International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milano Bicocca
- Enrollment
- 2,395
- Locations
- 1
- Primary Endpoint
- Long-term outcome measures of neurological disability
Study 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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Long-term outcome measures of neurological disability
Time Frame: 6 months
Extended Glasgow Outcome Scale score
Secondary Outcomes
No secondary outcomes reported
Investigators
Giuseppe Citerio, MD
Professor
University of Milano Bicocca