Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-30 @ 6:32 PM
Study NCT ID:
NCT05213832
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Inhalatory Sedation in Subarachnoid Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2022-01-16', 'studyFirstSubmitQcDate': '2022-01-16', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral blood flow recondtion', 'timeFrame': '20 minutes', 'description': 'The percentage of subjects who had a flow recondition at the second CT at least 50% of the best value detected in the first perfusion CT scan'}], 'secondaryOutcomes': [{'measure': 'Changes in intracranial pressure during isoflurane delivery', 'timeFrame': '20 minutes', 'description': 'We evaluate if isofluorane create an increase in ICP trough continuous monitoring.'}, {'measure': 'Changes in blood pressure during isoflurane delivery', 'timeFrame': '20 minutes', 'description': 'By its vasodilatatore effect, we monitored punctually if mean arterial blood pressure will increase during isofluorane delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['perfusion', 'isofluorane', 'inhalatory', 'sedation'], 'conditions': ['Subarachnoid Hemorrhage', 'Aneurysmal Subarachnoid Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.\n\nIt will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.\n\nPerfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old\n* Diagnosis of non-traumatic SAH\n* Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥ 3.\n* Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.\n* Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.\n* Acceptance of informed consent.\n\nExclusion Criteria:\n\n* Documented outcomes of cerebrovascular disease\n* Patients with acute heart failure related to ESA\n* State of pregnancy\n* Patients with CLCR \\< 30 mL/min'}, 'identificationModule': {'nctId': 'NCT05213832', 'acronym': 'INSPIRE', 'briefTitle': 'Effect of Inhalatory Sedation in Subarachnoid Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'A.O.U. Città della Salute e della Scienza'}, 'officialTitle': 'Effect of Inhalatory Sedation on Cerebral Perfusion in Subarachnoid Hemorrhage', 'orgStudyIdInfo': {'id': '0076379'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Inhalatory group', 'description': 'Patience with severe SAH (WFNS \\> 3) are enrolled in the study. In these patients we administered a inhalatory dose of Isofluorane', 'interventionNames': ['Drug: Isoflurane Inhal Soln']}], 'interventions': [{'name': 'Isoflurane Inhal Soln', 'type': 'DRUG', 'description': 'Administration of isofluorane in patients with severe SAH', 'armGroupLabels': ['Inhalatory group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza - Presidio CTO', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Maurizio Berardino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU Città della Salute e della Scienza'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Anesthesia and Intensive Care Unit Departement', 'investigatorFullName': 'Maurizio Berardino', 'investigatorAffiliation': 'A.O.U. Città della Salute e della Scienza'}}}}