Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT06350656
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2023-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-03-31', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracranial pressure (mmHg)', 'timeFrame': 'Year : 1', 'description': 'Intracranial pressure is measured before (Raising the head by 30°) and during the flattening (Raising the head by 0°).\n\nTheses measures are done twice a day.\n\nThe mean of theses values is calculated.'}], 'secondaryOutcomes': [{'measure': 'Correlation between ICP (Intra Cranial Pressure) doses and cerebral compliance', 'timeFrame': 'Year : 1', 'description': 'Compare the ICP (Intra Cranial Pressure) dose value with the compliance index during the period before or after the flattening'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebrospinal compliance', 'Intracranial pressure.', 'Head injury', 'Pulse waveform'], 'conditions': ['Cerebrospinal; Disorder']}, 'descriptionModule': {'briefSummary': 'Despite the massive use of intracranial pressure in neuro-resuscitation, there is still no cerebral compliance evaluation index used in current practice to guide therapy.\n\nIn treatment guidelines for intracranial hypertension, patients are placed in a prone position at about 30 degrees. Several times a day, during nursing care, patients are flattened, which corresponds to a cerebral compliance test by adding a volume of cerebrospinal fluid to the cranial box.', 'detailedDescription': 'This study aims to analyse the shape of the different components of the intracranial pressure waves (P1, P2, and P3) when the patient is flattened to determine an index to define the level of cerebral compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sedated patient on mechanical ventilation with continuous intracranial pressure monitoring', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Continuous intracranial pressure monitoring\n* Sedated patient on mechanical ventilation\n\nExclusion Criteria:\n\n* Craniectomy\n* Major hemodynamic failure'}, 'identificationModule': {'nctId': 'NCT06350656', 'acronym': 'EC2', 'briefTitle': 'Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Study of Cerebral Compliance in Neurosurgical Intensive Care Units (EC2)', 'orgStudyIdInfo': {'id': 'IRBN282022/CHUSTE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Clinical data collection', 'type': 'OTHER', 'description': 'Post-retrieval from the medical record'}, {'name': 'Therapeutic data collection', 'type': 'OTHER', 'description': 'Post-retrieval from the medical record'}, {'name': 'IntraCranial Pression (ICP) values collection', 'type': 'OTHER', 'description': 'Post-retrieval of ICP values from the monitor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69970', 'city': 'Chaponnay', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'PIERRE-HENRI MURGAT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CENTRE HOSPITALIER Charponnay', 'geoPoint': {'lat': 45.62762, 'lon': 4.93615}}, {'zip': '38000', 'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JEAN FRANCOIS PAYEN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CENTRE HOSPITALIER UNIVERSITAIRE Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38170', 'city': 'La Tronche', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'KEVIN LAGARDE, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HOPITAL NORD La Tronche', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'SAMUEL GAUGUIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'APHP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'JEROME CARTAILLIER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Lariboisiere - Ahph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'YOANN LAUNEY, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CENTRE HOSPITALIER UNIVERSITAIRE Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '42055', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'CLEMENT MAGAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CENTRE HOSPITALIER UNIVERSITAIRE Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'LAURENT GERGELE, MD', 'role': 'CONTACT', 'email': 'laurent.gergele@chu-st-etienne.fr', 'phone': '(0)477828593', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'LAURENT GERGELE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU DE SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}