Clinical trial Recruiting at 2 sites Observational Ages 18 to 80

Measuring pressure in the back of the skull (posterior fossa ICP) after surgery

Official title: Posterior Fossa Intracranial Pressure (ICP) Measurement in Cases of Traumatic, Ischemic, or Tumor Pathology (Post-surgical) at This Level: Clinical Study

Run by University of Valencia · NCT04675216 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment12 (estimated)
SponsorUniversity of Valencia
Academic / other
Locations2 sites (Valencia, Valencia and 1 other locations)
StatusRecruiting
StartedJuly 19, 2019
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedApril 22, 2026
Trial IDNCT04675216 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Hospital General Universitario de Valencia
    Valencia, Valencia, Spain
    Recruiting
  • Vicente Vanaclocha
    Valencia, Valencia, Spain
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.