ImPETO. - Intracranial PrEssure Time dOse
Research type
Research Study
Full title
Evaluation of Intracranial Pressure Time Dose By The Integra Cerelink ICP Monitor
IRAS ID
285868
Contact name
Jonathan KJ Rhodes
Contact email
Sponsor organisation
University of Milano-Bicocca
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 5 days
Research summary
Traumatic injury to the brain, in addition to initial damage caused, risks secondary further injury. Brain swelling and expansion is limited within the closed skull box. We measure the pressure within the skull, intracranial pressure (ICP), the most used direct neuromonitoring in critical care. There is evidence that both extent of primary and secondary injury and related scope for patient recovery, can be limited by providing the brain with ideal physiological conditions but how to monitor this remains uncertain.
Although ICP monitoring has some establishment in traumatic brain injury it is less clear when else to use it, e.g. after a non-traumatic bleed. ICP value is typically documented with other observations intermittently. ICP threshold and threshold-based treatment is used. The European Society of Intensive Care and Neurocritical Care Society consensus is that ICP (and from this a better estimate of the effective blood supply pressure to the brain; the perfusion pressure) should inform protocolised care and the most recent Brain Trauma Foundation guidelines agree based on moderate evidence.
We don't know if total duration (dose) of ICP, or periodic recorded spikes in pressure matter most. Continuous computerised recording and analysis is possible, it is in fact already taken from the patient monitor; unused or unprocessed.
This study aims to identify if display of the ICP dose continuously at the bedside (previously only studied retrospectively), can enable assessment of the clinical value of real-time Pressure Time Dose (PTD) computation in a standardized way. We aim to test clinically if PTD recorded continuously is associated with patients’ outcome and we aim to identify a threshold of PTD associated with the transition from good to poor outcomes. We will collect information on in-hospital mortality, Glasgow Outcome Scale extended at hospital discharge and 6 months and the pressure time dose mmHg/hour, mmHg/day, mmHg/week.
REC name
Wales REC 6
REC reference
22/WA/0016
Date of REC Opinion
15 Feb 2022
REC opinion
Further Information Favourable Opinion