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.
Journal
The Lancet. Neurology
ISSN: 1474-4465
Titre abrégé: Lancet Neurol
Pays: England
ID NLM: 101139309
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
received:
26
05
2023
revised:
21
07
2023
accepted:
26
07
2023
medline:
1
11
2023
pubmed:
21
10
2023
entrez:
20
10
2023
Statut:
ppublish
Résumé
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 (PbtO 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 PbtO 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 PbtO After severe non-penetrating traumatic brain injury, intracranial pressure and PbtO The French National Program for Clinical Research, La Fondation des Gueules Cassées, and Integra Lifesciences.
Sections du résumé
BACKGROUND
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 (PbtO
METHODS
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 PbtO
FINDINGS
RESULTS
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 PbtO
INTERPRETATION
CONCLUSIONS
After severe non-penetrating traumatic brain injury, intracranial pressure and PbtO
FUNDING
BACKGROUND
The French National Program for Clinical Research, La Fondation des Gueules Cassées, and Integra Lifesciences.
Identifiants
pubmed: 37863590
pii: S1474-4422(23)00290-9
doi: 10.1016/S1474-4422(23)00290-9
pii:
doi:
Substances chimiques
Oxygen
S88TT14065
Banques de données
ClinicalTrials.gov
['NCT02754063']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1005-1014Investigateurs
Marie-Cecile Fevre
(MC)
Clotilde Schilte
(C)
Olivier Vincent
(O)
Marie-Christine Hérault
(MC)
Thomas Mistral
(T)
Thibaut Trouve-Buisson
(T)
Julien Picard
(J)
Dominique Falcon
(D)
Samuel Bersinger
(S)
Clément Mourey
(C)
Anaïs Adolle
(A)
Samia Salah
(S)
Pauline Manhes
(P)
Angélina Pollet
(A)
Frédéric Greco
(F)
Kevin Chalard
(K)
Bailleul Andréa
(B)
Lionel Velly
(L)
Nicolas Bruder
(N)
Imane Inal
(I)
Clément Magand
(C)
Laetitia Burnol
(L)
Jérôme Morel
(J)
Anaèle Pregny
(A)
Jean-Christophe Ferre
(JC)
Elise Bannier
(E)
Thomas Lebouvier
(T)
Sophie Caradec
(S)
Claire-Marie Drevet
(CM)
Abdelouaid Nadji
(A)
Romain Lewandowski
(R)
Frédéric Dailler
(F)
Romain Carrillon
(R)
Florent Gobert
(F)
Thomas Ritzenthaler
(T)
Mathilde Leclercq
(M)
Nathalie Dumont
(N)
Claire Charpentier
(C)
Ionel Alb
(I)
Natalie De Sa
(N)
Nicolas Declerck
(N)
Pierre Boussemart
(P)
Julie Bellet
(J)
Eric Meaudre-Desgouttes
(E)
Erwan D'Aranda
(E)
Pierre Esnault
(P)
Camille Charruau
(C)
Rémy Bellier
(R)
Thierry Benard
(T)
Elsa Carise
(E)
Sabrina Seguin
(S)
Jean Yves Lefrant
(JY)
Aurélien Daurat
(A)
Audrey Ambert
(A)
Marie Lebouc
(M)
Serge Hautefeuille
(S)
Etienne Escudier
(E)
Fabrice Bing
(F)
Bernard Cosserant
(B)
Romain Grobost
(R)
Camille Boissy
(C)
Marc Begard
(M)
Adrien Guyot
(A)
Kevin Lagarde
(K)
Elodie Caumon
(E)
Thomas Geeraerts
(T)
Maxime Pommier
(M)
Edouard Naboulsi
(E)
Maxime Beilvert
(M)
Elodie Parry
(E)
Marc Leone
(M)
Laurent Zieleskiewicz
(L)
Gary Duclos
(G)
Charlotte Arbelot
(C)
Ichai Carole
(I)
Quintard Hervé
(Q)
Diop Aminata
(D)
Louis Puybasset
(L)
Gregory Torkomian
(G)
Magdalena Szczot
(M)
Stephane Kremer
(S)
Guillaume Becker
(G)
Stephane Hecketsweiler
(S)
Dejan Ilic
(D)
Lucie Vettoretti
(L)
Coline Grisotto
(C)
Romain Asmolov
(R)
Vincent Ehinger
(V)
Nathalie Laquay
(N)
Virginie Chevallier
(V)
Zahra Mahlal
(Z)
Sigismond Lasocki
(S)
Anne-Sylvie Scholastique
(AS)
Thomas Gaillard
(T)
Soizic Gergaud
(S)
Emmanuel Barbier
(E)
Florence Tahon
(F)
Alexandre Krainik
(A)
Michel Dojat
(M)
Irène Tropres
(I)
Bernard Vigue
(B)
Laura Leo
(L)
Vincent Piriou
(V)
Antoine Coquerel
(A)
Jean-Luc Cracowski
(JL)
Francois Proust
(F)
Michel Mallaret
(M)
Informations de copyright
Copyright © 2023 Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of interests J-FP reports honoraria from Integra Lifesciences, Sedana Medical, and IDD CDM-Lavoisier. PB and TG report honoraria from Laboratoire du Biomédicament Français. RC reports consulting fees from Roche Diagnostics and Sophysa, and receives support for attending meetings from UCB. LG reports grants from La Fondation des Gueules Cassées, Ramsay Santé, and Sophysa; consulting fees from Sophysa; honoraria for lectures from Sophysa and Fresenius; support for attending meeting from Pfizer and Sophysa; and receipt of equipment from Atys Medical. All other authors declare no competing interests.