durations of ICU stay were 7 days (IQR, 5–14 days) in the control group and 9 days (IQR, 5–20 days) in the intervention group (P = .10). After adjustment for unbalanced baseline characteristics, the hazard ratio for being discharged alive from the ICU in the control group was 1.17 (95% confidence interval, .69–2.01; P = .10). Conclusions The publication of French guidelines for HAP was associated with a reduction of the ICU length of stay. However, the realization of an audit to improve their application did not further improve outcomes. Clinical Trials Registration NCT03348579.

Published
2020

5. 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

6. Tailored multicomponent program for discomfort reduction in critically ill patients may decrease post-traumatic stress disorder in general ICU survivors at 1 year

Author

Pierre, Kalfon, Marine, Alessandrini, Mohamed, Boucekine, Stéphanie, Renoult, Marie-Agnès, Geantot, Stéphanie, Deparis-Dusautois, Audrey, Berric, Olivier, Collange, Bernard, Floccard, Olivier, Mimoz, Amour, Julien, René, Robert, Juliette, Audibert, Anne, Renault, Arnaud, Follin, Didier, Thevenin, Nathalie, Revel, Marion, Venot, René-Gilles, Patrigeon, Thomas, Signouret, Mélanie, Fromentin, Tarek, Sharshar, Coralie, Vigne, Julien, Pottecher, Quentin, Levrat, Achille, Sossou, Maïté, Garrouste-Orgeas, Jean-Pierre, Quenot, Claire, Boulle, Elie, Azoulay, Karine, Baumstarck, Pascal, Auquier, Yana, Chaban, Hôpital Louis Pasteur [Chartres], Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Hôpital Ambroise Paré [AP-HP], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre hospitalier de Troyes, Centre Hospitalier Intercommunal Toulon la Seyne sur mer, CHU Strasbourg, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), 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), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHRU Brest - Service de Réanimation Médicale (CHU - BREST - Réa Med), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Service d'Anesthésie-Réanimation [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Centre Hospitalier de Lens, Hôpital Pasteur [Nice] (CHU), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre hospitalier d'Auxerre (CHA), Hôpital Européen de Marseille (HEM), Hôpital Cochin [AP-HP], Service médical des soins intensifs [CHU Raymond Poincaré], Hôpital Raymond Poincaré [AP-HP], Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Hôpital de Hautepierre [Strasbourg], Hopital saint louis (LA ROCHELLE - Hôpital Saint Louis), CH La Rochelle, Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Centre hospitalier Saint-Joseph [Paris], Service de Réanimation Médicale (CHU de Dijon), Centre Hospitalier [Douai, Nord], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Centre Hospitalier d'Auxerre

Subjects
Male, [SDV]Life Sciences [q-bio], Critical Care and Intensive Care Medicine, law.invention, Cohort Studies, Stress Disorders, Post-Traumatic, 0302 clinical medicine, Randomized controlled trial, law, Patient-Centered Care, Surveys and Questionnaires, Health care, Medicine, Prospective Studies, Survivors, Patient Comfort, Patient-reported outcome, Aged, 80 and over, Simplified Acute Physiology Score, Traumatic stress, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Middle Aged, Intensive care unit, 3. Good health, Hospitalization, Intensive Care Units, Tailored interventions, Female, Discomfort, Cohort study, Adult, medicine.medical_specialty, Tailored program, Critical Illness, Statistics, Nonparametric, 03 medical and health sciences, Humans, Aged, Post-traumatic stress disorder, business.industry, Critically ill, 030208 emergency & critical care medicine, Critical care, 030228 respiratory system, Emergency medicine, ICU, Quality of Life, Observational study, business, Program Evaluation
Abstract

International audience; Purpose: Reducing discomfort in the intensive care unit (ICU) should have a positive effect on long-term outcomes. This study assessed whether a tailored multicomponent program for discomfort reduction was effective in reducing post-traumatic stress disorder (PTSD) symptoms at 1 year in general ICU survivors.Methods: This study is a prospective observational comparative effectiveness cohort study involving 30 ICUs. It was an extension of the IPREA3 study, a cluster-randomized controlled trial designed to assess the efficacy of a tailored multicomponent program to reduce discomfort in critically ill patients. The program included assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to the healthcare team, and site-specific tailored interventions. The exposure was the implementation of this program. The eligible patients were exposed versus unexposed general adult ICU survivors. The prevalence of substantial PTSD symptoms at 1 year was assessed based on the Impact of Event Scale-Revised (IES-R).Results: Of the 1537 ICU survivors included in the study, 475 unexposed patients and 344 exposed patients had follow-up data at 1 year: 57 (12.0%) and 21 (6.1%) presented with PTSD at 1 year, respectively (p = 0.004). Considering the clustering and after adjusting for age, gender, McCabe classification, and ICU-related self-perceived overall discomfort score, exposed patients were significantly less likely than unexposed patients to have substantial PTSD symptoms at 1 year (p = 0.015).Conclusions: Implementation of a tailored multicomponent program in the ICU that has proved to be effective for reducing self-perceived discomfort in general adult ICU survivors also reduced the prevalence of substantial PTSD symptoms at 1 year.

Published
2018

7. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial

Author

Pierre, Kalfon, Karine, Baumstarck, Philippe, Estagnasie, Marie-Agnès, Geantot, Audrey, Berric, Georges, Simon, Bernard, Floccard, Thomas, Signouret, Mohamed, Boucekine, Mélanie, Fromentin, Martine, Nyunga, Achille, Sossou, Marion, Venot, René, Robert, Arnaud, Follin, Juliette, Audibert, Anne, Renault, Maïté, Garrouste-Orgeas, Olivier, Collange, Quentin, Levrat, Isabelle, Villard, Didier, Thevenin, Julien, Pottecher, René-Gilles, Patrigeon, Nathalie, Revel, Coralie, Vigne, Elie, Azoulay, Olivier, Mimoz, Pascal, Auquier, Yana, Chaban, Hôpital Louis Pasteur [Chartres], Centre d'études et de recherche sur les services de santé et la qualité de vie (CEReSS), Aix Marseille Université (AMU), Clinique Ambroise Paré, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Intercommunal Toulon la Seyne sur mer, Centre hospitalier de Troyes, Hôpital Edouard Herriot [CHU - HCL], Hospices Civils de Lyon (HCL), Hôpital Européen de Marseille (HEM), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier de Roubaix, Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Hopital Saint-Louis [AP-HP] (AP-HP), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service d'Anesthésie-Réanimation [CHU HEGP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), CHRU Brest - Service de Réanimation Médicale (CHU - BREST - Réa Med), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre hospitalier Saint-Joseph [Paris], CHU Strasbourg, Hopital saint louis (LA ROCHELLE - Hôpital Saint Louis), CH La Rochelle, Hôpital Beaujon [AP-HP], Centre Hospitalier de Lens, Centre hospitalier d'Auxerre (CHA), Hôpital Pasteur [Nice] (CHU), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), and Centre Hospitalier d'Auxerre

Subjects
Male, medicine.medical_specialty, Tailored program, medicine.medical_treatment, Critical Illness, [SDV]Life Sciences [q-bio], Psychological intervention, Critical Care and Intensive Care Medicine, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Intensive care, Anesthesiology, Health care, Medicine, Humans, 030212 general & internal medicine, Patient-reported outcome, Aged, Pain Measurement, Mechanical ventilation, Aged, 80 and over, business.industry, 030208 emergency & critical care medicine, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, 3. Good health, Intensive Care Units, Critical care, ICU, Physical therapy, Quality of Life, Female, Perception, Self Report, business, Cluster-randomized controlled trial, Discomfort, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was − 7.00 (95% CI − 9.89 to − 4.11, p

Published
2017

8. Epidural analgesia in critically ill patients with acute pancreatitis: the multicentre randomised controlled EPIPAN study protocol

Author

Etienne Escudier, Laurence Roszyk, Achille Sossou, Vincent Sapin, Philippe Guerci, Elodie Caumon, Matthieu Jabaudon, Pierre-François Laterre, Bruno Pereira, Stéphanie Bulyez, Etienne Imhoff, C.-P. Heidegger, Jean-Michel Constantin, Samir Jaber, Lise Bernard, Pierre-Eric Danin, Pierre-Marie Bertrand, Dominique Morand, Russell Chabanne, Jean-Yves Lefrant, Leo Buhler, CHU Clermont-Ferrand, Department of Clinical Research and Innovation (DRCI), CHU Clermont-Ferrand, Department of Perioperative Medicine, CHU Clermont-Ferrand, Department of Medical Biochemistry and Molecular Biology, CHU Clermont-Ferrand, 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), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Intensive Care Unit, Cannes general hospital, Cannes, Intensive Care Unit, St Luc University Hospital, Faculté de Médecine [Nancy], Université de Lorraine (UL), Inserm U1065, Centre Méditerranéen de Médecine Moléculaire, Intensive Care Unit, Annecy Genevois general hospital, Annecy, Department of Anesthesiology and Critical Care Medicine, Emile-Roux general hospital, Le Puy-en-Velay, Laboratoire de Biochimie, Centre Hospitalier Universitaire de Clermont-Ferrand, Direction de la recherche clinique et de l’innovation [CHU Clermont-Ferrand] (DRCI), Service d'Anésthésie Réanimation [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Service de Biochimie et Génétique Moléculaire [CHU Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)

Subjects
Epidural analgesia, medicine.medical_treatment, Lung injury, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Protocol, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Medicine, Intensive care unit, Epidural administration, ComputingMilieux_MISCELLANEOUS, Mechanical ventilation, Randomised controlled trial, ddc:617, business.industry, Intensive Care, General Medicine, medicine.disease, 3. Good health, Acute pancreatitis, Respiratory failure, Anesthesia, Pancreatitis, 030211 gastroenterology & hepatology, business
Abstract

Background Acute pancreatitis (AP) is associated with high morbidity and mortality in its most severe forms. Most patients with severe AP require intubation and invasive mechanical ventilation, frequently for more than 7 days, which is associated with the worst outcome. Recent increasing evidence from preclinical and clinical studies support the beneficial effects of epidural analgesia (EA) in AP, such as increased gut barrier function and splanchnic, pancreatic and renal perfusion, decreased liver damage and inflammatory response, and reduced mortality. Because recent studies suggest that EA might be a safe procedure in the critically ill, we sought to determine whether EA reduced AP-associated respiratory failure and other major clinical outcomes in patients with AP. Methods and analysis The Epidural Analgesia for Pancreatitis (EPIPAN) trial is an investigator-initiated, prospective, multicentre, randomised controlled two-arm trial with assessor-blinded outcome assessment. The EPIPAN trial will randomise 148 patients with AP requiring admission to an intensive care unit (ICU) to receive EA (with patient-controlled epidural administration of ropivacaine and sufentanil) combined with standard care based on current recommendations on the treatment of AP (interventional group), or standard care alone (reference group). The primary outcome is the number of ventilator-free days at day 30. Secondary outcomes include main complications of AP (eg, organ failure and mortality, among others), levels of biological markers of systemic inflammation, epithelial lung injury, renal failure, and healthcare-associated costs. Ethics and dissemination The study was approved by the appropriate ethics committee ( CPP Sud-Est VI ). Informed consent is required. If the combined application of EA and standard care proves superior to standard care alone in patients with AP in the ICU, the use of EA may become standard practice in experienced centres, thereby decreasing potential complications related to AP and its burden in critically ill patients. The results will be disseminated in a peer-reviewed journal. Trial registration number NCT02126332.

Published
2017

9. Epidural analgesia in the intensive care unit: An observational series of 121 patients

Author

Jean-Michel Constantin, Pierre-Marie Bertrand, Achille Sossou, Lassane Zanre, Francois Brenas, Russell Chabanne, Matthieu Jabaudon, Christian Chartier, Sophie Kauffmann, Etienne Imhoff, Renaud Guérin, and Jean-Etienne Bazin

Subjects
Anesthesia, Epidural, Male, Catheters, Epidural abscess, Critical Care, Pain, Critical Care and Intensive Care Medicine, law.invention, law, medicine, Humans, Pain Management, Prospective Studies, Cross Infection, Pain, Postoperative, business.industry, Incidence (epidemiology), General Medicine, Perioperative, Middle Aged, medicine.disease, Intensive care unit, Discontinuation, Intensive Care Units, Anesthesiology and Pain Medicine, Treatment Outcome, Pancreatitis, SAPS II, Anesthesia, Feasibility Studies, Wounds and Injuries, Observational study, Female, business
Abstract

Background Epidural analgesia (EA) has been more investigated during the perioperative period than in the intensive care unit (ICU) setting. Recent studies support beneficial effects for EA beyond analgesia itself. However, data on feasibility and safety are still lacking in the ICU. Our goal was to assess the feasibility and practice of EA in ICU patients. Methods Multicentre observational study in 3 ICUs over a 10-month period. Goals were to report the incidence of EA-related complications and EA duration. All ICU patients receiving EA were included, whether EA was initiated in the ICU or elsewhere, e.g. in the operating room. Demographics, clinical and biological data were prospectively recorded. Epidural catheter tips were sent to the microbiology laboratory for culture. Results One hundred and twenty-one patients were included (mean age 60 years), with mean SOFA and median SAPS II scores of 3.2 and 32, respectively. Reasons for EA initiation included trauma (14%), postoperative pain management after major surgery (42%), and pancreatitis (31%). No EA-related neurologic complication was recorded, and one case of epidural abscess is discussed. No other EA-related infectious complications were observed. Median duration of EA was 11 days. Reasons for EA discontinuation included efficient analgesia without EA (60%) and accidental catheter removal (17%). 22% of epidural catheter cultures were positive for skin flora bacteria. Conclusion EA seems feasible in the ICU. Its apparent safety should be further validated in larger cohorts, but these preliminary results may stimulate more interest in the assessment of potential benefits associated with EA in the ICU setting.

Published
2014

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