iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)

University of Milano Bicocca

Status: Completed

Conditions: Subarachnoid Hemorrhage; Traumatic Brain Injury; Intracerebral Hemorrhage

Treatments: Procedure: intracranial pressure monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03257904

SynapseICU

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.