أعرض في EDS

Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol

التفاصيل البيبلوغرافية
العنوان: Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol
المؤلفون: Laurent Gergelé, Kristina Skaare, Marion Richard, Emmanuel Barbier, Bernard Vigué, Gilles Francony, Jean-François Payen, Pierre Bouzat, Nicolas Bruder, Claire Dahyot-Fizelier, Gérard Audibert, Jean Luc Bosson, Thomas Geeraerts, Louis Puybasset
المساهمون: [GIN] Grenoble Institut des Neurosciences (GIN), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Aix Marseille Université (AMU), Assistance Publique - Hôpitaux de Marseille (APHM), Pharmacologie des anti-infectieux (PHAR), Université de Poitiers-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, CHU Toulouse [Toulouse], Hôpital privé de la Loire, Service d'Anesthésie réanimation [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université - Faculté de Médecine (SU FM), Sorbonne Université (SU), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Centre Hospitalier Universitaire [Grenoble] (CHU), Techniques pour l'Evaluation et la Modélisation des Actions de la Santé (TIMC-IMAG-ThEMAS), Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications Grenoble - UMR 5525 (TIMC-IMAG), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS)-Université Grenoble Alpes (UGA)-Institut polytechnique de Grenoble - Grenoble Institute of Technology (Grenoble INP ), Université Grenoble Alpes (UGA), ANR-19-P3IA-0003,MIAI,MIAI @ Grenoble Alpes(2019), Université de Toulouse (UT), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)
المصدر: BMJ Open
BMJ Open, BMJ Publishing Group, 2020, 10 (8), pp.e040550. ⟨10.1136/bmjopen-2020-040550⟩
BMJ Open, Vol 10, Iss 8 (2020)
BMJ Open, 2020, 10 (8), pp.e040550. ⟨10.1136/bmjopen-2020-040550⟩
بيانات النشر: HAL CCSD, 2020.
سنة النشر: 2020
مصطلحات موضوعية: medicine.medical_specialty, Intracranial Pressure, Traumatic brain injury, Neurosurgery, Glasgow Outcome Scale, 03 medical and health sciences, 0302 clinical medicine, Superiority Trial, Brain Injuries, Traumatic, medicine, Humans, Multicenter Studies as Topic, 030212 general & internal medicine, adult intensive & critical care, Monitoring, Physiologic, Randomized Controlled Trials as Topic, Intracranial pressure, business.industry, Mortality rate, Intensive Care, Brain, General Medicine, Institutional review board, medicine.disease, 3. Good health, Emergency medicine, trauma management, Medicine, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Intracranial Hypertension, business, Early phase, 030217 neurology & neurosurgery
الوصف: IntroductionIntracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO2) and ICP during the first 5 days following severe TBI.Methods and analysisMulticentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO2group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO2group is managed to maintain PbtO2≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.Ethics and disseminationThis study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrialsNCT02754063on 28 April 2016 (pre-results).
اللغة: English
تدمد: 2044-6055
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a95b0c1af35a4d6d67a5671901fa36e4
https://hal.sorbonne-universite.fr/hal-02940649/document
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....a95b0c1af35a4d6d67a5671901fa36e4
قاعدة البيانات: OpenAIRE
الوصف
تدمد:20446055