Monitoring intracranial pressure to assess patient outcomes
Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor
This study is testing if continuous monitoring of pressure inside the skull can help doctors understand how well patients with serious brain injuries are doing and predict their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT04459806 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the clinical utility of continuous intracranial pressure (ICP) monitoring using the Integra CereLink ICP monitor. It aims to determine if the Pressure Time Dose (PTD) metric, derived from continuous ICP recordings, correlates with patient outcomes in individuals with acute brain injuries. The study will identify a threshold of PTD that signifies a transition from favorable to unfavorable outcomes, thereby enhancing the understanding of ICP monitoring in neurocritical care. The research is grounded in existing guidelines and seeks to address gaps in current ICP monitoring practices.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 diagnosed with acute brain injuries such as hemorrhagic stroke or traumatic brain injury requiring ICP monitoring.
Not a fit: Patients who do not have an ICP monitor inserted or those not connected to the Integra CereLink ICP monitor will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve patient outcomes by establishing effective ICP monitoring thresholds for better management of acute brain injuries.
How similar studies have performed: While ICP monitoring is a common practice, this specific approach to evaluating PTD in non-traumatic brain injuries is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Monza, MB
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
Study contacts
- Principal investigator: Giuseppe Citerio, Professor — University of Milano Bicocca
- Study coordinator: Giuseppe Citerio, Professor
- Email: giuseppe.citerio@unimib.it
- Phone: +39039233
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.