Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 12:57 PM
Study NCT ID:
NCT03257904
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Sponsor:
University of Milano Bicocca
Organization:
Study Overview
Official Title:
International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SynapseICU
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.
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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: