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 - Archive ouverte HAL Access content directly
Journal Articles The Lancet Neurology Year : 2023

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

Jean-François Payen (1) , Yoann Launey (2) , Russell Chabanne (3) , Samuel Gay (4) , Gilles Francony (1) , Laurent Gergele (5) , Emmanuel Vega (6) , Ambroise Montcriol , David Couret (7, 8) , Vincent Cottenceau (9) , Sebastien Pili-Floury (10) , Clement Gakuba (11) , Emmanuelle Hammad (12) , Gerard Audibert (11) , Julien Pottecher (13) , Claire Dahyot-Fizelier (14, 15, 16) , Lamine Abdennour (17) , Tobias Gauss (18) , Marion Richard (19, 20) , Antoine Vilotitch (21) , Jean-Luc Bosson (22, 21, 23) , Pierre Bouzat , Marie-Cecile Fevre , Clotilde Schilte , Olivier Vincent , Marie-Christine Hérault , Thomas Mistral , Thibaut Trouve-Buisson , Julien Picard , Dominique Falcon , Samuel Bersinger , Clément Mourey , Anaïs Adolle , Samia Salah , Pauline Manhes , Angélina Pollet , Frédéric Greco , Kevin Chalard , Bailleul Andréa , Lionel Velly , Nicolas Bruder , Imane Inal , Clément Magand , Laetitia Burnol , Jérôme Morel (24) , Anaèle Pregny , Jean-Christophe Ferre , Elise Bannier , Thomas Lebouvier , Sophie Caradec , Claire-Marie Drevet , Abdelouaid Nadji , Romain Lewandowski , Frédéric Dailler , Romain Carrillon , Florent Gobert , Thomas Ritzenthaler , Mathilde Leclercq , Nathalie Dumont , Claire Charpentier , Ionel Alb , Natalie de Sa , Nicolas Declerck , Pierre Boussemart , Julie Bellet , Eric Meaudre-Desgouttes , Erwan d'Aranda , Pierre Esnault , Camille Charruau , Rémy Bellier , Thierry Benard , Elsa Carise , Sabrina Seguin , Jean Yves Lefrant , Aurélien Daurat , Audrey Ambert , Marie Lebouc , Serge Hautefeuille , Etienne Escudier , Fabrice Bing , Bernard Cosserant , Romain Grobost , Camille Boissy , Marc Begard , Adrien Guyot , Kevin Lagarde , Elodie Caumon , Thomas Geeraerts , Maxime Pommier , Edouard Naboulsi , Maxime Beilvert , Elodie Parry , Marc Leone , Laurent Zieleskiewicz , Gary Duclos , Charlotte Arbelot , Ichai Carole , Quintard Hervé , Diop Aminata , Louis Puybasset , Gregory Torkomian , Magdalena Szczot , Stephane Kremer , Guillaume Becker , Stephane Hecketsweiler , Dejan Ilic , Lucie Vettoretti , Coline Grisotto , Romain Asmolov , Vincent Ehinger , Nathalie Laquay , Virginie Chevallier , Zahra Mahlal , Sigismond Lasocki , Anne-Sylvie Scholastique , Thomas Gaillard , Soizic Gergaud , Emmanuel Barbier , Florence Tahon , Alexandre Krainik , Michel Dojat , Irène Tropres , Bernard Vigue , Laura Leo , Vincent Piriou , Antoine Coquerel , Jean-Luc Cracowski , Francois Proust , Michel Mallaret
1 GIN - [GIN] Grenoble Institut des Neurosciences
2 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
3 CHU Clermont-Ferrand
4 ANTE-INSERM U836, équipe 5, Neuroimagerie fonctionnelle et perfusion cérébrale
5 Unité de soins intensifs médico-chirurgicaux [CHU Saint-Etienne]
6 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
7 DéTROI - Diabète athérothrombose et thérapies Réunion Océan Indien
8 CHU La Réunion - Centre Hospitalier Universitaire de La Réunion
9 CHU Bordeaux
10 PCVP / CARDIO - Marqueurs pronostiques et facteurs de régulations des pathologies cardiaques et vasculaires - UFC ( UR 3920)
11 Comité éthique SFAR
12 Service Anesthésie et Réanimation [Hôpital Nord - APHM]
13 Hôpital de Hautepierre [Strasbourg]
14 PHAR2 [Poitiers] - Pharmacologie des anti-infectieux et antibiorésistance [U 1070]
15 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
16 Université de Poitiers - Faculté de Médecine et de Pharmacie
17 CHU Pitié-Salpêtrière [AP-HP]
18 UGA UFRM - Université Grenoble Alpes - UFR Médecine
19 PSE - Paris School of Economics
20 UCL - Université Catholique de Louvain = Catholic University of Louvain
21 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
22 Life Science Analytics Elsevier
23 TIMC - Translational Innovation in Medicine and Complexity / Recherche Translationnelle et Innovation en Médecine et Complexité - UMR 5525
24 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
Ambroise Montcriol
  • Function : Author
Vincent Cottenceau
  • Function : Author
Pierre Bouzat
  • Function : Author
Marie-Cecile Fevre
  • Function : Author
Clotilde Schilte
  • Function : Author
Olivier Vincent
  • Function : Author
Marie-Christine Hérault
  • Function : Author
Thomas Mistral
  • Function : Author
Thibaut Trouve-Buisson
  • Function : Author
Julien Picard
  • Function : Author
Dominique Falcon
  • Function : Author
Samuel Bersinger
  • Function : Author
Clément Mourey
  • Function : Author
Anaïs Adolle
  • Function : Author
Samia Salah
  • Function : Author
Pauline Manhes
  • Function : Author
Angélina Pollet
  • Function : Author
Frédéric Greco
  • Function : Author
Kevin Chalard
  • Function : Author
Bailleul Andréa
  • Function : Author
Lionel Velly
  • Function : Author
Nicolas Bruder
  • Function : Author
Imane Inal
  • Function : Author
Clément Magand
  • Function : Author
Laetitia Burnol
  • Function : Author
Anaèle Pregny
  • Function : Author
Jean-Christophe Ferre
  • Function : Author
Elise Bannier
  • Function : Author
Thomas Lebouvier
  • Function : Author
Sophie Caradec
  • Function : Author
Claire-Marie Drevet
  • Function : Author
Abdelouaid Nadji
  • Function : Author
Romain Lewandowski
  • Function : Author
Frédéric Dailler
  • Function : Author
Romain Carrillon
  • Function : Author
Florent Gobert
  • Function : Author
Thomas Ritzenthaler
  • Function : Author
Mathilde Leclercq
  • Function : Author
Nathalie Dumont
  • Function : Author
Claire Charpentier
  • Function : Author
Ionel Alb
  • Function : Author
Natalie de Sa
  • Function : Author
Nicolas Declerck
  • Function : Author
Pierre Boussemart
  • Function : Author
Julie Bellet
  • Function : Author
Eric Meaudre-Desgouttes
  • Function : Author
Erwan d'Aranda
  • Function : Author
Pierre Esnault
  • Function : Author
Camille Charruau
  • Function : Author
Rémy Bellier
  • Function : Author
Thierry Benard
  • Function : Author
Elsa Carise
  • Function : Author
Sabrina Seguin
  • Function : Author
Jean Yves Lefrant
  • Function : Author
Aurélien Daurat
  • Function : Author
Audrey Ambert
  • Function : Author
Marie Lebouc
  • Function : Author
Serge Hautefeuille
  • Function : Author
Etienne Escudier
  • Function : Author
Fabrice Bing
  • Function : Author
Bernard Cosserant
  • Function : Author
Romain Grobost
  • Function : Author
Camille Boissy
  • Function : Author
Marc Begard
  • Function : Author
Adrien Guyot
  • Function : Author
Kevin Lagarde
  • Function : Author
Elodie Caumon
  • Function : Author
Thomas Geeraerts
Maxime Pommier
  • Function : Author
Edouard Naboulsi
  • Function : Author
Maxime Beilvert
  • Function : Author
Elodie Parry
  • Function : Author
Marc Leone
  • Function : Author
Laurent Zieleskiewicz
  • Function : Author
Gary Duclos
  • Function : Author
Charlotte Arbelot
  • Function : Author
Ichai Carole
  • Function : Author
Quintard Hervé
  • Function : Author
Diop Aminata
  • Function : Author
Louis Puybasset
  • Function : Author
Gregory Torkomian
  • Function : Author
Magdalena Szczot
  • Function : Author
Stephane Kremer
Guillaume Becker
  • Function : Author
Stephane Hecketsweiler
  • Function : Author
Dejan Ilic
  • Function : Author
Lucie Vettoretti
  • Function : Author
Coline Grisotto
  • Function : Author
Romain Asmolov
  • Function : Author
Vincent Ehinger
  • Function : Author
Nathalie Laquay
  • Function : Author
Virginie Chevallier
  • Function : Author
Zahra Mahlal
  • Function : Author
Sigismond Lasocki
  • Function : Author
Anne-Sylvie Scholastique
  • Function : Author
Thomas Gaillard
  • Function : Author
Soizic Gergaud
  • Function : Author
Emmanuel Barbier
  • Function : Author
Florence Tahon
  • Function : Author
Alexandre Krainik
  • Function : Author
Michel Dojat
  • Function : Author
Irène Tropres
  • Function : Author
Bernard Vigue
  • Function : Author
Laura Leo
  • Function : Author
Vincent Piriou
  • Function : Author
Antoine Coquerel
  • Function : Author
Jean-Luc Cracowski
  • Function : Author
Francois Proust
  • Function : Author
Michel Mallaret
  • Function : Author

Abstract

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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Dates and versions

hal-04475688 , version 1 (23-02-2024)

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Jean-François Payen, Yoann Launey, Russell Chabanne, Samuel Gay, Gilles Francony, et al.. 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. The Lancet Neurology, 2023, 22 (11), pp.1005-1014. ⟨10.1016/S1474-4422(23)00290-9⟩. ⟨hal-04475688⟩
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