Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-25 @ 8:00 PM
Study NCT ID:
NCT01680666
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mbruzoni@stanford.edu', 'phone': '650-723-6439', 'title': 'Matias Bruzoni, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 410 seconds', 'description': 'Per protocol, procedure-related complications were reported as adverse events', 'eventGroups': [{'id': 'EG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.", 'otherNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.", 'otherNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Hemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma (nonexpanding)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial puncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Success of Central Venous Cannulation at First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Landmark Technique', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'OG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with successful central venous cannulation at first attempt is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Success of Central Venous Cannulation Within First Three Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'OG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with successful central venous cannulation within the first three attempts is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Arterial Punctures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'OG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with arterial punctures is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patients With Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'OG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Successful Cannulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'OG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '410'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '220'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 410 seconds', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'FG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Landmark Guided', 'description': "In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon's preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air."}, {'id': 'BG001', 'title': 'Ultrasound Guided', 'description': "In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon's preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '18'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2012-08-28', 'resultsFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2012-09-04', 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-26', 'studyFirstPostDateStruct': {'date': '2012-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of Central Venous Cannulation at First Attempt', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with successful central venous cannulation at first attempt is reported.'}], 'secondaryOutcomes': [{'measure': 'Success of Central Venous Cannulation Within First Three Attempts', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with successful central venous cannulation within the first three attempts is reported.'}, {'measure': 'Patients With Arterial Punctures', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with arterial punctures is presented.'}, {'measure': 'Patients With Complications', 'timeFrame': 'Up to 410 seconds', 'description': 'The count (%) of patients with complications (including hemothorax, hematoma, pneumothorax, or catheter malposition) is presented.'}, {'measure': 'Time to Successful Cannulation', 'timeFrame': 'Up to 410 seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Need for Central Venous Access']}, 'referencesModule': {'references': [{'pmid': '23478546', 'type': 'RESULT', 'citation': 'Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia\n\nExclusion Criteria:\n\n* Preoperative proof of non-patency of central veins\n* coagulopathy\n* access site surgeon'}, 'identificationModule': {'nctId': 'NCT01680666', 'briefTitle': 'A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'A Prospective Randomized Trial of Ultrasound Versus Landmark Guided Central Venous Access in Children', 'orgStudyIdInfo': {'id': 'IRB-8943'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'landmark guided', 'description': 'central line placement', 'interventionNames': ['Procedure: central line placement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound guided', 'description': 'central line placement', 'interventionNames': ['Procedure: central line placement', 'Device: Ultrasound']}], 'interventions': [{'name': 'central line placement', 'type': 'PROCEDURE', 'description': 'central line placement', 'armGroupLabels': ['landmark guided', 'ultrasound guided']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'otherNames': ['Sonosite, Bothel, WA', 'Aloka, Wallingford, CT'], 'description': 'Ultrasound guided central venous access', 'armGroupLabels': ['ultrasound guided']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Matias Bruzoni', 'investigatorAffiliation': 'Stanford University'}}}}