International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)

University of Milano Bicocca1 site in 1 country2,395 target enrollmentMarch 15, 2018

Overview

Brief Summary

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.

The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.

Detailed Description

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units. The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies. Sample Size: This international prospective observational study aims to recruit \>2000 patients in coma after acute traumatic and non-traumatic brain damage admitted to \>200 Intensive Care Units. Inclusion Criteria: * Acute brain injury (ABI) admitted to ICU following: 1. Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, 2. Traumatic brain injury (penetrating and non-penetrating). * Age \>18 years old * Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5 Exclusion Criteria: * ABI who are not admitted to ICU; * ABI due to infections of the central nervous system, ischemic stroke or other causes not defined in the inclusion criteria Outcome measures: Glasgow Outcome Score-Extended at 6 months Endpoint: The primary endpoint is the variation in clinical practice around ICP monitoring in acute brain injury patients. Screening and recruitment: 12 weeks at each centre, or the duration required to enrol 90 patients per centre. Follow-up: outcome measures will be collected at 6 months. Duration of study: 2 years. The SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).

Registry

clinicaltrials.gov

Start Date

March 15, 2018

End Date

June 11, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of Milano Bicocca

Responsible Party

Principal Investigator

Giuseppe Citerio, MD

Professor

University of Milano Bicocca

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years;
•Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
•Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

Exclusion Criteria

•Acute Brain Injury (ABI) who are not admitted to ICU;
•ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.