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SYNAPSE-ICU –  An international prospective observational StudY on iNtrAcranial PreSsurE in intensive care (ICU)

What?

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

This project, initiated by the ESICM NIC Section is an international prospective observational study that will be conducted in several ICUs in different countries.

Why?

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

How? 

Methods

Sample Size: This international prospective observational study aims to recruit >5000 patients in coma after acute traumatic and non-traumatic brain damage admitted to >500 Intensive Care Units.

Inclusion Criteria:

  • Admission to ICU following acute brain injury (ABI) in:
    • Haemorrhagic stroke, including:
      • intracerebral haematoma
      • subarachnoid haemorrhage;
    • Traumatic brain injury (penetrating and non-penetrating).
  • Age >18 years old.
  • Eye Opening of the Glasgow Coma Scale = 1 on admission to ICU or neuroworsening with no Eye opening in the first 48 hrs.
  • Motor score of the Glasgow Coma Scale on admission to ICU <6 or neuroworsening with motor score decreased to <6 in the first 48 hrs.

Exclusion Criteria:

  • Acute brain injury (ABI) not admitted to ICU.
  • Other ABI (infective CSN disorders, ischemic stroke) not included in the inclusion criteria.
  • Age < 18 years old.
  • Eye opening on admission > 1 or Motor score of the Glasgow Coma Scale on admission to ICU = 6 without neuroworsening in the following 48 hours.

Outcome measures: Glasgow Outcome Scale-Extended at 3-6 months

Endpoint: The primary endpoint of the study is the exploration of the effect size of the variation in clinical practice around ICP monitoring in acute brain injury patients.

Duration of study

Screening and recruitment: 12 weeks at each centre.
Follow-up: outcome measures will be collected at 3-6 months.

Do I need IRB approval?

Centres prepared to participate must obtain approval of the local ethics committee or review board.

Is there any financial compensation?

No. Participation in the trial is completely voluntary.

How do I participate?

Register your interest here.

If you are interested in becoming a National Representative (NR), you can select an option during your registration of interest (check our current NR list). An NR arranges the ethics committee or IRB approval on national level and is the main contact for local investigators regarding ethical queries. The NR is requested to promote the trial at a national level using his network (example of promotional material).

Financial support

The project received a €50,000 grant from ESICM after inclusion in the Trial Group portfolio.

Principal Investigator

Giuseppe CITERIO  University Milano Bicocca & Hospital San Gerardo, Monza,(Italy)

Documents

Media

In this comprehensive icTV interview, Giuseppe Citerio and Lara Prisco discuss the questions that the SYNAPSE-ICU study hopes to answer, which centres they are seeking to join and the timeline for this important ESICM Trials Group project.

For more information, please contact: research@esicm.org

Follow us on Twitter: @SYNAPSE_ICU