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

What this Trial Is About

Researchers are studying intracranial pressure (ICP) monitoring in patients with acute brain injury, including hemorrhagic stroke and traumatic brain injury. This study evaluates a new Integra CereLink ICP monitor that continuously records and displays the Pressure Time Dose (PTD), which measures the area under the curve of ICP over time. The goal is to determine if continuous PTD monitoring relates to patient outcomes and to identify a PTD threshold that predicts changes from good to poor outcomes. The study is a prospective, observational international cohort involving centers already using the Integra CereLink ICP monitor. It collects data from patients receiving ICP monitoring as part of their clinical care, without affecting treatment decisions. The monitor provides high-resolution ICP data, including mean ICP and PTD values. Patients will be followed for mortality and functional outcomes measured by the Glasgow Outcome Scale Extended (GOSE) at ICU or hospital discharge and at 6 months. Participants' medical records and ICP data will be collected electronically and anonymized. Researchers will perform statistical analyses to explore associations between PTD and patient outcomes, comparing PTD with traditional hourly ICP measurements. Safety monitoring is observational, with no additional risks as no interventions are applied. The total participation includes data collection during ICU stay and follow-up at 6 months after injury.

Intracranial PrEssure Time dOse (ImPETO)