Measuring pressure in the back of the skull (posterior fossa ICP) after surgery
Posterior Fossa Intracranial Pressure (ICP) Measurement in Cases of Traumatic, Ischemic, or Tumor Pathology (Post-surgical) at This Level: Clinical Study
We will try measuring intracranial pressure in the posterior fossa of adults with posterior fossa trauma, tumors, stroke, or bleeding who have low consciousness (GCS ≤8) to collect pressure values and compare them with standard frontal ICP readings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Valencia Academic / other |
| Locations | 2 sites (Valencia, Valencia and 1 other locations) |
| Trial ID | NCT04675216 on ClinicalTrials.gov |
What this trial studies
This observational study will place a posterior fossa ICP sensor in adults after posterior fossa surgery and record pressure values in the immediate postoperative period. The plan is to recruit about 12 patients with traumatic, tumor, ischemic, or hemorrhagic posterior fossa pathology and Glasgow Coma Scale ≤8. Frontal (supratentorial) ICP measurements will be recorded concurrently to compare the two locations. Data will be used to define a range of posterior fossa ICP values in physiological postoperative conditions and in pathological cases to determine whether frontal readings reliably reflect posterior fossa pressure.
Who should consider this trial
Good fit: Adults aged 18 or older who require posterior fossa surgery for traumatic, tumoral, ischemic, or hemorrhagic lesions and have a Glasgow Coma Scale of 8 or lower (with consent by proxy if needed) are the intended participants.
Not a fit: People without posterior fossa disease, those with GCS above 8, and patients excluded for coagulation disorders, multi-organ failure, or open posterior fossa trauma are unlikely to benefit from this monitoring approach.
Why it matters
Potential benefit: If successful, this could help clinicians detect dangerous pressure increases in the posterior fossa earlier and guide interventions that may prevent clinical deterioration or death.
How similar studies have performed: Small experimental and clinical series have suggested that supratentorial (frontal) ICP does not always reflect posterior fossa pressure, but published clinical evidence is limited and sample sizes have been small.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * minimum age of 18 years * traumatic, tumor, ischemic, or hemorrhagic pathology of the posterior fossa * GCS of 8 or less. Exclusion Criteria: * coagulation disorders * multi-organ failure * multiple pathologies * open head trauma to the posterior fossa with leakage of nervous tissue
Where this trial is running
Valencia, Valencia and 1 other locations
- Hospital General Universitario de Valencia — Valencia, Valencia, Spain (Recruiting)
- Vicente Vanaclocha — Valencia, Valencia, Spain (Recruiting)
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.