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Posterior Fossa Intracranial Pressure (ICP) Measurement: Clinical Study - Trial NCT04675216

Access comprehensive clinical trial information for NCT04675216 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Valencia and is currently Recruiting. The study focuses on Intracranial Pressure Increase. Target enrollment is 12 participants.

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NCT04675216
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Trial Details
ClinicalTrials.gov โ€ข NCT04675216
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Posterior Fossa Intracranial Pressure (ICP) Measurement: Clinical Study
Posterior Fossa Intracranial Pressure (ICP) Measurement in Cases of Traumatic, Ischemic, or Tumor Pathology (Post-surgical) at This Level: Clinical Study

Study Focus

Posterior fossa intracranial pressure measurement

Observational

procedure

Sponsor & Location

University of Valencia

Valencia,Valencia, Spain

Timeline & Enrollment

N/A

Jul 19, 2019

Dec 31, 2022

12 participants

Primary Outcome

Posterior fossa intracranial pressure,Clinical status of patients

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.

ICD-10 Classifications

Benign intracranial hypertension
Intracranial injury
Intracranial injury, unspecified
Other intracranial injuries
Intracranial hypotension following ventricular shunting

Data Source

ClinicalTrials.gov

NCT04675216

Non-Device Trial