Clinical Trial

Intracranial PrEssure Time dOse (ImPETO)

Study acronym: ImPETO
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-07-01; most recent amendment 2025-09-08.
Status change: Not Yet Recruiting → Recruiting 2023-11-30
Status change: Completed → Not Yet Recruiting 2023-11-03
Status change: Recruiting → Completed 2023-01-23
Status change: Not Yet Recruiting → Recruiting 2021-12-21
Trial Details
NCT Number NCT04459806
Lead Sponsor University of Milano Bicocca
Collaborators: Integra LifeSciences Corporation
Conditions Intracranial Hypertension, Traumatic Brain Injury, Subarachnoid Hemorrhage, Intracranial Hemorrhages
Enrollment 250 participants
Start Date 2023-11-13
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-15