SYNAPSE-ICU (Scotland)
Research type
Research Study
Full title
International prospective observational StudY on iNtrAcranial PreSsurE in intensive care (ICU): The SYNAPSE-ICU Study
IRAS ID
257916
Contact name
Lara Prisco
Contact email
Sponsor organisation
University Milano Bicocca & Hospital San Gerardo - Monza
Clinicaltrials.gov Identifier
NCT03257904, clinical trials.gov registration
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Acute brain damage following trauma or cerebrovascular accidents such as spontaneous intracerebral haemorrhage and aneurysmal subarachnoid haemorrhage carry the risk of a life-threatening condition called ‘intracranial hypertension’.
Due to the rigidity of the skull, an increase in size of its contents (1. brain, due to brain swelling; 2. Blood, due to large clots; 3. cerebrospinal fluid due to obstruction of the normal flow pathways) leads to compression of vital structures of the brain itself that control the level of consciousness, breathing and heart function amongst others.
To prevent this condition, clinicians monitor the pressure within the skull with a probe inserted via a small hole drilled in the bone: this is called Intracranial Pressure Monitoring (ICPm). Most of the intensive care units around the world have adopted a standardised protocol with a stepwise treatment algorithm for treatment of intracranial hypertension.
Despite guidelines and recommendations, there remains a large variation in the indication for ICPm insertion and management of raised intracranial pressure. This is due to local policies, resources and culture. However, a precise picture of this variation remains unexplored.
This study aims to collect anonymised data to explore the variation in practice of ICPm use and the variation in the management of intracranial hypertension in patients with traumatic brain injury, intracerebral haemorrhage and subarachnoid haemorrhage admitted to Intensive Care Units.
To obtain a complete assessment of the practice of ICPm use and treatment of intracranial hypertension, the study aims to recruit a large population (5000 patients) from high-, middle- and low-income countries.
This study is observational, hence patients will only receive treatment usually delivered on that intensive care unit. No additional procedures or interventions will be carried as part of the study so there are no immediate risks posed to recruited participants.REC name
Scotland A: Adults with Incapacity only
REC reference
19/SS/0004
Date of REC Opinion
24 Jan 2019
REC opinion
Favourable Opinion