RecruitingNCT04459806

Intracranial PrEssure Time dOse (ImPETO)

Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor


Sponsor

University of Milano Bicocca

Enrollment

250 participants

Start Date

Nov 13, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria2

  • ICP monitoring not inserted
  • No availability of the Integra CereLink ICP monitor.

Interventions

PROCEDUREintracranial pressure monitoring

Invasive monitoring of intracranial pressure by using CereLink monitor.


Locations(1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy

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NCT04459806


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