Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT02830269
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2016-06-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2016-06-10', 'studyFirstSubmitQcDate': '2016-07-08', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Third ventricle diameter (average +/- standard deviation)', 'timeFrame': 'Through study completion (30 months)', 'description': "Spearman's test measuring the correlation coefficient between the third ventricle diameter measured by the expert using the ultrasonography and the third ventricle diameter measured by CT scan."}], 'secondaryOutcomes': [{'measure': "Residents' learning curve", 'timeFrame': '24 months', 'description': "The learning curve will be determined by the change in the third ventricle diameter's difference obtained by the expert and the resident, divided by the diameter obtained by the expert reported on the Y-axis and the number of measures done by the resident reported on the X-axis. Number of measures to be done will be determined when the curve reached the zero."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neuro-ICU', 'Third ventricle', 'Computer Tomography', 'Transcranial Doppler ultrasonography'], 'conditions': ['Neuro-intensive Care Unit Patients', 'Brain Injuries']}, 'referencesModule': {'references': [{'pmid': '33945045', 'type': 'DERIVED', 'citation': 'Widehem R, Bory P, Greco F, Pavillard F, Chalard K, Mas A, Djanikian F, Carr J, Molinari N, Jaber S, Perrigault PF, Chanques G. Transcranial sonographic assessment of the third ventricle in neuro-ICU patients to detect hydrocephalus: a diagnostic reliability pilot study. Ann Intensive Care. 2021 May 4;11(1):69. doi: 10.1186/s13613-021-00857-x.'}]}, 'descriptionModule': {'briefSummary': 'Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler ultrasonography was not validated for neuro-intensive care unit patients. The investigators propose to used recent ultrasound system to validate the third ventricle diameter measurements in comparison with the standard method (CT).', 'detailedDescription': 'Transcranial Doppler ultrasonography is usually used in the evaluation and management of patients with brain injury. This noninvasive method measures local blood flow velocity and direction in the proximal portions of large intracranial arteries. The operator requires a short training and experience to perform. The third ventricle diameter measurement by transcranial duplex flow sonography was performed in healthy volunteers . This studies show similar results in those obtained with the MRI or Computer Tomography (CT). Currently the third ventricle diameter measurements by transcranial Doppler'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted to the neurointensive care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult, \\> or equal to 18-yr\n* Admission to neuro-intensive care unit with brain injury\n* Evaluation by Computer Tomography\n* Indication for Transcranial Doppler ultrasonography\n\nExclusion Criteria:\n\n* Opposition to participate by the patient or a next of kin'}, 'identificationModule': {'nctId': 'NCT02830269', 'acronym': 'ECHO-V3', 'briefTitle': 'Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Third Ventricle Echographic Study for Neuro-intensive Care Unit Patients', 'orgStudyIdInfo': {'id': '9720'}, 'secondaryIdInfos': [{'id': '2016-A00749-42', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Transcranial Doppler ultrasonography measurements', 'type': 'DEVICE', 'description': 'Third ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UHMontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'GERALD CHANQUES, MD, Ph D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Pierre-François PERRIGAULT, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Paul BORY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}