[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414330":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":62,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":79,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Valencia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Posterior fossa lesion",null,"This group will be integrated by patients with posterior fossa lesion that likely to rise the posterior fossa intracranial pressure",[13],"Procedure: Posterior fossa intracranial pressure measurement",{"label":15,"type":10,"description":16,"interventionNames":17},"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",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Posterior fossa intracranial pressure measurement","Measurement of posterior fossa pressure in an invasive way",[15,9],[25,49],{"facility":26,"status":27,"city":28,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Hospital General Universitario de Valencia","RECRUITING","Valencia","46014","Spain","ES",{"type":33,"coordinates":34},"Point",[35,36],-0.37966,39.47391,{"lat":36,"lon":35},[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Vicente Vanaclocha, MDPhD","CONTACT","+34 963 13 18 00","438500","vivava@uv.es; vvanaclo@hotmail.com",{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},"Teresa Moratal","437334","ceicvalencia_hgv@gva.es",{"facility":50,"status":27,"city":28,"state":28,"zip":51,"country":30,"countryCode":31,"cosmosGeoPoint":52,"geoPoint":54,"contacts":55},"Vicente Vanaclocha","46015",{"type":33,"coordinates":53},[35,36],{"lat":36,"lon":35},[56,60],{"name":57,"role":41,"phone":58,"phoneExt":10,"email":59},"Vicente Vanaclocha Vanaclocha, Prof MD PhD","669790013","vvanaclo@hotmail.com",{"name":61,"role":41,"phone":58,"phoneExt":10,"email":59},"Vicente Vanaclocha Vanaclocha",{"type":63,"investigatorFullName":50,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Associate Professor of Medicine","100414330","posterior-fossa-intracranial-pressure-icp-measurement-clinical-study-100414330",false,"NCT04675216","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","Postfossa ICP","Inclusion Criteria:\n\n* minimum age of 18 years\n* traumatic, tumor, ischemic, or hemorrhagic pathology of the posterior fossa\n* GCS of 8 or less.\n\nExclusion Criteria:\n\n* coagulation disorders\n* multi-organ failure\n* multiple pathologies\n* open head trauma to the posterior fossa with leakage of nervous tissue","ALL","18 Years","80 Years",{"count":77,"type":78},12,"ESTIMATED","2 Years","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.\n\nIt 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.\n\nCurrently, 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.\n\nMonitoring 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\u002Fmortality in this subgroup of patients.",[83],"Intracranial Pressure Increase",[85,86,87,88,89],"Intracranial pressure","Posterior fossa","Posterior fossa tumor","Cerebellar hematoma","Cerebellar infarct","2026-04-18",{"date":92,"type":93},"2026-04-22","ACTUAL",{"date":95,"type":93},"2019-07-19",{"date":97,"type":78},"2026-12",{"name":5,"class":6},2]