Article Text
Abstract
Introduction Intracranial pressure (ICP) monitoring is commonly used in neurocritical care patients with acute brain injury (ABI). Practice about indications and use of ICP monitoring in patients with ABI remains, however, highly variable in high-income countries, while data on ICP monitoring in low and middle-income countries are scarce or inconsistent. The aim of the SYNAPSE-ICU study is to describe current practices of ICP monitoring using a worldwide sample and to quantify practice variations in ICP monitoring and management in neurocritical care ABI patients.
Methods and analysis The SYNAPSE-ICU study is a large international, prospective, observational cohort study. From March 2018 to March 2019, all patients fulfilling the following inclusion criteria will be recruited: age >18 years; diagnosis of ABI due to primary haemorrhagic stroke (subarachnoid haemorrhage or intracranial haemorrhage) or traumatic brain injury; Glasgow Coma Score (GCS) with no eye opening (Eyes response=1) and Motor score ≤5 (not following commands) at ICU admission, or neuro-worsening within the first 48 hours with no eye opening and a Motor score decreased to ≤5. Data related to clinical examination (GCS, pupil size and reactivity, Richmond Agitation-Sedation Scale score, neuroimaging) and to ICP interventions (Therapy Intensity Levels) will be recorded on admission, and at day 1, 3 and 7. The Glasgow Outcome Scale Extended (GOSE) will be collected at discharge from ICU and from hospital and at 6-month follow-up. The impact of ICP monitoring and ICP-driven therapy on GOSE will be analysed at both patient and ICU level.
Ethics and dissemination The study has been approved by the Ethics Committee ‘Brianza’ at the Azienda Socio Sanitaria Territoriale (ASST)-Monza (approval date: 21 November 2017). Each National Coordinator will notify the relevant ethics committee, in compliance with the local legislation and rules. Data will be made available to the scientific community by means of abstracts submitted to the European Society of Intensive Care Medicine annual conference and by scientific reports and original articles submitted to peer-reviewed journals.
Trial registration number NCT03257904.
- intracranial pressure monitoring
- acute brain injury
- traumatic brain injury
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Footnotes
Contributors CG designed the study (Principal Investigator), designed of the study, drafted the manuscript; CG, PL, OM, GM, HR, SN, TFS, JLV, EF, SE, RC, VA, HL critically revised the work for important intellectual content; HL and CG are responsible for the statistical and methodological aspects of the study. All authors read and approved the final manuscript and agree to be accountable for all aspects of the work.
Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. However, the SYNAPSE-ICU study has been endorsed by the European Society of Intensive Care Medicine (ESICM) on 31 January, 2017, and has been included in the ESICM Trials Group Portfolio on 11 August, 2017. Prof. Giuseppe Citerio won an ESICM Trial Group Award in 2017 for this project.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The SYNAPSE-ICU Steering Committee (SC) will consider any request on data sharing, and decisions will be made in relation to these requests by the Principal Investigator (GC) after the first multi-centre manuscript has been published. Data will be made available to ESICM members and to the scientific community by means of abstract submitted to the ESICM annual conference and by scientific reports and original articles submitted to peer-reviewed journals.
Patient consent for publication Not required.