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
Introduction Intracranial 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 intracrani...
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/8/e040550.full |
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| author | Nicolas Bruder Thomas Geeraerts Jean Luc Bosson Claire Dahyot-fizelier Pierre Bouzat Jean-François Payen Laurent Gergelé Gérard Audibert Louis Puybasset Marion Richard Gilles Francony Emmanuel L Barbier Bernard Vigue Kristina Skaare |
| author_facet | Nicolas Bruder Thomas Geeraerts Jean Luc Bosson Claire Dahyot-fizelier Pierre Bouzat Jean-François Payen Laurent Gergelé Gérard Audibert Louis Puybasset Marion Richard Gilles Francony Emmanuel L Barbier Bernard Vigue Kristina Skaare |
| author_sort | Nicolas Bruder |
| collection | DOAJ |
| description | Introduction Intracranial 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 analysis Multicentre, 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 + PbtO2 group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO2 group 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 dissemination This 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 ClinTrials NCT02754063 on 28 April 2016 (pre-results). |
| format | Article |
| id | doaj-art-fc82c329cba14600ba824455890c1250 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-fc82c329cba14600ba824455890c12502024-12-02T01:25:09ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-040550Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocolNicolas Bruder0Thomas Geeraerts1Jean Luc Bosson2Claire Dahyot-fizelier3Pierre Bouzat4Jean-François Payen5Laurent Gergelé6Gérard Audibert7Louis Puybasset8Marion Richard9Gilles Francony10Emmanuel L Barbier11Bernard Vigue12Kristina Skaare13Department of Anaesthesiology and Intensive Care, Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, FranceDepartment of Anaesthesia and Intensive Care, Toulouse University Hospital and Toulouse 3-Paul Sabatier University, Toulouse, FranceTIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, FranceRéanimation Chirurgicale, CHRU de Poitiers, Poitiers, FranceDépartement dAnesthésie Réanimation, Centre Hospitalier Universitaire de Grenoble, Grenoble, FranceDepartment of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France5CHU de Saint Etienne, CREATIS, UMR CNRS 5220 INSERM U1040 INSA-Lyon, Université de Lyon, Lyon, FranceHôpital Central, Service d’Anesthésie-Réanimation, CHRU Nancy, Nancy, FranceDepartment of Anaesthesia and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, FranceDepartment of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, FranceDepartment of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, FranceDepartment of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, FranceDepartment of Anaesthesia and Intensive care, Centre Hospitalier Universitaire de Bicêtre, Assistance Publique - Hopitaux de Paris, Le Kremlin Bicêtre, FranceDepartment of Public Health, Univ. Grenoble Alpes, CHU Grenoble Alpes, Grenoble, FranceIntroduction Intracranial 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 analysis Multicentre, 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 + PbtO2 group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO2 group 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 dissemination This 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 ClinTrials NCT02754063 on 28 April 2016 (pre-results).https://bmjopen.bmj.com/content/10/8/e040550.full |
| spellingShingle | Nicolas Bruder Thomas Geeraerts Jean Luc Bosson Claire Dahyot-fizelier Pierre Bouzat Jean-François Payen Laurent Gergelé Gérard Audibert Louis Puybasset Marion Richard Gilles Francony Emmanuel L Barbier Bernard Vigue Kristina Skaare 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 BMJ Open |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/8/e040550.full |
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