Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): a multicentre, randomised, blinded-endpoint, comparative effectiveness study of brain tissue oxygen and intracranial pressure monitoring versus intracranial pressure alone

Francis Bernard, William Barsan, Ramon Diaz-Arrastia, Lisa H Merck, Sharon Yeatts, Lori A Shutter, Francis Bernard, William Barsan, Ramon Diaz-Arrastia, Lisa H Merck, Sharon Yeatts, Lori A Shutter

Abstract

Introduction: Management of traumatic brain injury (TBI) includes invasive monitoring to prevent secondary brain injuries. Intracranial pressure (ICP) monitor is the main measurement used to that intent but cerebral hypoxia can occur despite normal ICP. This study will assess whether the addition of a brain tissue oxygenation (PbtO2) monitor prevents more secondary injuries that will translate into improved functional outcome.

Methods and analysis: Multicentre, randomised, blinded-endpoint comparative effectiveness study enrolling 1094 patients with severe TBI monitored with both ICP and PbtO2. Patients will be randomised to medical management guided by ICP alone (treating team blinded to PbtO2 values) or both ICP and PbtO2. Management is protocolised according to international guidelines in a tiered approach fashion to maintain ICP <22 mm Hg and PbtO2 >20 mm Hg. ICP and PbtO2 will be continuously recorded for a minimum of 5 days. The primary outcome measure is the Glasgow Outcome Scale-Extended performed at 180 (±30) days by a blinded central examiner. Favourable outcome is defined according to a sliding dichotomy where the definition of favourable outcome varies according to baseline severity. Severity will be defined according to the probability of poor outcome predicted by the IMPACT core model. A large battery of secondary outcomes including granular neuropsychological and quality of life measures will be performed.

Ethics and dissemination: This has been approved by Advarra Ethics Committee (Pro00030585). Results will be presented at scientific meetings and published in peer-reviewed publications.

Trial registration number: ClinicalTrials.gov Registry (NCT03754114).

Keywords: adult intensive & critical care; neurological injury; neurophysiology; neurosurgery; protocols & guidelines; trauma management.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Randomisation, inclusion and exclusion criteria. EFIC, exception from informed consent; FiO2, fractional inspired oxygen; ICP, intracranial pressure; PaO2, arterial oxygen pressure; PbtO2, brain tissue oxygenation; SaO2, arterial oxygen saturation; SBP, systolic blood pressure; TBI, traumatic brain injury
Figure 2
Figure 2
Four possible clinical scenarios based on monitoring information. ICP, intracranial pressure; PbtO2, brain tissue oxygenation.
Figure 3
Figure 3
Outcome defined according to sliding dichotomy.

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