Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03056859
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2017-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compass Device CVC Trial
Sponsor:
Organization:
Raw JSON
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Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes', 'description': 'Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Arterial Puncture Incidence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 minutes', 'description': 'Incidence of arterial puncture', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Implement Used at Time of Arterial Puncture, if Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer'}], 'timeFrame': '15 minutes', 'description': 'If arterial puncture occurred, list catheterization implement being manipulated at the time', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no arterial punctures observed during the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrolled Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '39.6', 'groupId': 'BG000', 'lowerLimit': '36.2', 'upperLimit': '43.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-02-14', 'size': 362780, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-25T10:16', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2017-02-14', 'resultsFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-25', 'studyFirstPostDateStruct': {'date': '2017-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operator Satisfaction', 'timeFrame': '15 minutes', 'description': 'Operator satisfaction (0-10 scale; 0=totally dissatisfied, 10=totally satisfied)'}], 'secondaryOutcomes': [{'measure': 'Arterial Puncture Incidence', 'timeFrame': '15 minutes', 'description': 'Incidence of arterial puncture'}, {'measure': 'Implement Used at Time of Arterial Puncture, if Any', 'timeFrame': '15 minutes', 'description': 'If arterial puncture occurred, list catheterization implement being manipulated at the time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Operator satisfaction with device'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.', 'detailedDescription': "Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting at University of New Mexico main/adult operating rooms who require central venous catheter (CVC) placement for perioperative care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥35\n\nExclusion Criteria:\n\n* Pregnant women\n* Adults unable to consent\n* Non-English speakers\n* Prisoners'}, 'identificationModule': {'nctId': 'NCT03056859', 'briefTitle': 'Compass Device CVC Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Central Venous Catheterization in Obese Patients With Compass Device', 'orgStudyIdInfo': {'id': 'Compass Device Trial'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Enrolled Patients', 'description': 'Procedure: Central venous catheter placement with extravascular blood pressure transducer', 'interventionNames': ['Device: Extravascular blood pressure transducer']}], 'interventions': [{'name': 'Extravascular blood pressure transducer', 'type': 'DEVICE', 'otherNames': ['Compass Vascular Access'], 'description': 'Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions', 'armGroupLabels': ['Enrolled Patients']}]}, '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': 'Neal Gerstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Deidentified study data may be shared with other researchers, pending final decision by study PI and sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centurion Medical Products', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Neal Gerstein', 'investigatorAffiliation': 'University of New Mexico'}}}}