Actively Recruiting

Age: 18Years - 80Years
All Genders
ID04675216

Posterior Fossa Intracranial Pressure Measurement in Traumatic, Ischemic, or Tumor Pathology (Post-Surgical) Clinical Study

Led by University of Valencia · Updated on 2026-04-22

12

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the measurement of intracranial pressure (ICP) specifically in the posterior fossa region of the brain in patients with traumatic, tumor, ischemic, or hemorrhagic conditions. The study aims to establish normal and pathological ranges of posterior fossa ICP and compare these values to the standard supratentorial ICP measurements. This information is important as posterior fossa ICP changes can directly impact clinical outcomes and inform medical or surgical treatment decisions in these brain conditions. The study involves monitoring ICP invasively in the posterior fossa postoperatively in 12 patients who have undergone surgery for posterior fossa pathologies. Two sensors will be inserted: one at the supratentorial (frontal) level and another in the posterior fossa (infratentorial) to continuously record pressure readings. The study will analyze the correlation between these two ICP measurements and assess safety, potential complications, and the impact of ICP on clinical status and treatment choices. Participants will be closely monitored with continuous ICP data collection and their clinical status evaluated for one month. Researchers will analyze the relationship between ICP values and patient outcomes, investigating any complications from sensor placement. The study's primary measures include posterior fossa ICP levels and clinical status over the one-month period. This research aims to improve monitoring and treatment decisions for patients with posterior fossa brain conditions.

CONDITIONS

Brief Title

Posterior Fossa Intracranial Pressure (ICP) Measurement: Clinical Study

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Minimum age of 18 years
  • Traumatic, tumor, ischemic, or hemorrhagic pathology of the posterior fossa
  • Glasgow Coma Scale (GCS) score of 8 or lower
Not Eligible

You will not qualify if you...

  • Blood clotting (coagulation) disorders
  • Multi-organ failure
  • Multiple serious health conditions
  • Open head trauma to the posterior fossa with leakage of nervous tissue

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 1 month

Participants have intracranial pressure sensors placed in the posterior fossa and supratentorial areas after surgery to continuously record pressure data.

Continuous monitoring during hospital stay with data recorded on a computer

Follow-up

Duration - Up to 1 month

Participants are observed for clinical status and any complications related to intracranial pressure sensor placement after monitoring ends.

1 to 2 follow-up visits depending on clinical status

Trial Site Locations

Total: 2 locations

1

Hospital General Universitario de Valencia

Valencia, Valencia, Spain, 46014

Actively Recruiting

2

Vicente Vanaclocha

Valencia, Valencia, Spain, 46015

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

[Monitoring of intracranial pressure difference between supra- and infratentorial spaces after posterior fossa tumor removal (case report)].

A V Oshorov, I A Savin, A S Goriachev...

https://pubmed.ncbi.nlm.nih.gov/21957628

Is it useful to measure supratentorial ICP in the presence of a posterior fossa lesion? Absence of transtentorial pressure gradients in an animal model.

A Rieger, N G Rainov, L Sanchin...

https://pubmed.ncbi.nlm.nih.gov/10627774