Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05386303
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantitative Pupillometry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-18', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NPi (Neurological Pupil index) and EVD (external ventricular drain)occlusion test', 'timeFrame': '5 days', 'description': 'NPi will be compared between two groups of patients (constituted a posteriori): success and failure of the EVD occlusion test.\n\nIndependently of this study, the EDV occlusion test starts as soon as prescribed by the physician as a prerequisite before its withdrawal.\n\nFailing an occlusion test is defined by the need for reopening the EVD.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic evaluation', 'timeFrame': '5 days', 'description': 'Pupillometer ability to detect an EDV occlusion test failure will be studied. The area under the ROC curve (AUCROC) will be determined. We define, a priori, that the detection performance will be, respectively, honorable, good or excellent if the AUCROC is higher than 0.70, 0.80 and 0.90.'}, {'measure': 'Pupillometry and EVD occlusion test', 'timeFrame': '5 days', 'description': 'Constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.'}, {'measure': 'Dilatation velocity', 'timeFrame': '5 days', 'description': 'Dilation velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.'}, {'measure': 'Maximum constriction velocity', 'timeFrame': '5 days', 'description': 'Maximum constriction velocity will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.'}, {'measure': 'Latency of contraction', 'timeFrame': '5 days', 'description': 'Latency of contraction will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.'}, {'measure': 'Pupil size variation', 'timeFrame': '5 days', 'description': 'Pupil size variation will be compared between two groups of patients (constituted a posteriori): success and failure of the occlusion test.'}, {'measure': 'Pupillometry and clinical scores', 'timeFrame': '5 days', 'description': 'The association between pupillometry parameters and clinical scores (Glasgow Coma Scale, FOUR score, RASS and CAM-ICU) will be studied'}, {'measure': 'The association between pupillometry parameters and ventricular volume will be studied.', 'timeFrame': '5 days', 'description': 'A relationship between, measurements of ventricular volumes (via brain imaging examinations performed regardless of this study) and pupillometry parameters will be sought'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pupillometry', 'External ventricular drain', 'Weaning', 'Brain injury', 'Pupillary reactivity'], 'conditions': ['Hydrocephalus', 'Critical Care']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.', 'detailedDescription': 'Acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (EVD). In the aftermath, the patient is transferred to an intensive care unit (ICU) for close monitoring. Ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care.\n\nAssessing pupillary light reflex is a key test for the detection of neurological deterioration. For long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). For a more precise assessment, quantitative pupillometry has been proposed. Pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. This device is increasingly used in the ICU, mostly for prognostication after acute brain injury. We hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs.\n\nThe aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. The investigators focused on the early detection of hydrocephalus during the EVD weaning process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult ICU patients with an EVD included at the beginning of the weaning process', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Patient older than 18 years old\n* Admitted to the ICU\n* With an external ventricular drain\n* Consenting to participate (or consent from his/her next of kin, if unable to consent).\n\nExclusion Criteria :\n\n* Patient with pre-existing bilateral pupillary pathology\n* Pregnant or breast-feeding patient\n* Moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment\n* Patient with no health insurance\n* Patient under guardianship'}, 'identificationModule': {'nctId': 'NCT05386303', 'acronym': 'HYDRO-NiP', 'briefTitle': 'Quantitative Pupillometry', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Quantitative Pupillometry During External Ventricular Drain Weaning - An Observational Study', 'orgStudyIdInfo': {'id': 'RC21_0078'}}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nant', 'state': 'Loire-Atlantique', 'country': 'France', 'contacts': [{'name': 'Jérôme DAUVERGNE, IDE', 'role': 'CONTACT', 'email': 'jerome.dauvergne@chu-nantes.fr', 'phone': '33 (0) 2.40.16.52.89'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 44.02248, 'lon': 3.30123}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'contacts': [{'name': 'Jérôme Dauvergne', 'role': 'CONTACT', 'email': 'jerome.dauvergne@chu-nantes.fr'}], 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Jérôme DAUVERGNE, IDE', 'role': 'CONTACT', 'email': 'jerome.dauvergne@chu-nantes.fr', 'phone': '33 (0) 2.40.16.52.89'}], 'overallOfficials': [{'name': 'Jérôme DAUVERGNE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}