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

Plain Language Summary

Simplified for easier understanding

This study is collecting data on brain pressure (intracranial pressure, or ICP) in patients with acute brain injuries — such as a brain bleed or traumatic brain injury — to better understand how pressure patterns over time affect patient outcomes. **You may be eligible if:** - You are between 18 and 80 years old - You have been admitted with an acute brain injury, such as a brain bleed (hemorrhagic stroke) or traumatic brain injury (TBI) - Your doctors have already placed a brain pressure monitoring device as part of your standard care - Your brain pressure monitor is connected to a specific type of monitor (Integra CereLink ICP monitor) **You may NOT be eligible if:** - You do not have a brain pressure monitoring device in place - The specific Integra CereLink ICP monitor is not available at your care location Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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