[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-hypertension":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,51,83,110,135,161,195,219,247,265,288],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100639121","strategies-for-weaning-from-external-ventricular-drainage-100639121",false,"NCT07630051","Strategies for Weaning From External Ventricular Drainage","SEVDVE2","Inclusion Criteria:\n\n* Adult patient (≥18 years)\n* Admitted to critical care for non-traumatic subarachnoid hemorrhage for less than 3 days\n* First external ventricular drain inserted within the last 3 days for hydrocephalus and\u002For intracranial hypertension\n* Patient consent, or consent from a relative, or inclusion under emergency inclusion procedure\n* Patient affiliated to or beneficiary of a social security scheme\n\nExclusion Criteria:\n\n* Moribund patient or patient with established treatment limitation\u002Fwithdrawal decisions\n* Patient with a pre-existing ventriculoperitoneal or ventriculoatrial shunt\n* Patient with chronic hydrocephalus\n* Pregnant, lactating, or parturient woman\n* Person deprived of liberty by judicial or administrative decision\n* Person under involuntary psychiatric care\n* Person under a legal protection measure\n* Concurrent participation in another study involving external ventricular drainage management","ALL","18 Years",{"count":19,"type":20},170,"ESTIMATED","INTERVENTIONAL",[23],"NA","External ventricular drainage is frequently used in neurocritical care, particularly in patients admitted for non-traumatic subarachnoid hemorrhage who develop hydrocephalus and\u002For intracranial hypertension. While external ventricular drainage is often initially lifesaving, its prolonged maintenance is associated with complications, especially infections and prolonged hospital length of stay. There is currently no consensus on the optimal weaning strategy. Two approaches are used in routine practice: direct clamping (the external ventricular drain is closed as soon as weanability criteria are met) and gradual weaning (the external ventricular drain level is progressively raised before final clamping). No randomized controlled trial has yet demonstrated the superiority of one strategy over the other in patients with non-traumatic subarachnoid hemorrhage.\n\nThe investigators hypothesize that a direct clamping strategy, combined with daily screening of standardized weanability criteria, will reduce the duration of external ventricular drain maintenance compared with the conventional gradual weaning strategy. SEVDVE-2 is a multicenter, randomized, controlled, parallel-group, single-blind superiority trial that will compare these two weaning strategies in 170 adult patients admitted to critical care for non-traumatic subarachnoid hemorrhage with a first external ventricular drain inserted within the previous 3 days. Patients will be randomized 1:1, stratified on the presence of an intraventricular hematoma. The primary outcome is the number of external ventricular drain-free days alive at Day 28.",[26,27,28,29],"Subarachnoid Hemorrhage","Hydrocephalus","Intracranial Hypertension","External Ventricular Drainage",[31,26,32,33,34,35,36,37],"External Ventricular Drain","Weaning; Hydrocephalus","Intracranial Pressure","Neurocritical Care","Direct Clamping","Gradual Weaning","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-01",{"date":41,"type":42},"2026-06-05","ACTUAL",{"date":44,"type":20},"2026-07-01",{"date":46,"type":20},"2031-10-01",{"name":48,"class":49},"University Hospital, Angers","OTHER_GOV",5,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100507612","external-lumbar-drainage-to-reduce-icp-in-severe-tbi-a-phase-1-clinical-trial-100507612","NCT05889650","External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial","External Lumbar Drainage to Abort Severe Traumatic IntraCranial Hypertension: A Phase 1 Randomized, Allocation-concealed, Open-label, Safety and Feasibility Clinical Trial","ELASTIC","Inclusion Criteria:\n\n1. 18-65 years age\n2. Glasgow Coma Scale (GCS) 3-8\n3. Pupils symmetric and bilaterally reactive\n4. Midline shift ≤5mm at the level of foramen of Monro on admission or post-operative brain CT\n5. Patent (complete or partial) quadrigeminal cisterns on admission or post-operative brain CT\n6. First randomization and intervention may be commenced within 24 hours of injury\n7. ELD safety score ≥5\n\nExclusion Criteria:\n\n1. GCS \\>8\n2. Cisterns on CT completely effaced\n3. Midline shift on CT \\>5mm\n4. GCS 3 with dilated and fixed pupils\n5. Uncal or tonsillar herniation on admission or post-operative brain CT\n6. Temporal lobe contusions with effaced ipsilateral cisterns\n7. Penetrating TBI\n8. Primary hemicraniectomy\n9. Pregnancy\n10. Prisoners\n11. Patients previously lacking capacity to consent or refuse treatment, or with advanced directives to forego aggressive care\n12. Pre-existing conditions affecting functional status or life expectancy to less than 1 year\n13. Contra-indications for ELD placement: coagulopathy, use of anticoagulants or anti-thrombotics, thrombocytopenia \\\u003C50,000, or severe spinal deformity.\n14. posterior fossa hemorrhage","65 Years",{"count":61,"type":20},30,[23],"The goal of this phase 1 randomized controlled safety and feasibility clinical trial are to determine the safety of external lumbar drainage (ELD) in select patients with severe Traumatic Brain Injury (TBI). The main questions it aims to answer are (i) if ELD is feasible and (ii) safe to perform in severe TBI patients who have radiological evidence of patent basal cisterns and midline shift \\\u003C5mm without increasing the risk of neurological worsening or cerebral herniation.\n\nAll participants will receive routine usual care. The study group will additionally have ELD for cerebrospinal fluid (CSF) drainage. A comparison will be made between the usual treatment plus ELD (interventional) groups, and the usual treatment (control) groups on incidence rate of neurological worsening or cerebral herniation events, and whether total hours with raised intracranial pressure (ICP) are different.",[65,28],"Severe Traumatic Brain Injury",[67,68,69,70],"Traumatic brain injury","intracranial pressure","intracranial hypertension","lumbar drainage","RECRUITING","2026-04-20",{"date":74,"type":42},"2026-04-22",{"date":76,"type":42},"2024-06-24",{"date":78,"type":20},"2028-06-30",{"name":80,"class":81},"Brain Trauma Foundation","OTHER",6,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":88,"conditions":96,"keywords":98,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100564814","phase-2-study-solace-sepsis-100564814","NCT06634069","Study SOLACE SEPSIS","A Pilot, Randomized, Double-Blinded, Controlled Study of Hemodynamic and Acid Base Effects of 0.5M Sodium Lactate and 3% Saline Solutions in Septic Shock Patients","MJIP1_0","Inclusion Criteria:\n\n* Subjects will be eligible for the trial if they meet all of the following criteria:\n\n  1. Age criteria: 18 - 90 years\n  2. Septic shock - Sepsis 3 criteria :\n\n     1. acute change in total SOFA score ≥ 2 due to infection\n     2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg\n     3. blood lactate level ≥ 2 mmol\u002FL within last 24 hours\n  3. Likely need for fluid resuscitation\n\n     1. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\\\u003C 0.5 ml\u002Fkg\u002Fhour for at least 6 hours) iii. central venous O2 saturation \\\u003C 70% iv. clouded sensorium\u002Fpoor mentation\n     2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and \u002F or stroke volume variation2, both \\> 12% iii. distensibility index of inferior vena caval diameter \\> 12%\n  4. Signed the relevant informed consent form\n\nExclusion Criteria:\n\n* Subjects will not be eligible for the trial if they meet any of the following criteria:\n\n  1. Poor transthoracic echo windows\n  2. Actual body weight \\> 160 kg\n  3. Hypernatremia: \\[Na\\] \\> 150 mEq\u002FL\n  4. Cardiac tamponade\n  5. Uncorrected severe valvular heart disease or life-threatening arrhythmia\n  6. Moribund patients likely to die before the study protocol is completed\n  7. Patients with absolute indication for immediate acute hemodialysis\u002Fhemofiltration (within 2 hrs) based on pH \\\u003C 7.0, K \\> 7.0mmol\u002FL\n  8. Severe liver dysfunction defined by total serum bilirubin \\> 120 umol\u002Fl\n  9. Pregnancy and lactation","90 Years",{"count":93,"type":20},40,[95],"PHASE2",[97,28],"Septic Shock",[69,99],"septic shock","2026-04-08",{"date":102,"type":42},"2026-04-14",{"date":104,"type":42},"2024-11-24",{"date":106,"type":20},"2027-10-31",{"name":108,"class":81},"University Hospital Pilsen",1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":109},"100625292","effects-of-extracorporeal-circulation-techniques-on-cerebral-perfusion-in-cabg-surgery-100625292","NCT07420738","Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery","The Effects of Different Extracorporeal Circulation Techniques on Cerebral Perfusion Markers and Postoperative Awakening in Coronary Artery Bypass Graft Surgery","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for elective coronary artery bypass graft (CABG) surgery\n* American Society of Anesthesiologists (ASA) physical status II-III\n* Planned use of extracorporeal circulation during surgery\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* ASA physical status other than II-III\n* Emergency surgery\n* Pregnancy\n* History of neurological disease affecting consciousness or decision-making capacity\n* History of psychiatric disease affecting decision-making capacity\n* History of head trauma within the previous 24 hours\n* Presence of carotid artery stenosis or significant carotid artery disease\n* Coagulation disorders (INR \\> 1.25, aPTT \\> 35 s, or platelet count \\\u003C 100,000\u002FμL)\n* Reoperation (redo cardiac surgery)\n* Congestive heart failure\n* Chronic kidney failure\n* Sepsis\n* Hypoxia\n* Ocular trauma\n* Optic nerve pathology","75 Years",{"count":119,"type":20},70,"OBSERVATIONAL","This prospective study aims to compare the effects of minimal invasive extracorporeal circulation (MiECC) and conventional reservoir-based extracorporeal circulation techniques on cerebral perfusion in patients undergoing elective coronary artery bypass graft (CABG) surgery. Although the adverse effects of cardiopulmonary bypass on cerebral perfusion and oxygenation are well recognized, the relationship between these effects and changes in intracranial pressure has not been fully elucidated. In this context, ultrasonographic measurement of optic nerve sheath diameter (ONSD), a non-invasive surrogate marker of intracranial pressure, will be used in combination with near-infrared spectroscopy (NIRS) to enable a comprehensive assessment of cerebral perfusion and oxygenation.\n\nBetween February 2026 and February 2027, a total of 70 ASA II-III patients scheduled for elective CABG surgery will be prospectively enrolled and allocated according to the extracorporeal circulation technique used. Perioperative ONSD measurements will be performed by a single anesthesiologist blinded to the perfusion technique. The primary endpoint is the comparison of perioperative changes in ONSD between the two techniques. Secondary endpoints include the correlation between ONSD and NIRS values, incidence of cerebrovascular events, extubation time, duration of intensive care unit and hospital stay, perioperative hemodynamic parameters, and postoperative complications. This study is expected to provide clinically relevant data on the cerebral effects of different extracorporeal circulation strategies and contribute to perioperative neuromonitoring practices in cardiac surgery.",[28],[124,125],"İntracranial pressure","optic nerve sheath diameter","2026-02-11",{"date":128,"type":42},"2026-02-19",{"date":130,"type":20},"2026-05-01",{"date":132,"type":20},"2027-05-01",{"name":134,"class":49},"Kartal Kosuyolu High Speciality Training and Research Hospital",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":144,"conditions":145,"keywords":149,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":109},"100587464","ocular-characteristics-in-patients-with-craniosynostosis-100587464","NCT06928727","Ocular Characteristics in Patients With Craniosynostosis","COPACA","Inclusion Criteria:\n\n* Diagnosis of craniostenosis\n\nExclusion Criteria:\n\n* Posterior plagiocephalia",{"count":143,"type":20},65,"Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In most cases, craniosynostoses are isolated with unknown (non syndrome). On the other hand, 20% of these deformations are associated with other concentration (syndrome).\n\nCraniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage.\n\nThis retrospective study aims to describe the ocular clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital.",[146,147,28,148],"Craniosynostosis","Strabismus","Amblyopia",[146,150,151,69],"strabismus","amblyopia","2026-02-10",{"date":154,"type":42},"2026-02-12",{"date":156,"type":42},"2025-04-04",{"date":158,"type":20},"2026-11",{"name":160,"class":81},"Centre Hospitalier Universitaire, Amiens",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":172,"conditions":173,"keywords":179,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100618485","optic-nerve-ultrasound-for-assessing-cerebral-inflammation-and-intracranial-hypertension-in-cerebral-pathologies-100618485","NCT07332234","Optic Nerve Ultrasound for Assessing Cerebral Inflammation and Intracranial Hypertension in Cerebral Pathologies","Utility of Optic Nerve Ultrasonography in Assessing Cerebral Inflammation and Intracranial Hypertension in Patients With Cerebral Impairment","EICON","Inclusion Criteria:\n\n* Patients admitted into one of the specified wards of the involved hospitals\n* Patients aged 18-60 years\n* Suspected meningitis, encephalitis, stroke or cerebral tumors\n\nExclusion Criteria:\n\n* Age under 18 years or over 60 years old\n* Ocular lesions preventing ocular ultrasound (palpebral infections, cornean erosions, glaucoma, trauma)\n* Conditions preventing lumbar puncture (coagulation disorders, epidural abscesses, local infections)","60 Years",{"count":171,"type":20},200,"Timely detection of signs of raised intracranial pressure or persistent inflammation within the meninges can expedite therapeutic decisions improving the prognosis of patients with brain damage. Optic nerve ultrasonography provides a user-friendly, safe, low-cost, and non-invasive imaging method that can be easily deployed for ICU patient assessment. This study aims to evaluate the sensitivity and specificity of optic nerve ultrasound in estimating cerebral inflammation extension and cerebral edema in patients in the ICU. The working hypothesis is that optic nerve ultrasound is a useful tool in the rapid diagnosis of cerebral edema and the presence or persistence of cerebral inflammation, which can enable adapted and rapid therapeutic interventions.",[174,175,176,177,28,178],"Meningitis","Meningitis\u002FEncephalitis","Stroke","Ultrasound","Cerebral Tumors",[180,181,182,174,183,176,184],"ONSD","Optic Nerve Sheath Diameter","Intracranial hypertension","Encephalitis","Cerebral tumors","2026-01-09",{"date":187,"type":42},"2026-01-12",{"date":189,"type":42},"2025-12-01",{"date":191,"type":20},"2027-12-01",{"name":193,"class":81},"Spitalul Clinic de Boli Infecțioase și tropicale \"Dr. Victor Babeș\"",2,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":109},"100397798","intracranial-pressure-time-dose-impeto-100397798","NCT04459806","Intracranial PrEssure Time dOse (ImPETO)","Evaluation of Intracranial Pressure Time Dose by the New Integra CereLink ICP Monitor","ImPETO","Inclusion Criteria:\n\n* Aged within 18 and 80 years;\n* Diagnosed of an acute brain injury (ABI) for hemorrhagic stroke (including intracerebral hematoma or subarachnoid hemorrhage) or traumatic brain injury;\n* ICP monitoring started for clinical indication and accordingly to local policies\n* ICP device connected to the Integra CereLink ICP monitor.\n\nExclusion Criteria:\n\n* ICP monitoring not inserted\n* No availability of the Integra CereLink ICP monitor.","80 Years",{"count":205,"type":20},250,"The new Integra CereLink ICP monitor integrate the possibility of recording and displaying continuously the AUC (Pressure Time Dose, PTD) and other ICP derived variables and provide the possibility of evaluating the utility of this information at the bedside. It offers the opportunity to test in a standardized way the clinical value of the PTD computation in this setting.\n\nTherefore, this study aims to test clinically if PTD recorded continuously is associated to patients' outcome and to identify a threshold of PTD associated with the transition from good to negative outcomes.",[28,208,26,209],"Traumatic Brain Injury","Intracranial Hemorrhages","2025-09-08",{"date":212,"type":42},"2025-09-15",{"date":214,"type":42},"2023-11-13",{"date":216,"type":20},"2026-12-31",{"name":218,"class":81},"University of Milano Bicocca",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":227,"enrollmentInfo":228,"targetDuration":230,"studyType":120,"phases":4,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100575771","effectiveness-of-surgical-procedures-for-acute-cranial-expansion-in-traumatic-brain-injury-100575771","NCT06776614","Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury","A Comparative-effectiveness Study on Expansion Craniotomy Versus Decompressive Craniectomy for Surgical Management of Traumatic Brain Injury in Patients With Intracranial Compartment Syndrome","E-SPACE-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal computed tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm at the same side of the CT´s primary injury or and\u002For an abnormal pupillometry with a reduced (Maximum Contraction Velocity) MCV in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans- Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Middle Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Pulse Wave (ICPPW) ICPPW2 \\> ICPPW1 waveform pattern in the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Cranial decompression or cranial expansion surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Cranial decompression or cranial expansion surgical procedures performed \\> 24 hours after the trauma.","70 Years",{"count":229,"type":20},292,"24 Months","Traumatic brain injury (TBI) patients often exhibit an increase in their intracranial volume due to blood collection or brain tissue edema. When the volume of any intracranial compartment exceeds a critical threshold, the compensatory mechanisms become exhausted, compromising intracranial compliance and blood supply, which leads to intracranial compartment syndrome (ICCS). The presence of this condition exacerbates brain damage through secondary injury. When less invasive measures to counteract ICCS prove to be insufficient, cranial decompression is recommended, with decompressive craniectomy (DC) being the preferred technique.\n\nAlthough its effectiveness has been demonstrated, DC is also associated with an incidence of complications. Expansive craniotomy (EC) has been proposed as an alternative that can increase the benefits of cranial decompression provided by DC while reducing the associated complications. This observational study will compare the functional outcomes and complications of patients managed by DC and EC.",[233,28],"Traumatic Brain Injuries",[208,235,236,237],"Intracranial Compartment Syndrome","Decompressive Craniectomy","Expansive Craniotomy","2025-05-05",{"date":240,"type":42},"2025-05-08",{"date":242,"type":20},"2025-07-08",{"date":244,"type":20},"2027-12-31",{"name":246,"class":81},"Meditech Foundation",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":227,"enrollmentInfo":255,"targetDuration":230,"studyType":120,"phases":4,"briefSummary":256,"conditions":257,"keywords":258,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":264,"locationsCount":4},"100575428","security-and-effectiveness-assessment-of-locking-systems-in-ventriculostomy-for-traumatic-brain-injury-100575428","NCT06772155","Security and Effectiveness Assessment of Locking Systems in Ventriculostomy for Traumatic Brain Injury","A Comparative Effectiveness Study on Catheter Locking Device Versus Standard Ventriculostomy for Surgical Management of Traumatic Brain Injury Patients With Intracranial Compartment Syndrome","SEALS-TBI","Inclusion Criteria:\n\n1. TBI patients arriving at the emergency room in the first 24 hours following trauma.\n2. Abnormal Computed Tomography (CT), with a primary injury including any epidural, intracerebral, or subdural collection with a midline shift \\>3 mm and any basal cistern compression with at least 2 abnormal findings in the initial evaluation at the emergency room (including optic nerve ultrasound \\> 6mm on the same side of the CT´s primary injury and\u002For an abnormal pupillometry with a reduced Maximum Contraction Velocity (MCV) in the pupil of the same side of the CT´s primary injury, or\u002Fand a Trans-Cranial Doppler (TCD) with Pulsatility Index (PI) \\> 1.3 and\u002For Medium Cerebral Artery - Diastolic Velocity (MCA-DV) \\\u003C 20cm\u002Fseg on the same side of the CT´s primary injury or\u002Fand an Intracranial Pressure Wave Form (ICPWF)2 \\> ICPWF1 waveform pattern on the same side of the CT´s primary injury).\n3. Age 18 to 70 years old.\n4. Patients with or without polytrauma with survival expectancy \\>24 hours.\n5. Ventriculostomy surgical procedures less than 24 hours after the trauma.\n\nExclusion Criteria:\n\n1. TBI patients arriving at the emergency room after 24 hours following trauma.\n2. Normal CT scan at the emergency room.\n3. Abnormal CT scan at the emergency room with any primary injury and midline shift less than 3mm or without basal cistern compression and with normal values in at least two different modalities of assessing ICCS (pupillometry, optic nerve sheath ultrasound, transcranial Doppler, and\u002For non-invasive ICP waveform analyzer).\n4. Age less than 18 or more than 70 years old.\n5. Polytrauma or massive brain injury with survival expectancy \\\u003C 24 hours.\n6. Ventriculostomy surgical procedures performed \\> 24 hours after the trauma.",{"count":229,"type":20},"This study aims to compare the effectiveness and safety of a standard intervention called ventriculostomy for managing increased intracranial pressure (ICP) in patients with severe traumatic brain injury (TBI). Elevated ICP is a critical condition that can result in brain damage or death if not treated promptly. The intervention will be performed in a traditional standard way or with an additional device called a catheter locking system. The first approach, standard ventriculostomy, involves placing a catheter into the brain's ventricular system to drain cerebrospinal fluid (CSF), thereby reducing ICP. The second approach incorporates the same catheter plus a catheter-locking device designed to secure the catheter in place, potentially reducing complications such as catheter displacement and the need for additional surgeries. Participants in this study will undergo either standard ventriculostomy or ventriculostomy with the locking device. Their progress will be observed during their hospital stay until the catheter is taken out (regularly on days 5th to 7th after the initial surgery) and assessed over one year through structured telephone follow-ups. The main outcomes include functional recovery, as measured by the Glasgow Outcome Scale Extended (GOSE), and the rate of complications such as operative site infections, catheter displacement, and\u002For reinterventions. By comparing these two methods, the study seeks to determine whether the locking device improves outcomes for TBI patients while maintaining or enhancing the safety and reliability of the procedure.",[233,28],[31,208,259],"Cranial Compartment Syndrome",{"date":240,"type":42},{"date":262,"type":20},"2025-07-05",{"date":244,"type":20},{"name":246,"class":81},{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":109},"100535646","lidocaine-dexmedetomidine-esmolol-and-magnesium-effect-on-optic-nerve-sheath-diameter-after-laryngoscopy-100535646","NCT06254534","Lidocaine, Dexmedetomidine, Esmolol and Magnesium Effect on Optic Nerve Sheath Diameter After Laryngoscopy","Effect of Lidocaine, Dexmedetomidine, Esmolol and Magnesium Use on Optic Nerve Sheath Diameter and Hemodynamic Response After Laryngoscopy: Randomized, Controlled, Double-blind Trial","Inclusion Criteria:\n\n* Patients aged 18 to 80 years who will receive endotracheal intubation for general anesthesia and have an American Society of Anesthesiologists (ASA) Physical Status classification of I to III.\n\nExclusion Criteria:\n\n* Patients allergic to dexmedetomidine, esmolol, lidocaine, and magnesium; patients with uncontrolled hypertension or advanced heart failure with EF below 35%; patients with cardiac arrhythmia, especially Type 2 and 3 blocks, supraventricular arrhythmias. Patients with renal failure (GFR below 30) or severe liver failure; patients with known acute or previous intracranial pathology and known diagnosis of epilepsy, predefined difficult airway examination. Patients who required more than one attempt at intubation or total laryngoscopy took more than 20 seconds.",{"count":273,"type":20},100,[23],"This clinical trial aims to compare the effects of lidocaine, dexmedetomidine, esmolol, and magnesium on optic nerve sheath diameter and hemodynamic response to laryngoscopy.\n\nThe participants will be patients determined to need intubation and general anesthesia for any elective surgery. Each participant will receive either lidocaine, dexmedetomidine, esmolol, magnesium, or none before anesthesia induction, according to randomization. The investigator will measure the optic nerve sheath diameter by ultrasonography before and after intubation. Researchers will compare the difference between optic nerve sheath diameter, systolic blood pressure, and heart rate before and after laryngoscopy and search for the most stable group. The trial aims to determine a general anesthesia induction protocol for patients sensitive to intracranial pressure changes reflected as optic nerve sheath diameter for easy monitoring.",[28,277,181,278],"Endotracheal Intubation","General Anesthesia","2025-03-16",{"date":281,"type":42},"2025-03-20",{"date":283,"type":42},"2024-02-14",{"date":285,"type":20},"2025-07",{"name":287,"class":81},"Haseki Training and Research Hospital",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":296,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":82},"100465387","non-invasive-measurement-with-trans-cranial-doppler-versus-invasive-measurement-in-pediatric-age-100465387","NCT05340062","Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age","The Accuracy of Intracranial Pressure Non Invasive Measurement With Trans Cranial Doppler Versus Invasive Measurement in Pediatric Age","nICPped","Inclusion Criteria:\n\n* invasive ICP placement\n\nExclusion Criteria:\n\n* cranial base fracture\n* absent informed consent",{"count":297,"type":20},46,"An increase of intracranial pressure (ICP) is an important cause of secondary brain damage. The gold standard for measuring ICP is represented by invasive positioning of intracranial ICP devices.\n\nThe most used non-invasive methods (nICP) are obtained through bed-side ultrasound, routinely used in the management of children in Pediatric Intensive Care: arterial Trancranial Doppler (TCD) and ultrasound measurement of the diameter of the optic nerve sheath (ONSD ).\n\nIn this study it is proposed to compare the measurement of nICP obtained by TCD and ONSD versus the measurement obtained by the invasive monitoring (iICP) already present.",[28],[69,301,302],"children","cerebral perfusion","2025-01-27",{"date":305,"type":42},"2025-01-28",{"date":307,"type":42},"2022-07-01",{"date":309,"type":20},"2025-12-31",{"name":311,"class":81},"Azienda Ospedaliera di Padova"]