Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-06 @ 1:21 AM
Study NCT ID:
NCT01790334
Status:
COMPLETED
Last Update Posted:
2013-08-29
First Post:
2013-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2013-02-11', 'studyFirstSubmitQcDate': '2013-02-11', 'lastUpdatePostDateStruct': {'date': '2013-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparing the size of right internal jugular vein in different mechanical ventilation modes', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'effect of different head positions on the right internal jugular vein size', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Central Line Complication']}, 'referencesModule': {'references': [{'pmid': '9526929', 'type': 'RESULT', 'citation': 'Lobato EB, Florete OG Jr, Paige GB, Morey TE. Cross-sectional area and intravascular pressure of the right internal jugular vein during anesthesia: effects of Trendelenburg position, positive intrathoracic pressure, and hepatic compression. J Clin Anesth. 1998 Feb;10(1):1-5. doi: 10.1016/s0952-8180(97)00189-x.'}]}, 'descriptionModule': {'briefSummary': 'It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase.\n\nThe aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery under endotracheal intubation will be included in this random, prospective, clinical study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery\n\nExclusion Criteria:\n\n* Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT01790334', 'acronym': 'USG-IJV', 'briefTitle': 'Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparing the Size of the Vena Jugular Interna Under Spontaneous Ventilation and Different Mechanical Ventilation Modes When Head is in Neutral and 30 Degree Lateral Position:Clinical Trial', 'orgStudyIdInfo': {'id': '32488'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spontenous Ventilation (Group S)', 'description': 'ultrasonography of Right internal jugular vein', 'interventionNames': ['Other: Ultrasonography']}, {'label': 'Pressure control Ventilation (Group P)', 'description': 'ultrasonography of Right internal jugular vein', 'interventionNames': ['Other: Ultrasonography']}, {'label': 'Volume control ventilation (Group V)', 'description': 'ultrasonography of Right internal jugular vein', 'interventionNames': ['Other: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'OTHER', 'otherNames': ['The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography'], 'armGroupLabels': ['Pressure control Ventilation (Group P)', 'Spontenous Ventilation (Group S)', 'Volume control ventilation (Group V)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34400', 'city': 'Istanbul', 'state': 'Fatih', 'country': 'Turkey (Türkiye)', 'facility': 'Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof. M.D.', 'investigatorFullName': 'Guniz M.Koksal', 'investigatorAffiliation': 'Istanbul University'}}}}