Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-01-07 @ 2:00 PM
Study NCT ID:
NCT03130660
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2017-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patient to be randomized to two groups'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2017-04-22', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to insertion', 'timeFrame': '15 minutes', 'description': 'time from skin puncture to insertion of guidewire'}], 'secondaryOutcomes': [{'measure': 'Total Procedure time', 'timeFrame': '15 minutes', 'description': 'Time from when Ultrasound scan was started to complete suturing of the CVC line.'}, {'measure': 'Number of needle sticks', 'timeFrame': '15 minutes', 'description': 'Number of time punctures were done in the skin'}, {'measure': 'Complications', 'timeFrame': '48 hours', 'description': 'hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['central line', 'Central Line Complication'], 'conditions': ['Ultrasonography', 'Central Line Complication']}, 'descriptionModule': {'briefSummary': 'We plan to compare single person short axis view with two person long axis view', 'detailedDescription': 'Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.\n\nMethodology:\n\nInclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.\n\nExclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.\n\nDefinition:\n\n1. Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.\n2. Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.\n3. Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.\n\nAll the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.\n\nStatistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient getting admitted to ICU and requiring central venous cannulations.\n\nExclusion Criteria:\n\n* Lack of consent'}, 'identificationModule': {'nctId': 'NCT03130660', 'briefTitle': 'Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Medical Sciences and SUM Hospital'}, 'officialTitle': 'Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.', 'orgStudyIdInfo': {'id': 'DMR/IMS.SH/SOA/170022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short Axis Ultrasonography', 'description': 'one person does both ultrasound and line insertion', 'interventionNames': ['Device: Ultrasonography']}, {'type': 'EXPERIMENTAL', 'label': 'Long Axis Ultrasonography', 'description': 'one person does ultrasound and another inserts the central line', 'interventionNames': ['Device: Ultrasonography']}], 'interventions': [{'name': 'Ultrasonography', 'type': 'DEVICE', 'description': 'Ultrasound guidance for central line', 'armGroupLabels': ['Long Axis Ultrasonography', 'Short Axis Ultrasonography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751007', 'city': 'Bhubaneswar', 'state': 'Odisha', 'country': 'India', 'facility': 'IMS and SUM Hospital', 'geoPoint': {'lat': 20.27241, 'lon': 85.83385}}], 'overallOfficials': [{'name': 'Arun Rath, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IMS and Sum hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We havent decided yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Medical Sciences and SUM Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shakti Bedanta Mishra', 'investigatorAffiliation': 'Institute of Medical Sciences and SUM Hospital'}}}}