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iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03257904
Acronym
SynapseICU
Enrollment
2395
Registered
2017-08-22
Start date
2018-03-15
Completion date
2020-06-11
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Traumatic Brain Injury

Keywords

intracranial pressure

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).

Interventions

measurement of intracranial pressure

Sponsors

European Society of Intensive Care Medicine
CollaboratorOTHER
University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \> 18 years; 2. Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury; 3. 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

1. Acute Brain Injury (ABI) who are not admitted to ICU; 2. ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Long-term outcome measures of neurological disability6 monthsExtended Glasgow Outcome Scale score

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026