Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT03523533
Status:
TERMINATED
Last Update Posted:
2024-03-12
First Post:
2018-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Peripherally Inserted Internal Jugular Catheters: an Observational Study
Sponsor:
Organization:
Raw JSON
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[{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Catheter Placement Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'classes': [{'categories': [{'measurements': [{'value': '5.06', 'spread': '0.78', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'No more than 20 minutes', 'description': 'Elapsed time from first contact of skin prep solution to completely secured/covered catheter', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Location of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'classes': [{'categories': [{'title': "Catheter placed on patient's right side", 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': "Catheter placed on patient's left side", 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'No more than 20 minutes', 'description': "Choice of placement on patient's right or left side", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Depth of Insertion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'No more than 20 minutes', 'description': 'Depth of catheter insertion in target blood vessel', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'No more than 20 minutes', 'description': 'Count of attempts to successfully place catheter', 'unitOfMeasure': 'Attempt', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Catheter-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'classes': [{'categories': [{'title': 'Patients experiencing carotid puncture', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing pneumothorax', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing thrombosis', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing unexpectedly severe pain on placement', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing hematoma', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing injection-site infection', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Patients experiencing none of these complications', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week', 'description': 'Count of subjects experiencing complications that are related to catheter placement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peripherally-inserted Internal Jugular Catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.\n\nAngiocatheter: Placement of angiocatheter in internal jugular vein'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-20', 'size': 197227, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-25T12:27', 'hasProtocol': True}, {'date': '2018-02-20', 'size': 130231, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-08-25T12:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an observational study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Investigator Decision \\& not a clinical trial.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-08', 'studyFirstSubmitDate': '2018-05-01', 'resultsFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-07', 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter Placement Time', 'timeFrame': 'No more than 20 minutes', 'description': 'Elapsed time from first contact of skin prep solution to completely secured/covered catheter'}], 'secondaryOutcomes': [{'measure': 'Location of Insertion', 'timeFrame': 'No more than 20 minutes', 'description': "Choice of placement on patient's right or left side"}, {'measure': 'Depth of Insertion', 'timeFrame': 'No more than 20 minutes', 'description': 'Depth of catheter insertion in target blood vessel'}, {'measure': 'Number of Attempts', 'timeFrame': 'No more than 20 minutes', 'description': 'Count of attempts to successfully place catheter'}, {'measure': 'Number of Participants Experiencing Catheter-related Complications', 'timeFrame': '1 week', 'description': 'Count of subjects experiencing complications that are related to catheter placement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intravenous Drug Usage']}, 'descriptionModule': {'briefSummary': 'This is an observational study intended to characterize the time-to-placement of peripherally-inserted internal jugular (PIJ) catheters in appropriate patients. As secondary outcomes and to ensure patient safety, the investigators will record and evaluate adverse outcomes, but the study is not powered to detect rare events.', 'detailedDescription': 'This is an observational study with one arm. All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein. Approximately 60 subjects will be enrolled.\n\nAfter recruitment and consent, an investigator will place the peripherally-inserted jugular (PIJ) catheters for this study, under ultrasound guidance. Clean technique similar to that used for traditional peripheral intravenous catheters will be used, including chlorhexidine skin preparation, caps, and sterile ultrasound gel with sterile occlusive dressing over the ultrasound transducer. For patients included in this study because of a clinically-determined need for a second IV line, the catheter will be placed after anesthesia induction. Patients included because of difficult IV access will have the PIJ catheter placed prior to induction.\n\nThe size of the angiocatheter will be left to the clinical discretion of the investigator, from among these choices: 18G x 2.5 inches, 16G x 2 inches, or 14G x 2 inches. All angiocatheters will be radiopaque in order to permit visualization in the event of any required imaging. Catheters will be placed with visualization under dynamic ultrasonography using a Sonosite S-Nerve ultrasound machine with 13-6 MHz 25 mm linear array. All catheters and ultrasound components are being used in accordance with their labeling.\n\nThe depth of catheter insertion into the internal jugular vein will be determined, and the catheter will be removed/replaced immediately if it is found to extend less than 1.0 cm into the vessel. If the catheter is removed or replaced, routine care will be followed: pressure will be held until bleeding subsides and the site dressed appropriately (e.g. gauze with tape or adhesive bandage). No more than three attempts will be made before abandoning the effort to place a PIJ catheter.\n\nThe PIJ catheter will be secured as per normal practice, with an adhesive IV securing device and an occlusive bandage placed over both the IV and its securing device.\n\nThe PIJ catheter will be used as usual during surgery. It will not be used for total parenteral nutrition or other continuous nutrient infusions.\n\nIn most cases, the PIJ catheter will be removed as usual before the patient is transferred to the floor, intensive care unit, or discharged home. In some cases, however, an appropriately authorized clinician may determine that the PIJ catheter should remain in place longer. If extended use of the PIJ catheter is indicated, it will be removed when it is either replaced as appropriate by another intravenous line or no longer needed.\n\nProcedural data will be gathered on the day of surgery, and chart review will occur after surgery in order to capture any IV-related complications within the first week that were not immediately apparent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Adult elective-surgery patients at University of New Mexico Hospital main operating rooms, who do not require central venous catheters, and who either:\n\n1. require a second intravenous access line (IV) as determined by the anesthesiologist, \\*or\\*\n2. require a primary IV \\*and\\* are determined by the anesthesiologist to have difficult IV access, defined as two or more failed attempts at peripheral IV placement, in the absence of an indication for a central venous catheter.\n\nExclusion Criteria:\n\n* Infection over the intended peripheral angiocatheter insertion site\n* Cervical spine injury or instability\n* Known abnormal neck anatomy\n* Pregnancy\n* Prisoners\n* Clinical indication for central venous catheter\n* Any pre-existing suspicion for bacteremia\n* Adults unable to consent, as determined by ability to provide consent for surgery'}, 'identificationModule': {'nctId': 'NCT03523533', 'briefTitle': 'Peripherally Inserted Internal Jugular Catheters: an Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Peripherally Inserted Internal Jugular Catheters: an Observational Study', 'orgStudyIdInfo': {'id': '18-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peripherally-inserted internal jugular catheter', 'description': 'All enrolled patients will receive a peripheral angiocatheter in the internal jugular vein, under dynamic ultrasound guidance.', 'interventionNames': ['Procedure: Angiocatheter']}], 'interventions': [{'name': 'Angiocatheter', 'type': 'PROCEDURE', 'description': 'Placement of angiocatheter in internal jugular vein', 'armGroupLabels': ['Peripherally-inserted internal jugular catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87106', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Hospital', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Tony Yen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico Health Sciences Center (HSC)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tony Yen', 'investigatorAffiliation': 'University of New Mexico'}}}}