Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT04685733
Status:
COMPLETED
Last Update Posted:
2020-12-28
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caretaker Hemodynamic Parameters Validation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-24', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-24', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure performance comparison', 'timeFrame': 'Paired beat-by-beat readings over maximum of 2.5 hours session length', 'description': 'Comparison with arterial catheter-derived blood pressure, guidelines call for meeting a bias of 5 mmHg and a standard deviation of 8 mmHg'}, {'measure': 'Cardiac output performance comparison', 'timeFrame': 'Paired measurements over approximately 1 hour time frame', 'description': 'Comparison with thermo-dilution-based cardiac output, agreement within 1 l/min.'}, {'measure': 'Left ventricular ejection time comparison', 'timeFrame': 'Paired measurements over approximately 1 hour time frame', 'description': 'Comparison with LVET derived from central catheter signal traces, agreement within 20 msec.'}, {'measure': 'Heart rate variability measures comparison', 'timeFrame': 'Paired beat-by-beat readings over maximum of 2.5 hours session length', 'description': 'Comparison with 5 HRV ECG-derived measures, agreement within performance of VitalConnect predicate device'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Blood Pressure', 'Cardiac Output', 'Left Ventricular Ejection Time', 'Heart Rate Variability']}, 'descriptionModule': {'briefSummary': 'Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.', 'detailedDescription': 'Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.\n\nSpecifically, continuous beat-by-beat blood pressure readings against arterial catheter readings, continuous beat-by-beat left ventricular ejection times (LVET) against matching LVETs obtained from central catheters, cardiac output (CO) and stroke volume (SV) measures against thermo-dilution and Fick measurements, and standard HRV parameters based on Caretaker-provided inter-beat intervals (IBI) against the same HRV parameters obtained from ECG-based IBIs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be patients, \\> 18 years of age, who are able and willing to participate and have given written assent', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age, who are able and willing to participate and have given written assent\n\nExclusion Criteria:\n\n* Unable to give written assent\n\n * \\<18 years of age\n * No or poor finger pulse, as determined through visual inspection for ischemic hands'}, 'identificationModule': {'nctId': 'NCT04685733', 'briefTitle': 'Caretaker Hemodynamic Parameters Validation', 'organization': {'class': 'INDUSTRY', 'fullName': 'CareTaker Medical LLC'}, 'officialTitle': 'Caretaker Hemodynamic Parameters Validation', 'orgStudyIdInfo': {'id': 'Hemo_001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Comparison of blood pressure, LVET and CO/SV measures with respective Gold Standards', 'interventionNames': ['Device: Non-invasive hemodynamic measurements']}, {'label': 'Group 2', 'description': 'Comparison of blood pressure and HRV measures with respective Gold Standards', 'interventionNames': ['Device: Non-invasive hemodynamic measurements']}, {'label': 'Group 3', 'description': 'Comparison of blood pressure and CO/SV measures with respective Gold Standards', 'interventionNames': ['Device: Non-invasive hemodynamic measurements']}], 'interventions': [{'name': 'Non-invasive hemodynamic measurements', 'type': 'DEVICE', 'description': 'Non-invasive hemodynamic measurements', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22901', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Caretaker Medical', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Martin Baruch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Caretaker Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CareTaker Medical LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Virginia', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}, {'name': 'Orange County Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}