Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT03721003
Status:
UNKNOWN
Last Update Posted:
2018-10-26
First Post:
2018-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-24', 'studyFirstSubmitDate': '2018-09-29', 'studyFirstSubmitQcDate': '2018-10-24', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analyse role of ICP monitoring of patient with diffuse traumatic brain injury', 'timeFrame': 'one year', 'description': 'study the significance of application of ICP monitor on outcome of patients with diffuse traumatic brain injury using glascow coma scale The Glasgow Coma Scale (GCS) is a neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment. A patient is assessed against the criteria of the scale, and the resulting points give a patient score between 3 (indicating deep unconsciousness) and either 14 (original scale) or 15 (more widely used modified or revised scale)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head Injury Trauma']}, 'descriptionModule': {'briefSummary': 'Intracranial pressure (ICP) is defined as the pressure inside the skull, and therefore, the pressure inside the brain tissue and the cerebrospinal fluid (CSF). The relationship between CSF and intracranial blood volumes is described by the Monroe Kellie doctrine; because the brain is incompressible, when the skull is intact, the sum of the volumes of brain, CSF, and intracranial blood is constant.', 'detailedDescription': 'ICP \\>15 mmHg is considered to be elevated, and this is considered an important cause of secondary injury leading to irreversible brain injury and death. ICP monitoring is used in a number of conditions; traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, hydrocephalus, malignant infarction, cerebral oedema, CNS infections, hepatic encephalopathy, to name a few, and in all of these conditions ICP monitoring in the light of other parameters can influence management for better outcomes.\n\nThere are 4 ways to monitor intracranial pressure:\n\n1. An intra-parenchymal method, the catheter is placed into the brain parenchyma through a burr hole; it has a lower complication rate, lower infection rate, and no chance of catheter occlusion or leakage. Neurological injury is minimized because of the small diameter of the probe. In addition, malposition of the transducer has less impact on errors of measurement.\n2. An intra-ventricular method, the catheter is placed into one of the ventricles (lat. Ventricle). The catheter can also be used for therapeutic CSF drainage and for administration of drugs.\n3. Subdural method, this method is used if monitoring needs to be done right away. A hollow screw is inserted through a burr hole and placed through the Dura mater.\n4. An epidural sensor is inserted between the skull and dural tissue. This procedure is less invasive than other methods.\n\nICP monitoring methods is associated with a number of complications. These include risk of infection, haemorrhage, obstruction, difficulty in placement, malposition, etc.\n\nThe use of an ICP monitor is associated with significantly lower mortality when compared with patients treated without an ICP monitor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'history of present illness will be taken clinical assesment will be done ct brain will be done after that ICP monitor will be applied', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>18\n2. GCS \\< 8\n3. patient with severe brain insult ( Marshall class II to IV)\n4. patients admitted within 24 hours from the trauma time\n\nExclusion Criteria:\n\n1. Patients admitted for surgery (ex; surgical EDH) .\n2. patient diagnosed as brain death'}, 'identificationModule': {'nctId': 'NCT03721003', 'briefTitle': 'Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Centre Experience', 'orgStudyIdInfo': {'id': 'IPMISTBISCE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ICP monitoring', 'type': 'DEVICE', 'description': '4- Use the Touhy needle to tunnel under the scalp from the Burr Hole site to the desired MICROSENSOR exit site.\n\n5- Place the tip of the MICROSENSOR in the Parenchyma through the puncture in the Dura'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Mosab Samir', 'investigatorAffiliation': 'Assiut University'}}}}