Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT04180202
Status:
TERMINATED
Last Update Posted:
2024-12-27
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was terminated due to inability of clinical site to enroll sufficient number of subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-invasive pressure indicator', 'timeFrame': '12-72 hours', 'description': "Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 \\< CVP \\< 10 mmHg) or 'high range' (\\>= 10 mmHg)"}], 'secondaryOutcomes': [{'measure': 'Direction of change', 'timeFrame': '12-72 hours', 'description': 'Correlate the directionality of ezCVP change to invasive CVP change over time (i.e., increasing, decreasing or remaining stable).'}, {'measure': 'Correlation with invasive CVP', 'timeFrame': '12-72 hours', 'description': 'Quantify the agreement between ezCVP (non-invasive) and CVP (invasive)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failureļ¼Congestive']}, 'descriptionModule': {'briefSummary': 'Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.', 'detailedDescription': 'The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the El Camino Hospital ICU with central venous catheter.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult age over 18 years.\n2. Arm circumference is 23 cm to 55 cm\n3. Subject will have an existing central venous catheter during their ICU stay\n4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent\n5. Subject or LAR is willing and able to comply with protocol procedures\n\nExclusion Criteria:\n\n1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.\n2. Pregnant (self-reported)\n3. Upper extremity deep venous thrombosis currently being treated\n4. Severe skin disease involving the upper arm(s)\n5. Study investigator may exclude patients based on clinical judgement'}, 'identificationModule': {'nctId': 'NCT04180202', 'briefTitle': 'Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nihon Kohden'}, 'officialTitle': 'Comparison Study of EzCVP and CVP', 'orgStudyIdInfo': {'id': 'CS-014-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Non-invasive central venous pressure', 'type': 'DEVICE', 'otherNames': ['ezCVP', 'CVPni'], 'description': 'Non-invasive method to measure central venous pressure indicator'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Hospital', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Zachary Edmonds, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palo Alto Foundation Medical Group'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only summary data of participants will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon Kohden', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}