Posterior Fossa Intracranial Pressure (ICP) Measurement: Clinical Study

NCT04675216 | Recruiting

• 1 other identifier: 19/07/2017
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

In modern medicine, doctors attempt to monitor all physiological variables to assess their evolution and to decide, based on their changes, the therapeutic attitudes to adopt. Furthermore, this helps to establish a forecast of the evolution to be expected. The measurement of Intracranial Pressure (ICP) has become indispensable for managing brain pathology at the anterior and middle fossa level. Doctors generally carry out this measurement at the frontal level. However, experimental and clinical studies have shown that supra-tentorial ICP measurement does not precisely predict the ICP situation in the posterior fossa. The increased ICP in the posterior fossa is directly responsible for the clinical deterioration and eventual death in patients with tumour, hemorrhagic, or ischemic pathology of the posterior fossa structures. Some of these lesions are treatable, and their effects reversible if the increase in ICP in the posterior fossa is controlled by pharmacological or even surgical means, preventing it from reaching high levels. This need for on-time ICP control is genuine in the cerebellar hemispheres' lesions, not so much in lesions involving the brainstem. Therefore, the increase in ICP in the posterior fossa needs to be known and documented to facilitate decision-making regarding the therapy to be adopted, be it medical or surgical. It is known what the abnormal ICP levels are at the supratentorial level, but what is not known whether these same levels apply to the posterior fossa. In other words, what it is not know with certainty is whether the same levels of ICP in the posterior fossa and its elevation during the same time are going to have equally pernicious effects or these effects are greater or lesser. Doctors need to have tables of ICP values in the posterior fossa to help them decide when these values are in the physiological range. When posterior fossa intracranial pressure lye in the pathological range, and patients need pharmacological treatment or surgical decompression, knowing for sure the posterior fossa ICP is essential. Finally, when doctors also need to know when any therapeutic attempt is useless. Currently, doctors only monitor the ICP at the supra-tentorial level and deduce the changes in the posterior fossa from the CT and MRI images, that is, the size of the lesions, the occlusion of the cisterns, the internal cerebral hernias (cerebellar tonsils, trans-tentorial hernia from bottom to top). However, doctors do not have a tool that can objectify the pathophysiological situation of the posterior fossa's structures in real-time. Monitoring the posterior fossa ICP will help doctors in decision-making in patients with traumatic, hemorrhagic, ischemic, or tumour pathologies (in the latter case, in the postoperative period of posterior fossa tumours). This posterior fossa ICP measurement will lead to improvements in morbidity/mortality in this subgroup of patients.

Conditions

Intracranial Pressure Increase

Keywords

Intracranial pressure; Posterior fossa; Posterior fossa tumor; Cerebellar hematoma; Cerebellar infarct

Outcome Measures

Primary Outcomes (2)

• Posterior fossa intracranial pressure

  We will measure the posterior fossa intracranial pressure inserting a ICP sensor at the frontal area and another at the posterior fossa 2cm behind and at the level of the tip of mastoid process. The ICP values will be measured while patients are in ICU and for 2 days once back in the neurosurgical ward

  1 month

• Clinical status of patients

  We will correlate the clinical status of each patient with his/her posterior fossa intracranial pressure. The clinical status will include the Glasgow Coma Scale and the Glasgow Coma Score

  1 month

Study Arms (2)

Posterior fossa lesion

This group will be integrated by patients with posterior fossa lesion that likely to rise the posterior fossa intracranial pressure

Procedure: Posterior fossa intracranial pressure measurement

Post-operative posterior fosa surgical patients

This group will be integrated by patients operated for posterior fossa lesions in which we will try to find out what range of posterior fossa pressure is to be expected in this situation

Procedure: Posterior fossa intracranial pressure measurement

Interventions

Posterior fossa intracranial pressure measurement PROCEDURE

Measurement of posterior fossa pressure in an invasive way

Post-operative posterior fosa surgical patients; Posterior fossa lesion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with posterior fossa lesions, traumatic, neoplastic, ischemic, or hemorrhagic

You may qualify if:

• minimum age of 18 years
• traumatic, tumor, ischemic, or hemorrhagic pathology of the posterior fossa
• GCS of 8 or less.

You may not qualify if:

• coagulation disorders
• multi-organ failure
• multiple pathologies
• open head trauma to the posterior fossa with leakage of nervous tissue

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (2)

Hospital General Universitario de Valencia

Valencia, Valencia, 46014, Spain

RECRUITING

Vicente Vanaclocha

Valencia, Valencia, 46015, Spain

RECRUITING

Related Publications (8)

• Mizunari T. [Clinical aspects and intracranial pressure monitoring in cases of traumatic posterior fossa hematoma]. Nihon Ika Daigaku Zasshi. 1990 Aug;57(4):334-43. doi: 10.1272/jnms1923.57.334. Japanese.

  PMID: 2229331 RESULT

• Oshorov AV, Savin IA, Goriachev AS, Popugaev KA, Lubnin AIu. [Monitoring of intracranial pressure difference between supra- and infratentorial spaces after posterior fossa tumor removal (case report)]. Anesteziol Reanimatol. 2011 Jul-Aug;(4):74-7. Russian.

  PMID: 21957628 RESULT

• Rosenwasser RH, Kleiner LI, Krzeminski JP, Buchheit WA. Intracranial pressure monitoring in the posterior fossa: a preliminary report. J Neurosurg. 1989 Oct;71(4):503-5. doi: 10.3171/jns.1989.71.4.0503.

  PMID: 2795169 RESULT

• Rieger A, Rainov NG, Sanchin L, Ebel H, Furka I, Gorombey Z, Burkert W. Is it useful to measure supratentorial ICP in the presence of a posterior fossa lesion? Absence of transtentorial pressure gradients in an animal model. Br J Neurosurg. 1999 Oct;13(5):454-8.

  PMID: 10627774 RESULT

• Rooker S, De Visscher G, Van Deuren B, Borgers M, Jorens PG, Reneman RS, van Rossem K, Verlooy J. Comparison of intracranial pressure measured in the cerebral cortex and the cerebellum of the rat. J Neurosci Methods. 2002 Sep 15;119(1):83-8. doi: 10.1016/s0165-0270(02)00183-8.

  PMID: 12234639 RESULT

• Park CK. Accuracy of ICP monitoring in posterior fossa lesions. J Neurosurg. 1990 May;72(5):832-3. No abstract available.

  PMID: 2324809 RESULT

• Slavin KV, Misra M. Infratentorial intracranial pressure monitoring in neurosurgical intensive care unit. Neurol Res. 2003 Dec;25(8):880-4. doi: 10.1179/016164103771954014.

  PMID: 14669535 RESULT

• Wolfla CE, Luerssen TG, Bowman RM, Putty TK. Brain tissue pressure gradients created by expanding frontal epidural mass lesion. J Neurosurg. 1996 Apr;84(4):642-7. doi: 10.3171/jns.1996.84.4.0642.

  PMID: 8613857 RESULT

MeSH Terms

Conditions

Intracranial Hypertension; Infratentorial Neoplasms

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: July 19, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)