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1. Multicentre randomised controlled trial to investigate the usefulness of continuous pneumatic regulation of tracheal cuff pressure for reducing ventilator-associated pneumonia in mechanically ventilated severe trauma patients: the AGATE study protocol

Author

Karim Asehnoune, Catherine Paugam, Olivier Mimoz, Jean-Yves Lefrant, Denis Frasca, Carole Ichai, Nicolas Marjanovic, Jean-Michel Constantin, Dominique Falcon, Claire Dahyot-Fizelier, Marc Leone, Sigismond Lasocki, Julien Pottecher, Jérémy Guenezan, Sabrina Seguin, Benoit Veber, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Hôpital de la Milétrie, MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours (UT)-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), Thérapeutiques cliniques et expérimentales des infections (EA 3826) (EA 3826), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Biologie Neurovasculaire et Mitochondriale Intégrée (BNMI), Bioénergétique fondamentale et appliquée, Université Joseph Fourier - Grenoble 1 (UJF)-Institut National de la Santé et de la Recherche Médicale (INSERM), Unité de réanimation médicale [CHU de Carémeau, Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Caractéristiques féminines des dysfonctions des interfaces cardio-vasculaires (EA 2992), Université Montpellier 1 (UM1)-Université de Montpellier (UM), Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes (URMITE), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR48, Institut des sciences biologiques (INSB-CNRS)-Institut des sciences biologiques (INSB-CNRS)-Centre National de la Recherche Scientifique (CNRS), Service d'Anesthésie Réanimation Chirurgicale [Poitiers], Mitochondries, stress oxydant et protection musculaire (Strasbourg), Mitochondrie, stress oxydant et protection musculaire (MSP), Université de Strasbourg (UNISTRA)-Université de Strasbourg (UNISTRA), Surgical Intensive Care Unit, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, Service de réanimation médicale [CHU Rouen], Hôpital Charles Nicolle [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), 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), CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université d'Angers (UA), INSB-INSB-Centre National de la Recherche Scientifique (CNRS), Hôpital Charles Nicolle [Rouen]-CHU Rouen, 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]), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, and Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Critical Illness, Pilot Projects, wounds and injuries, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Risk Factors, medicine, Clinical endpoint, Intubation, Intratracheal, Pressure, Protocol, Humans, pneumonia, Glasgow Coma Scale, Intensive care medicine, lung diseases, Mechanical ventilation, Continuous Positive Airway Pressure, business.industry, Ventilator-associated pneumonia, Intensive Care, Pneumonia, Ventilator-Associated, 030208 emergency & critical care medicine, General Medicine, medicine.disease, pneumonia, ventilator-asssociated, Intensive care unit, 3. Good health, respiratory tract diseases, Clinical trial, Pneumonia, Intensive Care Units, 030228 respiratory system, Cuff, Female, business
Abstract

IntroductionSevere trauma represents the leading cause of mortality worldwide. While 80% of deaths occur within the first 24 hours after trauma, 20% occur later and are mainly due to healthcare-associated infections, including ventilator-associated pneumonia (VAP). Preventing underinflation of the tracheal cuff is recommended to reduce microaspiration, which plays a major role in the pathogenesis of VAP. Automatic devices facilitate the regulation of tracheal cuff pressure, and their implementation has the potential to reduce VAP. The objective of this work is to determine whether continuous regulation of tracheal cuff pressure using a pneumatic device reduces the incidence of VAP compared with intermittent control in severe trauma patients.Methods and analysisThis multicentre randomised controlled and open-label trial will include patients suffering from severe trauma who are admitted within the first 24 hours, who require invasive mechanical ventilation to longer than 48 hours. Their tracheal cuff pressure will be monitored either once every 8 hours (control group) or continuously using a pneumatic device (intervention group). The primary end point is the proportion of patients that develop VAP in the intensive care unit (ICU) at day 28. The secondary end points include the proportion of patients that develop VAP in the ICU, early (≤7 days) or late (>7 days) VAP, time until the first VAP diagnosis, the number of ventilator-free days and antibiotic-free days, the length of stay in the ICU, the proportion of patients with ventilator-associated events and that die during their ICU stay.Ethics and disseminationThis protocol has been approved by the ethics committee of Poitiers University Hospital, and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registrationClinical TrialsNCT02534974

Published
2017

2. COBI (COntinuous hyperosmolar therapy for traumatic Brain-Injured patients) trial protocol: a multicentre randomised open-label trial with blinded adjudication of primary outcome

Author

Karim Asehnoune, Claire Dahyot-Fizelier, Fanny Feuillet, Philippe Seguin, Olivier Huet, P.-F. Perrigault, Francis Remerand, Tarek Sharshar, Jean Denis Moyer, Sigismond Lasocki, Antoine Roquilly, Thomas Geeraerts, Service d'anesthésie et réanimation chirurgicale [Nantes], Hôtel-Dieu-Centre hospitalier universitaire de Nantes (CHU Nantes), CHU d'Angers [Département Urgences], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Hôpital Beaujon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHRU Brest - Département d'Anesthésie Réanimation (CHU - BREST - DAR), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Département d'anesthésie-réanimation[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier], Service d'Anesthésie Réanimation Chirurgicale [Poitiers], 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), Service d'Anesthésie Réanimation [Rennes], CHU Pontchaillou [Rennes], Centre Hospitalier Sainte Anne [Paris], Pôle Anesthésie Réanimation, Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse], Toulouse Neuro Imaging Center (ToNIC), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Biostatistique, Recherche Clinique et Mesures Subjectives en Santé, Université de Nantes (UN), Pôle Anesthésie Réanimation [CHU de Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Toulouse Mind & Brain Institut (TMBI), Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, HAL-UPMC, Gestionnaire, Hôpital Beaujon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), and Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS)

Subjects
law.invention, 0302 clinical medicine, Randomized controlled trial, Clinical Protocols, law, Brain Injuries, Traumatic, Mannitol, Single-Blind Method, Stage (cooking), sodium, Cause of death, brain oedema, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Glasgow Outcome Scale, traumatic brain injury, hypertonic, General Medicine, trial, Intensive care unit, 3. Good health, Intensive Care Units, trauma, intracranial hypertension, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], hyperosmolar therapy, medicine.medical_specialty, Critical Care, Traumatic brain injury, saline solution, brain injured, 03 medical and health sciences, medicine, Humans, Glasgow Coma Scale, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], protocol, Risk factor, Intensive care medicine, Saline Solution, Hypertonic, therapy, business.industry, Osmolar Concentration, Intensive Care, 030208 emergency & critical care medicine, medicine.disease, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Emergency medicine, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

IntroductionTraumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI. Continuous infusion of hyperosmolar therapy has been proposed for the prevention and the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long-term outcomes of patients with TBI is uncertain. The aim of the COBI study (number clinicaltrial.gov 03143751, pre-results stage) is to assess the efficiency and the safety of continuous hyperosmolar therapy in patients with TBI.Methods and analysisThe COBI (COntinuous hyperosmolar therapy in traumatic Brain-Injured patients) trial is a multicentre, randomised, controlled, open-label, two-arms study with blinded adjudication of primary outcome. Three hundred and seventy patients hospitalised in intensive care unit with a TBI (Glasgow Coma Scale ≤12 and abnormal brain CT scan) are randomised in the first 24 hours following trauma to standard care or continuous hyperosmolar therapy (20% NaCl) plus standard care. Continuous hyperosmolar therapy is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to prevent ICH. The primary outcome is the score on the Extended Glasgow Outcome Scale at 6 months. The treatment effect is estimated with ordinal logistic regression adjusted for prespecified prognostic factors and expressed as a common OR.Ethics and disseminationThe COBI trial protocol has been approved by the ethics committee of Paris Ile de France VIII and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals. The COBI trial is the first randomised controlled trial powered to investigate whether continuous hyperosmolar therapy in patients with TBI improve long-term recovery.Trial registration numberTrial registration number isNCT03143751.

Published
2017

3. Medical pre-hospital management reduces mortality in severe blunt trauma: a prospective epidemiological study

Author

Christine Binquet, Marc Freysz, Claude Jacquot, Fatima Rayeh, Jean Michel Yeguiayan, Claire Bonithon-Kopp, Delphine Garrigue, Claude Martin, Jacques Duranteau, Bruno Riou, Service d'Anesthésie et Réanimation (hôpital général, CHU Dijon), Hôpital général (CHU Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Fédération des Urgences - SAMU59, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Lipides - Nutrition - Cancer (U866) (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon (ENSBANA), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques (CIC-EC), Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Institut National de la Santé et de la Recherche Médicale (INSERM), Clinique de réanimation médicale, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-Hôpital Michallon, Service d'anesthésie et réanimation, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Bicêtre, Centre de traumatologie et Département d'Anesthésie Réanimation, Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille (APHM)-Hôpital nord, Service d'Anesthésie Réanimation Chirurgicale [Poitiers], Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service d'Accueil des Urgences [CHU Pitié-Salpêtrière], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), This study was supported by the Programme Hospitalier de Recherche Clinique 2003 of the French Ministry of Health (National PHRC), the Société Française d'Anesthésie Réanimation (SFAR) and the Centre Hospitalier Universitaire de Dijon., The FIRST (French Intensive Care Recorded In Severe Trauma) Study Group, Université de la Méditerranée - Aix-Marseille 2-Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E)-Assistance Publique - Hôpitaux de Marseille (APHM), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Anesthésie et Réanimation, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Lipides - Nutrition - Cancer (U866) ( LNC ), Université de Bourgogne ( UB ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Ecole Nationale Supérieure de Biologie Appliquée à la Nutrition et à l'Alimentation de Dijon ( ENSBANA ), Centre d'Investigation Clinique 1432 (Dijon) - Epidemiologie Clinique/Essais Cliniques ( CIC-EC ), Université de Bourgogne ( UB ) -Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Université Joseph Fourier - Grenoble 1 ( UJF ) -CHU Grenoble-Hôpital Albert Michallon, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Bicêtre, Université de la Méditerranée - Aix-Marseille 2-Assistance Publique - Hôpitaux de Marseille ( APHM ) -Hôpital nord, CHU de Poitiers, Service d'Accueil des Urgences, Université Pierre et Marie Curie - Paris 6 ( UPMC ) -Assistance publique - Hôpitaux de Paris (AP-HP)-CHU Pitié-Salpêtrière [APHP], and BMC, Ed.

Subjects
Male, Emergency Medical Services, Time Factors, MESH : Aged, MESH : Prospective Studies, Poison control, Critical Care and Intensive Care Medicine, 0302 clinical medicine, Injury Severity Score, Patient Admission, Emergency medical services, [ SHS.INFO ] Humanities and Social Sciences/Library and information sciences, 030212 general & internal medicine, Hospital Mortality, Prospective Studies, Prospective cohort study, MESH: Treatment Outcome, MESH: Aged, MESH: Middle Aged, Mortality rate, [ SDV.SPEE ] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH : Patient Admission, MESH : Adult, Middle Aged, 3. Good health, MESH : Wounds and Injuries, Intensive Care Units, Treatment Outcome, Blunt trauma, MESH: Young Adult, MESH: Emergency Medical Services, MESH : Injury Severity Score, France, MESH: Firefighters, MESH : Intensive Care Units, Cohort study, MESH : Time Factors, Adult, medicine.medical_specialty, Adolescent, MESH : Male, [SHS.INFO]Humanities and Social Sciences/Library and information sciences, MESH: Injury Severity Score, MESH : Young Adult, MESH : Treatment Outcome, [SHS.INFO] Humanities and Social Sciences/Library and information sciences, MESH : Hospital Mortality, 03 medical and health sciences, Young Adult, Intensive care, MESH : Adolescent, medicine, Humans, MESH : Emergency Medical Services, MESH : Middle Aged, MESH: Hospital Mortality, Intensive care medicine, MESH : France, Aged, MESH: Adolescent, MESH: Humans, business.industry, MESH: Patient Admission, Research, MESH : Humans, MESH: Time Factors, 030208 emergency & critical care medicine, MESH: Adult, MESH: Male, MESH: Prospective Studies, MESH: France, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, MESH: Wounds and Injuries, Firefighters, Emergency medicine, Wounds and Injuries, MESH: Intensive Care Units, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, MESH : Firefighters, business
Abstract

International audience; INTRODUCTION: Severe blunt trauma is a leading cause of premature death and handicap. However, the benefit for the patient of pre-hospital management by emergency physicians remains controversial because it may delay admission to hospital. This study aimed to compare the impact of medical pre-hospital management performed by SMUR (Service Mobile d'Urgences et de Réanimation) with non-medical pre-hospital management provided by fire brigades (non-SMUR) on 30-day mortality. METHODS: The FIRST (French Intensive care Recorded in Severe Trauma) study is a multicenter cohort study on consecutive patients with severe blunt trauma requiring admission to university hospital intensive care units within the first 72 hours. Initial clinical status, pre-hospital life-sustaining treatments and Injury Severity Scores (ISS) were recorded. The main endpoint was 30-day mortality. RESULTS: Among 2,703 patients, 2,513 received medical pre-hospital management from SMUR, and 190 received basic pre-hospital management provided by fire brigades. SMUR patients presented a poorer initial clinical status and higher ISS and were admitted to hospital after a longer delay than non-SMUR patients. The crude 30-day mortality rate was comparable for SMUR and non-SMUR patients (17% and 15% respectively; P = 0.61). After adjustment for initial clinical status and ISS, SMUR care significantly reduced the risk of 30-day mortality (odds ratio (OR): 0.55, 95% CI: 0.32 to 0.94, P = 0.03). Further adjustments for the delay to hospital admission only marginally affected these results. CONCLUSIONS: This study suggests that SMUR management is associated with a significant reduction in 30-day mortality. The role of careful medical assessment and intensive pre-hospital life-sustaining treatments needs to be assessed in further studies.

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