Intracranial pressure monitoring with and without brain tissue oxygen pressure monitoring for severe traumatic brain injury in France (OXY-TC): an open-label, randomised controlled superiority trial
- Type de publi. : Article dans une revue
- Date de publi. : 01/11/2023
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Auteurs :
Jean-François PayenYoann LauneyRussell ChabanneSamuel GayGilles FranconyLaurent GergeleEmmanuel VegaAmbroise MontcriolDavid CouretVincent CottenceauSebastien Pili-FlouryClement GakubaEmmanuelle HammadGerard AudibertJulien PottecherClaire Dahyot-FizelierLamine AbdennourTobias GaussMarion RichardAntoine VilotitchJean-Luc BossonPierre BouzatMarie-Cecile FevreClotilde SchilteOlivier VincentMarie-Christine HéraultThomas MistralThibaut Trouve-BuissonJulien PicardDominique FalconSamuel BersingerClément MoureyAnaïs AdolleSamia SalahPauline ManhesAngélina PolletFrédéric GrecoKevin ChalardBailleul AndréaLionel VellyNicolas BruderImane InalClément MagandLaetitia BurnolJérôme MorelAnaèle PregnyJean-Christophe FerreElise BannierThomas LebouvierSophie CaradecClaire-Marie DrevetAbdelouaid NadjiRomain LewandowskiFrédéric DaillerRomain CarrillonFlorent GobertThomas RitzenthalerMathilde LeclercqNathalie DumontClaire CharpentierIonel AlbNatalie de SaNicolas DeclerckPierre BoussemartJulie BelletEric Meaudre-DesgouttesErwan d'ArandaPierre EsnaultCamille CharruauRémy BellierThierry BenardElsa CariseSabrina SeguinJean Yves LefrantAurélien DauratAudrey AmbertMarie LeboucSerge HautefeuilleEtienne EscudierFabrice BingBernard CosserantRomain GrobostCamille BoissyMarc BegardAdrien GuyotKevin LagardeElodie CaumonThomas GeeraertsMaxime PommierEdouard NaboulsiMaxime BeilvertElodie ParryMarc LeoneLaurent ZieleskiewiczGary DuclosCharlotte ArbelotIchai CaroleQuintard HervéDiop AminataLouis PuybassetGregory TorkomianMagdalena SzczotStephane KremerGuillaume BeckerStephane HecketsweilerDejan IlicLucie VettorettiColine GrisottoRomain AsmolovVincent EhingerNathalie LaquayVirginie ChevallierZahra MahlalSigismond LasockiAnne-Sylvie ScholastiqueThomas GaillardSoizic GergaudEmmanuel BarbierFlorence TahonAlexandre KrainikMichel DojatIrène TropresBernard VigueLaura LeoVincent PiriouAntoine CoquerelJean-Luc CracowskiFrancois ProustMichel Mallaret
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Organismes :
[GIN] Grenoble Institut des Neurosciences
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
CHU Clermont-Ferrand
ANTE-INSERM U836, équipe 5, Neuroimagerie fonctionnelle et perfusion cérébrale
[GIN] Grenoble Institut des Neurosciences
Unité de soins intensifs médico-chirurgicaux [CHU Saint-Etienne]
Centre Hospitalier Régional Universitaire [CHU Lille]
Diabète athérothrombose et thérapies Réunion Océan Indien
Centre Hospitalier Universitaire de La Réunion
CHU Bordeaux
Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
Comité éthique SFAR
Service Anesthésie et Réanimation [Hôpital Nord - APHM]
Comité éthique SFAR
Hôpital de Hautepierre [Strasbourg]
Pharmacologie des anti-infectieux et antibiorésistance [U 1070]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Université de Poitiers - Faculté de Médecine et de Pharmacie
CHU Pitié-Salpêtrière [AP-HP]
Université Grenoble Alpes - UFR Médecine
Paris School of Economics
Université Catholique de Louvain = Catholic University of Louvain
Centre Hospitalier Universitaire [CHU Grenoble]
Life Science Analytics Elsevier
Centre Hospitalier Universitaire [CHU Grenoble]
Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
- Publié dans The Lancet Neurology le 27/10/2020
Résumé : Background: Optimisation of brain oxygenation might improve neurological outcome after traumatic brain injury. The OXY-TC trial explored the superiority of a strategy combining intracranial pressure and brain tissue oxygen pressure (PbtO2) monitoring over a strategy of intracranial pressure monitoring only to reduce the proportion of patients with poor neurological outcome at 6 months. Methods: We did an open-label, randomised controlled superiority trial at 25 French tertiary referral centres. Within 16 h of brain injury, patients with severe traumatic brain injury (aged 18-75 years) were randomly assigned via a website to be managed during the first 5 days of admission to the intensive care unit either by intracranial pressure monitoring only or by both intracranial pressure and PbtO2 monitoring. Randomisation was stratified by age and centre. The study was open label due to the visibility of the intervention, but the statisticians and outcome assessors were masked to group allocation. The therapeutic objectives were to maintain intracranial pressure of 20 mm Hg or lower, and to keep PbtO2 (for those in the dual-monitoring group) above 20 mm Hg, at all times. The primary outcome was the proportion of patients with an extended Glasgow Outcome Scale (GOSE) score of 1-4 (death to upper severe disability) at 6 months after injury. The primary analysis was reported in the modified intention-to-treat population, which comprised all randomly assigned patients except those who withdrew consent or had protocol violations. This trial is registered with ClinicalTrials.gov, NCT02754063, and is completed. Findings: Between June 15, 2016, and April 17, 2021, 318 patients were randomly assigned to receive either intracranial pressure monitoring only (n=160) or both intracranial pressure and PbtO2 monitoring (n=158). 27 individuals with protocol violations were not included in the modified intention-to-treat analysis. Thus, the primary outcome was analysed for 144 patients in the intracranial pressure only group and 147 patients in the intracranial pressure and PbtO2 group. Compared with intracranial pressure monitoring only, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with GOSE score 1-4 (51% [95% CI 43-60] in the intracranial pressure monitoring only group vs 52% [43-60] in the intracranial pressure and PbtO2 monitoring group; odds ratio 1·0 [95% CI 0·6-1·7]; p=0·95). Two (1%) of 144 participants in the intracranial pressure only group and 12 (8%) of 147 participants in the intracranial pressure and PbtO2 group had catheter dysfunction (p=0.011). Six patients (4%) in the intracranial pressure and PbtO2 group had an intracrebral haematoma related to the catheter, compared with none in the intracranial pressure only group (p=0.030). No significant difference in deaths was found between the two groups at 12 months after injury. At 12 months, 33 deaths had occurred in the intracranial pressure group: 25 (76%) were attributable to the brain trauma, six (18%) were end-of-life decisions, and two (6%) due to sepsis. 34 deaths had occured in the intracranial pressure and PbtO2 group at 12 months: 25 (74%) were attributable to the brain trauma, six (18%) were end-of-life decisions, one (3%) due to pulmonary embolism, one (3%) due to haemorrhagic shock, and one (3%) due to cardiac arrest. Interpretation: After severe non-penetrating traumatic brain injury, intracranial pressure and PbtO2 monitoring did not reduce the proportion of patients with poor neurological outcome at 6 months. Technical failures related to intracerebral catheter and intracerebral haematoma were more frequent in the intracranial pressure and PbtO2 group. Further research is needed to assess whether a targeted approach to multimodal brain monitoring could be useful in subgroups of patients with severe traumatic brain injury-eg, those with high intracranial pressure on admission.
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