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1. Methodological quality of multivariate prognostic models for intracranial haemorrhages in intensive care units: a systematic review

Author

Simon-Pimmel, Jeanne, Foucher, Yohann, Léger, Maxime, Feuillet, Fanny, Bodet-Contentin, Laetitia, Cinotti, Raphaël, Frasca, Denis, Dantan, Etienne, 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), Centre hospitalier universitaire de Nantes (CHU Nantes), Medical Intensive Care, Angers University Hospital, Nantes, France, Biostatistics and Methodology Unit, University Hospital Centre Nantes, Nantes, Pays de la Loire, France, Intensive Care Unit, Regional University Hospital Centre Tours, Tours, Centre, France, Anesthesia and Critical Care Department, University Hospital Centre Poitiers, Poitiers, France, Dantan, Etienne, and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
[STAT.ME] Statistics [stat]/Methodology [stat.ME], [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, statistics & research methods, Intensive Care, Prognosis, stroke, Intensive Care Units, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Medicine, Humans, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, neurosurgery, [STAT.ME]Statistics [stat]/Methodology [stat.ME], Intracranial Hemorrhages, adult intensive & critical care, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Objectives Patients with severe spontaneous intracranial haemorrhages, managed in intensive care units, face ethical issues regarding the difficulty of anticipating their recovery. Prognostic tools help clinicians in counselling patients and relatives and guide therapeutic decisions. We aimed to methodologically assess prognostic tools for functional outcomes in severe spontaneous intracranial haemorrhages. Data sources Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations, we conducted a systematic review querying Medline, Embase, Web of Science, and the Cochrane in January 2020. Study selection We included development or validation of multivariate prognostic models for severe intracerebral or subarachnoid haemorrhage. Data extraction We evaluated the articles following the CHecklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies and Transparent Reporting of multivariable prediction model for Individual Prognosis Or Diagnosis statements to assess the tools’ methodological reporting. Results Of the 6149 references retrieved, we identified 85 articles eligible. We discarded 43 articles due to the absence of prognostic performance or predictor selection. Among the 42 articles included, 22 did not validate models, 6 developed and validated models and 14 only externally validated models. When adding 11 articles comparing developed models to existing ones, 25 articles externally validated models. We identified methodological pitfalls, notably the lack of adequate validations or insufficient performance levels. We finally retained three scores predicting mortality and unfavourable outcomes: the IntraCerebral Haemorrhages (ICH) score and the max-ICH score for intracerebral haemorrhages, the SubArachnoid Haemorrhage International Trialists score for subarachnoid haemorrhages. Conclusions Although prognostic studies on intracranial haemorrhages abound in the literature, they lack methodological robustness or show incomplete reporting. Rather than developing new scores, future authors should focus on externally validating and updating existing scores with large and recent cohorts.

Published
2021

2. Early versus differed arterial catheterisation in critically ill patients with acute circulatory failure: a multicentre, open-label, pragmatic, randomised, non-inferiority controlled trial: the EVERDAC protocol

Author

Toufik Kamel, Damien Contou, Jean-Pierre Quenot, Alexandra Monnier, Thierry Boulain, Jean-Claude Lacherade, Maelle Martin, Sylvie Vimeux, Elsa Tavernier, Grégoire Muller, Solène Brunet Houdard, Florence Boissier, Stephan Ehrmann, Centre Hospitalier Régional d'Orléans (CHRO), Réseau CRICS-TRIGGERSEP [CHRU Tours] (F-CRIN research network), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre hospitalier Argenteuil (CH Argenteuil), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Trousseau [Tours], Centre d’Etude des Pathologies Respiratoires (CEPR), UMR 1100 (CEPR), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon, Centre hospitalier universitaire de Poitiers (CHU Poitiers), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Centre hospitalier de Montauban (CH Montauban), 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), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), and Malbec, Odile

Subjects
medicine.medical_specialty, [SDV]Life Sciences [q-bio], law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Informed consent, law, Medicine, health economics, 030212 general & internal medicine, adult intensive & critical care, Protocol (science), clinical trials, business.industry, 030208 emergency & critical care medicine, General Medicine, Arterial catheter, medicine.disease, Intensive care unit, Thrombosis, 3. Good health, Clinical trial, [SDV] Life Sciences [q-bio], Shock (circulatory), Emergency medicine, medicine.symptom, business
Abstract

IntroductionThe use of peripheral indwelling arterial catheter for haemodynamic monitoring is widespread in the intensive care unit and is recommended in patients with shock. However, there is no evidence that the arterial catheter could improve patient’s outcome, whereas the burden of morbidity generated is significant (pain, thrombosis, infections). We hypothesise that patients with shock may be managed without an arterial catheter.Methods and analysisThe EVERDAC study is an investigator-initiated, pragmatic, multicentre, randomised, controlled, open-label, non-inferiority clinical trial, comparing a less invasive intervention (ie, no arterial catheter insertion until felt absolutely needed, according to predefined safety criteria) or usual care (ie, systematic arterial catheter insertion in the early hours of shock). 1010 patients will be randomised with a 1:1 ratio in two groups according to the strategy. The primary outcome is all-cause mortality by 28 days after inclusion. A health economic analysis will be carried out.Ethics and disseminationThe study has been approved by the Ethics Committee (Comité de Protection des Personnes Île de France V, registration number 61606 CAT 2, 19 july 2018) and patients will be included after informed consent. The results will be submitted for publication in peer-reviewed journals.Trial registration numberNCT03680963.

Published
2021

3. 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

4. Skin antisepsis with chlorhexidine–alcohol versus povidone iodine–alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study

Author

Rodérick O’Neill, Catherine Pouzet, Sabrina Seguin, Diane Caillaud, Bertrand Drugeon, Clément Sénamaud, Denis Frasca, Jérémy Guenezan, Olivier Mimoz, Centre hospitalier universitaire de Poitiers (CHU Poitiers), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers, 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), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
Adult, Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], antiseptics, Antisepsis, medical devices, 03 medical and health sciences, Catheters, Indwelling, 0302 clinical medicine, prevention, healthcare-associated infection, Catheterization, Peripheral, Protocol, Central Venous Catheters, Humans, Medicine, 030212 general & internal medicine, Povidone-Iodine, Aged, Protocol (science), Catheter insertion, Ethanol, business.industry, Incidence, Chlorhexidine, General Medicine, Emergency department, Length of Stay, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Arterial catheter, 3. Good health, Catheter, Infectious Diseases, Catheter-Related Infections, Multivariate Analysis, Emergency medicine, Anti-Infective Agents, Local, Peripheral venous catheter, Equipment Failure, Female, Open label, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

IntroductionShort peripheral intravenous catheters (PVCs) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of mechanical, vascular or infectious complications, which prolongs hospitalisation and increases healthcare costs and mortality.Prevention of these complications is mainly based on the respect of hygiene rules and the use of biocompatible catheters. In critically ill patients, 2% chlorhexidine-alcohol is superior to 5% povidone iodine-alcohol for skin preparation before central venous and arterial catheters; whether this finding can be extended to PVC inserted in the wards remains speculative. Similarly, the use of new technologies such as catheters designed to minimise blood exposure, zero-reflux needleless connectors, disinfecting caps and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest to prevent PVC failure, but little scientific data support their routine use.Methods and analysisThe CLEAN 3 study is an open-label, single-centre, randomised, two-by-two factorial trial. One thousand patients visiting our emergency department and requiring hospital admission in the wards will be randomised to one of four strategies according to skin preparation and devices used. The two primary endpoints will be (1) the incidence of infectious complications related to the catheters (colonisation, local infection or bloodstream infection) and (2) the time between catheter insertion and catheter failure defined as any premature removal of PVC before end of treatment, other than for routine replacement.Ethics and disseminationThis protocol has been approved by an independent ethics committee 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 registration numberEudraCT 2018-A02535-50; NCT03757143.

Published
2019

5. Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial

Author

Ouldamer, Lobna, Bonastre, Julia, Brunet-Houdard, Solène, Body, Gilles, Giraudeau, Bruno, Caille, Agnès, Nutrition, croissance et cancer (U 1069) (N2C), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Bretonneau, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Faculté de Médecine, Université de Tours (UT), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), Department of Gynecology, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Centre d’Investigation Clinique [Tours] CIC 1415 (CIC ), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Francois Rabelais [Tours], PRES Centre-Val de Loire Université, 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), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau-Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), and Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques

Subjects
Adult, Adolescent, [SDV]Life Sciences [q-bio], Breast Neoplasms, Surgical Flaps, Young Adult, Postoperative Complications, Clinical Protocols, 80 and over, Protocol, Humans, Surgical Wound Infection, Mastectomy, Aged, Aged, 80 and over, Sutures, Suture Techniques, Middle Aged, Seroma, Axilla, Quality of Life, Drainage, Surgery, Female
Abstract

International audience; INTRODUCTION: Postoperative wound seroma is common after mastectomy. This complication is associated with significant impact on patient outcomes and healthcare costs. The optimal closure approach for seroma prevention remains unknown but some evidence suggests that quilting suture of the dead space could lower the incidence of seroma. The aim of this trial is to compare seroma formation using quilting suture versus conventional closure with drainage in patients undergoing mastectomy. METHODS AND ANALYSIS: This is a multicentre, superiority, randomised controlled trial in women undergoing mastectomy with or without axillary involvement. Exclusion criteria include indication of bilateral mastectomy or immediate reconstruction and any physical or psychiatric condition that could impair patient's ability to cooperate with postoperative data collection or that do not allow an informed consent. 320 participants will be randomised in a 1:1 ratio to receive either quilting suture or conventional wound closure with drain. The primary outcome is seroma requiring either aspiration or surgical intervention within 21\hspace0.25emdays following mastectomy. Secondary outcomes include seroma regardless of whether or not it requires an intervention, surgical site infection, pain score, cosmetic result, patient's quality of life, costs and cost-effectiveness. The primary analysis will be an intention-to treat analysis performed with a χ(2) test (or Fisher's exact test). ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. This study was approved by Tours Research ethics committee (CPP TOURS-Region Centre-Ouest 1, 2014-R20, 16 December 2014). Study findings will be published in peer-reviewed journals and presented at relevant national and international breast cancer conferences. TRIAL REGISTRATION NUMBER: NCT02263651.

Published
2016

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