Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT02002494
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2013-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Jugular Venous Flow Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emad.alazazi@uhnresearch.ca', 'phone': '416-603-8500', 'title': 'Emad Al Azazi', 'phoneExt': '6237', 'organization': 'Toronto Western Hospital/UHN'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Volunteers in Different Positions', 'description': 'The following will be compared in the same volunteer:\n\n* Bilateral internal jugular venous flow in supine and prone position\n* Bilateral internal jugular venous flow in supine and park bench position\n* Bilateral internal jugular venous flow in prone and park bench\n\nDifferent positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Internal Jugular Venous (IJV) Cross Sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': 'Comparisons of right internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.'}, {'id': 'OG001', 'title': 'L IJV', 'description': 'Comparisons of left internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.'}], 'classes': [{'title': 'Supine-Cross sectional area', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Prone-Cross sectional area', 'categories': [{'measurements': [{'value': '1.8', 'spread': '1', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Twenty-seven volunteers were included in this study. Comparisons of right and left internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and prone position.'}, {'type': 'PRIMARY', 'title': 'Right and Left IJV Cross Sectional Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': '\\- We studied R IJV flow in the supine and right park bench positions respectively.\n\nall measurements were performed on the right eye in a neutral gaze.\n\n\\- We standardised the use of the right side because of ease of access to that side in the laboratory.'}, {'id': 'OG001', 'title': 'L IJV', 'description': '\\- We studied L IJV flow in the supine and right park bench positions respectively.\n\nall measurements were performed on the right eye in a neutral gaze.\n\n\\- We standardised the use of the right side because of ease of access to that side in the laboratory.'}], 'classes': [{'title': 'Supine-Cross sectional area (cm2)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Right park bench-Cross sectional area', 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons of bilateral internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and right park bench position.'}, {'type': 'PRIMARY', 'title': 'Internal Jugular Venous (IJV) Doppler Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': 'Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and prone position.'}, {'id': 'OG001', 'title': 'L IJV', 'description': 'Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and prone position.'}], 'classes': [{'title': 'Supine Doppler velocity', 'categories': [{'measurements': [{'value': '19.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Prone Doppler velocity', 'categories': [{'measurements': [{'value': '19.3', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': '27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions', 'unitOfMeasure': 'cm.sec-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and prone position. Data presented as mean (SD) .'}, {'type': 'PRIMARY', 'title': 'Bilateral Internal Jugular Vein (IJV) Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': 'Comparisons of right internal jugular vein (IJV) flow between supine and prone position.'}, {'id': 'OG001', 'title': 'L IJV', 'description': 'Comparisons of left internal jugular vein (IJV) flow between supine and prone position.'}], 'classes': [{'title': 'Supine Flow', 'categories': [{'measurements': [{'value': '1430.1', 'spread': '803', 'groupId': 'OG000'}, {'value': '1112.9', 'spread': '578.1', 'groupId': 'OG001'}]}]}, {'title': 'Prone Flow', 'categories': [{'measurements': [{'value': '1924.2', 'spread': '1139.7', 'groupId': 'OG000'}, {'value': '1178.4', 'spread': '832.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .', 'unitOfMeasure': 'ml.min-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .'}, {'type': 'PRIMARY', 'title': 'Bilateral Internal Jugular Vein (IJV) Doppler Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': 'Comparisons of right internal jugular vein (IJV) Doppler velocity between supine and right park bench position'}, {'id': 'OG001', 'title': 'L IJV', 'description': 'Comparisons of left internal jugular vein (IJV) Doppler velocity between supine and right park bench position'}], 'classes': [{'title': 'supine Doppler velocity', 'categories': [{'measurements': [{'value': '19.9', 'spread': '7', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'right park bench Doppler velocity', 'categories': [{'measurements': [{'value': '28.1', 'spread': '12', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.', 'unitOfMeasure': 'cm.sec-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons of bilateral internal jugular vein (IJV) cross sectional area, Doppler velocity and flow between supine and right park bench position. Data presented as mean (SD).'}, {'type': 'PRIMARY', 'title': 'R IJV and L IJV Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'R IJV', 'description': 'Comparisons of right internal jugular vein (IJV) Flow between supine and right park bench position'}, {'id': 'OG001', 'title': 'L IJV', 'description': 'Comparisons of left internal jugular vein (IJV) Flow between supine and right park bench position'}], 'classes': [{'title': 'supine Flow', 'categories': [{'measurements': [{'value': '1430.1', 'spread': '803', 'groupId': 'OG000'}, {'value': '1112.9', 'spread': '578.1', 'groupId': 'OG001'}]}]}, {'title': 'right park bench Flow', 'categories': [{'measurements': [{'value': '1403.1', 'spread': '1006.1', 'groupId': 'OG000'}, {'value': '1266.9', 'spread': '959.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Bilateral internal jugular vein (IJV) flow between supine and right park bench position.', 'unitOfMeasure': 'ml.min-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparisons of bilateral internal jugular vein (IJV) flow between supine and right park bench position. Data presented as mean (SD).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Volunteers in Different Positions', 'description': 'The following will be compared in the same volunteer:\n\n* Bilateral internal jugular venous flow in supine and prone position\n* Bilateral internal jugular venous flow in supine and park bench position\n* Bilateral internal jugular venous flow in prone and park bench Different positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Twenty-seven volunteers were included in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Volunteers in Different Positions', 'description': 'The following will be compared in the same volunteer:\n\n* Bilateral internal jugular venous flow in supine and prone position\n* Bilateral internal jugular venous flow in supine and park bench position\n* Bilateral internal jugular venous flow in prone and park bench\n\nDifferent positions: Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '38', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.5', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '15.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Twenty-seven volunteers were included in this study. The mean (SD) age, height and weight of these participants were analyzed.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2013-11-29', 'resultsFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2013-12-04', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-21', 'studyFirstPostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Internal Jugular Venous (IJV) Cross Sectional Area', 'timeFrame': '1 day', 'description': 'Comparisons of both jugular vein (IJV) of twenty-seven volunteers in supine and prone positions.'}, {'measure': 'Right and Left IJV Cross Sectional Area', 'timeFrame': '1 day', 'description': 'Twenty-seven volunteers were included in this study. Comparisons of cross sectional area measurements in both IJVs between supine and right park bench'}, {'measure': 'Internal Jugular Venous (IJV) Doppler Velocity', 'timeFrame': '1 day', 'description': '27 volunteers enrolled to measure the Internal Jugular Venous (IJV) in supine and prone positions'}, {'measure': 'Bilateral Internal Jugular Vein (IJV) Flow', 'timeFrame': '1 day', 'description': 'Comparisons of bilateral internal jugular vein (IJV) flow between supine and prone position. Data presented as mean (SD) .'}, {'measure': 'Bilateral Internal Jugular Vein (IJV) Doppler Velocity', 'timeFrame': '1 day', 'description': 'Comparisons of bilateral internal jugular vein (IJV) Doppler velocity between supine and right park bench position.'}, {'measure': 'R IJV and L IJV Flow', 'timeFrame': '1 day', 'description': 'Bilateral internal jugular vein (IJV) flow between supine and right park bench position.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Jugular Venous Blood Flow']}, 'descriptionModule': {'briefSummary': 'Our hypothesis is that there will be a decrease in internal jugular venous flow in the park bench position when compared to the supine position. There will also be a change in blood flow in the between right and left internal jugular veins in park bench position, particularly there will be a greater reduction of flow on the dependent side. However, the internal jugular venous flow will be the same in both the prone and supine position.', 'detailedDescription': 'The different positions used in neurosurgery (park bench, prone) for better accessibility to the operating field can impact on the cerebral venous drainage due to the effects of internal jugular venous outflow of blood and may increase intracranial pressure. The kinking of the internal jugular vein due to excessive neck flexion and rotation in park bench or flexion in the prone position may lead to kinking or twisting of the vein. This has been hypothesized as the major cause of disturbed venous drainage during surgery and in postoperative patients may lead to neck swelling, brachial plexus injury, macroglossia (swollen tongue), delayed airway obstruction and increases in intracranial pressure.\n\nOptimal brain perfusion is best in the neutral position of the head, but surgery cannot always be performed with this. Thus, we look to measure the internal jugular venous flow at different positions as there have been little studies looking at this important contributing factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy volunteers who are above the age of 18\n* American Society of Anesthesiologists classification (ASA) 1\n* Body mass index (BMI) less than and equal to 35\n\nExclusion Criteria:\n\n* ASA 2 and above\n* BMI above 35\n* Lack of informed consent\n* Language barrier\n* Medical students and anaesthesia residents going through the department as part of their rotation'}, 'identificationModule': {'nctId': 'NCT02002494', 'briefTitle': 'Jugular Venous Flow Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Effect of Different Surgical Positions on the Cerebral Venous Drainage: an Ultrasound Study on Healthy Volunteers', 'orgStudyIdInfo': {'id': '13-6244-BE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'volunteers in different positions', 'description': 'The following will be compared in the same volunteer:\n\n* Bilateral internal jugular venous flow in supine and prone position\n* Bilateral internal jugular venous flow in supine and park bench position\n* Bilateral internal jugular venous flow in prone and park bench', 'interventionNames': ['Other: Different positions']}], 'interventions': [{'name': 'Different positions', 'type': 'OTHER', 'description': 'Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench', 'armGroupLabels': ['volunteers in different positions']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Lashmi Venkatraghavan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto Western Hospital'}, {'name': 'Vincent Chan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto Western Hospital'}, {'name': 'Pirjo Manninen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto Western Hospital'}, {'name': 'Audrey MY Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto Western Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Lashmi Venkatraghavan', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}