Intracranial PrEssure Time dOse (ImPETO)
Recruiting · NCT04459806 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Milano Bicocca
View the official record on ClinicalTrials.gov →Interventions studied
intracranial pressure monitoring
What this trial is about
The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting. Therefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Aged within 18 and 80 years;
- Diagnosed of an acute brain injury (ABI) for hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury;
- ICP monitoring started for clinical indication and accordingly to local policies
- ICP device connected to the Integra CereLink ICP monitor.
Exclusion criteria
- ICP monitoring not inserted
- No availability of the Integra CereLink ICP monitor.
Where it is running
1 location listed.
- Fondazione IRCCS San Gerardo dei Tintori - Monza, MB, Italy