International prospective observational study on intracranial pressure in intensive care (ICU): the SYNAPSE-ICU study protocol.

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State: Public
Version: Final published version
License: CC BY-NC 4.0
Serval ID
serval:BIB_4BABE4E87F74
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
International prospective observational study on intracranial pressure in intensive care (ICU): the SYNAPSE-ICU study protocol.
Journal
BMJ open
Author(s)
Citerio G., Prisco L., Oddo M., Meyfroidt G., Helbok R., Stocchetti N., Taccone F., Vincent J.L., Robba C., Elli F., Sala E., Vargiolu A., Lingsma H.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
20/04/2019
Peer-reviewed
Oui
Volume
9
Number
4
Pages
e026552
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
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.
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.
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.
NCT03257904.
Keywords
Brain Injuries/physiopathology, Critical Care/methods, Humans, Intensive Care Units, Internationality, Intracranial Pressure, Neurophysiological Monitoring, Observational Studies as Topic/methods, Practice Patterns, Physicians', Prospective Studies, Research Design, acute brain injury, intracranial pressure monitoring, traumatic brain injury
Pubmed
Web of science
Open Access
Yes
Create date
03/05/2019 17:51
Last modification date
27/04/2020 6:20
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