Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 5:23 AM
Study NCT ID:
NCT02456259
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2015-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2015-05-24', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative patency of internal jugular vein', 'timeFrame': '7 days', 'description': 'Comparison of ultrasound findings on right internal jugular vein preoperatively and 7 days after operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['internal jugular vein patency', 'MICS', 'neck cannula', 'Jugular veins'], 'conditions': ['Cardiac Surgical Procedure']}, 'referencesModule': {'references': [{'pmid': '22361820', 'type': 'BACKGROUND', 'citation': 'Vernick WJ, Woo JY. Anesthetic considerations during minimally invasive mitral valve surgery. Semin Cardiothorac Vasc Anesth. 2012 Mar;16(1):11-24. doi: 10.1177/1089253211434591. Epub 2012 Feb 22.'}, {'pmid': '25575244', 'type': 'BACKGROUND', 'citation': 'Brass P, Hellmich M, Kolodziej L, Schick G, Smith AF. Ultrasound guidance versus anatomical landmarks for internal jugular vein catheterization. Cochrane Database Syst Rev. 2015 Jan 9;1(1):CD006962. doi: 10.1002/14651858.CD006962.pub2.'}]}, 'descriptionModule': {'briefSummary': "The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing each year. MICS procedures on atrioventricular valves are usually performed without conventional sternotomy, an alternative approach is from right anterolateral minithoracotomy. This surgical approach has essential impact both on anesthesia techniques and cardiopulmonary bypass (CPB) settings. Specific anesthesiological procedure is an insertion of neck venous cannula of CPB through the right internal jugular vein into the superior vena cava both for partial and total bypass. The size of neck cannula is between 15 and 21 French depending on the type of surgical procedure and patient's weight. Central venous catheter and eventually sheath are also inserted into the right internal jugular vein. Thus, there is a relevant question regarding postoperative patency of right internal jugular vein in patients undergoing MICS procedures requiring an insertion of neck cannula of CPB. The investigators hypothesize, there is no significant difference in postoperative patency of internal jugular vein assessed by ultrasound in patient undergoing cardiac surgery with and without neck cannula of CPB"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing cardiac surgery both from conventional sternotomy without neck cannula and from right mini thoracothomy reguiring neck cannula insertion into right internal jugular vein.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients undergoing cardiac surgery\n\n 1. conventional sternotomy without neck cannula as planned operating approach\n 2. right minithoracotomy with neck cannula as planned operating approach\n\nExclusion Criteria:\n\n* Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)'}, 'identificationModule': {'nctId': 'NCT02456259', 'briefTitle': 'Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Hradec Kralove'}, 'officialTitle': 'Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion in Patients Undergoing Minimally Invasive Cardiac Surgery', 'orgStudyIdInfo': {'id': '201504S17P'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neck cannula group', 'description': 'Patients in this group are indicated for neck cannula insertion due to tzpu of cardiac surgery (MICS)', 'interventionNames': ['Procedure: Neck cannula insertion']}, {'label': 'Central venous catheter only group', 'description': 'Patients in this group are indicated for central venous catheter insertion only.'}], 'interventions': [{'name': 'Neck cannula insertion', 'type': 'PROCEDURE', 'description': 'Neck cannula insertion is necessary for establishing of cardiopulmonary bypass for Minimally Invasive Cardiac Surgery. It is routine procedure for this type of cardiac surgery.', 'armGroupLabels': ['Neck cannula group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50005', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}], 'overallOfficials': [{'name': 'Zdenek Turek, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Hradec Kralove, Dept. of Anesthesiology, Sokolska 581, Hradec Kralove, 50005, Czech Republic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Hradec Kralove', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph.D.', 'investigatorFullName': 'Zdenek Turek', 'investigatorAffiliation': 'University Hospital Hradec Kralove'}}}}