Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-01 @ 8:49 AM
Study NCT ID:
NCT06403592
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-03', 'studyFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2024-05-03', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of insertion of a laryngeal airway mask on optic nerve sheath diameter', 'timeFrame': 'During surgery'}], 'secondaryOutcomes': [{'measure': 'Effect of laryngeal ariway mask after insertion on optic nerve sheath diameter', 'timeFrame': 'During surgery'}, {'measure': 'Effect of layngeal airway mask on optic nerve sheath diameter interna vs optic nerve sheath diameter externa', 'timeFrame': 'During surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laryngeal airway mask', 'Optic Nerve sheath Diameter', 'Intracranial Pressure'], 'conditions': ['Intracranial Pressure Increase']}, 'descriptionModule': {'briefSummary': 'The goal of this observational trial is to study the effect of a laryngeal airway mask on the optic nerve sheath diameter, as a surrogate for intracranial pressure.\n\nThe optic nerve sheath diameter of participants will be measured under general anesthesia, before, during and after insertion of a laryngeal airway mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-II patients scheduled for surgery under general anesthesia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria: aged 18 years or older, ASA I or ASA II, scheduled for elective surgery under general anesthesia, with a planned duration of \\> 30 minutes, that can be routinely performed with a LMA.\n\nExclusion Criteria:\n\n* Scheduled for head or neck surgery\n* Scheduled for neurosurgery\n* Scheduled for laparoscopic or thorascoscopic procedures\n* Scheduled for procedures that require Trendelenburg or anti-Trendelenburg positioning\n* Neurological disorders\n* Glaucoma\n* History of bilateral eye related trauma\n* Intellectual disability'}, 'identificationModule': {'nctId': 'NCT06403592', 'acronym': 'ONSD laryngeal', 'briefTitle': 'The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'The Effect of a Laryngeal Mask Airway on Optic Nerve Sheath Diameter', 'orgStudyIdInfo': {'id': 'ONSD laryngeal'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational cohort', 'description': 'ASA I-II patients scheduled for surgery under general anesthesia with a laryngeal airway mask', 'interventionNames': ['Other: optic nerve sheath diamater']}], 'interventions': [{'name': 'optic nerve sheath diamater', 'type': 'OTHER', 'description': 'Measurement of optic nerve sheath diameter', 'armGroupLabels': ['Observational cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Maissan', 'role': 'CONTACT'}], 'facility': 'Erasmus Medisch Centrum', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Dr. Maissan', 'role': 'CONTACT', 'email': 'i.maissan@erasmusmc.nl', 'phone': '+31628552301'}, {'name': 'Rutger Hollestelle', 'role': 'CONTACT', 'email': 'r.hollestelle@erasmusmc.nl', 'phone': '+31613997877'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Iscander M Maissan', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}