Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT03867461
Status:
COMPLETED
Last Update Posted:
2020-05-12
First Post:
2019-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of MAP and EtCO2 on Venous Sinus Pressures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011559', 'term': 'Pseudotumor Cerebri'}], 'ancestors': [{'id': 'D019586', 'term': 'Intracranial Hypertension'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-15', 'size': 154274, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-05-08T09:59', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2019-03-06', 'studyFirstSubmitQcDate': '2019-03-07', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Venous Sinus Pressures', 'timeFrame': 'Baseline'}, {'measure': 'Venous Sinus Pressures', 'timeFrame': 'After intervention, up to 5 minutes'}], 'secondaryOutcomes': [{'measure': 'Venous Sinus Diameter', 'timeFrame': 'Baseline'}, {'measure': 'Venous Sinus Diameter', 'timeFrame': 'After Intervention, up to 5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['End-Tidal Carbon Dioxide', 'Venous Sinus Stenting', 'Venous Sinus Caliber and Pressures'], 'conditions': ['Idiopathic Intracranial Hypertension']}, 'referencesModule': {'references': [{'pmid': '26251432', 'type': 'BACKGROUND', 'citation': 'Satti SR, Leishangthem L, Chaudry MI. Meta-Analysis of CSF Diversion Procedures and Dural Venous Sinus Stenting in the Setting of Medically Refractory Idiopathic Intracranial Hypertension. AJNR Am J Neuroradiol. 2015 Oct;36(10):1899-904. doi: 10.3174/ajnr.A4377. Epub 2015 Aug 6.'}, {'pmid': '24999351', 'type': 'BACKGROUND', 'citation': 'Teleb MS, Cziep ME, Lazzaro MA, Gheith A, Asif K, Remler B, Zaidat OO. Idiopathic Intracranial Hypertension. A Systematic Analysis of Transverse Sinus Stenting. Interv Neurol. 2013;2(3):132-143. doi: 10.1159/000357503.'}, {'pmid': '27199383', 'type': 'BACKGROUND', 'citation': 'Levitt MR, Albuquerque FC, Gross BA, Moon K, Jadhav AP, Ducruet AF, Crowley RW. Venous sinus stenting in patients without idiopathic intracranial hypertension. J Neurointerv Surg. 2017 May;9(5):512-515. doi: 10.1136/neurintsurg-2016-012405. Epub 2016 May 19.'}, {'pmid': '21799038', 'type': 'BACKGROUND', 'citation': 'Ahmed RM, Wilkinson M, Parker GD, Thurtell MJ, Macdonald J, McCluskey PJ, Allan R, Dunne V, Hanlon M, Owler BK, Halmagyi GM. Transverse sinus stenting for idiopathic intracranial hypertension: a review of 52 patients and of model predictions. AJNR Am J Neuroradiol. 2011 Sep;32(8):1408-14. doi: 10.3174/ajnr.A2575. Epub 2011 Jul 28.'}, {'pmid': '29563210', 'type': 'BACKGROUND', 'citation': 'West JL, Garner RM, Greeneway GP, Traunero JR, Aschenbrenner CA, Singh J, Wolfe SQ, Fargen KM. Venous waveform morphological changes associated with treatment of symptomatic venous sinus stenosis. J Neurointerv Surg. 2018 Nov;10(11):1108-1113. doi: 10.1136/neurintsurg-2018-013858. Epub 2018 Mar 21.'}, {'pmid': '27634954', 'type': 'BACKGROUND', 'citation': 'Fargen KM, Spiotta AM, Hyer M, Lena J, Turner RD, Turk AS, Chaudry I. Comparison of venous sinus manometry gradients obtained while awake and under general anesthesia before venous sinus stenting. J Neurointerv Surg. 2017 Oct;9(10):990-993. doi: 10.1136/neurintsurg-2016-012608. Epub 2016 Sep 15.'}, {'pmid': '28360352', 'type': 'BACKGROUND', 'citation': 'Raper DMS, Buell TJ, Chen CJ, Ding D, Starke RM, Liu KC. Intracranial venous pressures under conscious sedation and general anesthesia. J Neurointerv Surg. 2017 Oct;9(10):986-989. doi: 10.1136/neurintsurg-2017-012984. Epub 2017 Mar 30.'}, {'pmid': '30266712', 'type': 'BACKGROUND', 'citation': 'West JL, Garner RM, Traunero JR, Wolfe SQ, Fargen KM. Changes in End-Tidal Carbon Dioxide Partial Pressure Alter Venous Sinus Pressure Measurements in Idiopathic Intracranial Hypertension. World Neurosurg. 2018 Dec;120:495-499. doi: 10.1016/j.wneu.2018.09.117. Epub 2018 Sep 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to further elaborate the role of both arterial blood pressure and end-tidal carbon dioxide concentration on measured venous pressures.', 'detailedDescription': 'To prospectively evaluate the effect of changes in end-tidal carbon dioxide and arterial blood pressure on venous sinus pressure measurements in patients undergoing venous sinus stenting under general anesthesia. Venous sinus pressure measurements will increase with increases in both arterial blood pressure and end-tidal carbon dioxide concentrations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults determined to be candidates for venous sinus stenting'}, 'identificationModule': {'nctId': 'NCT03867461', 'briefTitle': 'The Effects of MAP and EtCO2 on Venous Sinus Pressures', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Prospective Measurement of Blood Pressure and End Tidal Carbon Dioxide Content Effects on Venous Sinus Caliber and Pressures in Patients With Idiopathic Intracranial Hypertension Undergoing Stenting', 'orgStudyIdInfo': {'id': 'IRB00055942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'Adult patients determined to be candidates for venous sinus stenting.\n\nEnd tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:\n\nFor Group A: Initial Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-80 mmHg, End tidal CO2 38-40 mmHg.', 'interventionNames': ['Procedure: Venous Sinus Stenting', 'Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)', 'Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Adult patients determined to be candidates for venous sinus stenting.\n\nEnd tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:\n\nFor Group B: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 60-80 mmHg, End tidal CO2 38-40 mmHg,', 'interventionNames': ['Procedure: Venous Sinus Stenting', 'Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)', 'Other: Adjustment to Mean Arterial Pressure (60-80 mmHg range)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Adult patients determined to be candidates for venous sinus stenting.\n\nEnd tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:\n\nFor Group C: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 24-26 mmHg, Subsequent Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg,', 'interventionNames': ['Procedure: Venous Sinus Stenting', 'Other: Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)', 'Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'Adult patients determined to be candidates for venous sinus stenting.\n\nEnd tidal CO and Mean Arterial Pressure will be adjusted to the following parameters during the intervention:\n\nFor Group D: Initial Recording: Mean Arterial Pressure 100-110 mmHg, End tidal CO2 38-40 mmHg, Subsequent Recording: Mean Arterial Pressure 100-100 mmHg, End tidal CO2 24-24 mmHg,', 'interventionNames': ['Procedure: Venous Sinus Stenting', 'Other: Adjustment to Mean Arterial Pressure (100-110 mmHg range)', 'Other: Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)']}], 'interventions': [{'name': 'Venous Sinus Stenting', 'type': 'PROCEDURE', 'description': 'Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)', 'type': 'OTHER', 'description': 'End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Adjustment to Mean Arterial Pressure (100-110 mmHg range)', 'type': 'OTHER', 'description': 'Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range', 'armGroupLabels': ['Group A', 'Group C', 'Group D']}, {'name': 'Adjustment to Mean Arterial Pressure (60-80 mmHg range)', 'type': 'OTHER', 'description': 'Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range', 'armGroupLabels': ['Group B']}, {'name': 'Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)', 'type': 'OTHER', 'description': 'End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'Kyle Fargen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}