Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01485120
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2011-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
Sponsor:
Organization:
Raw JSON
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Data obtained from the cuff used either the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.'}], 'classes': [{'title': 'Systolic value', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '6.00', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic value', 'categories': [{'measurements': [{'value': '1.39', 'spread': '3.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours', 'description': 'NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperStat algorithm for output.'}, {'type': 'PRIMARY', 'title': 'Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Blood Pressure Monitoring', 'description': 'Participants with blood pressure monitored using invasive and non-invasive methods.'}], 'classes': [{'title': 'Systolic value', 'categories': [{'measurements': [{'value': '0.68', 'spread': '7.10', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic value', 'categories': [{'measurements': [{'value': '0.42', 'spread': '3.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 2 hours', 'description': 'NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the Classic NIBP algorithm for output.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Blood Pressure Monitoring', 'description': 'Participants with blood pressure monitored using invasive and non-invasive methods. Blood pressure monitoring will take place with both devices simultaneously. The invasive "gold standard" device is a radial arterial catheter connected to the DASH 4000, while the non-invasive device is the Soft-Cuf connected to the DASH 4000 Patient Bedside Monitor with SuperSTAT NIBP software, or same with the Classic NIBP algorithm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Blood Pressure Monitoring', 'description': 'Blood Pressure Monitoring using two methods: invasive radial line insertion and non-invasive blood pressure cuff'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '11.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', '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': '14', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-06', 'studyFirstSubmitDate': '2011-12-01', 'resultsFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2011-12-02', 'lastUpdatePostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-06', 'studyFirstPostDateStruct': {'date': '2011-12-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading', 'timeFrame': 'Approximately 2 hours', 'description': 'NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).'}, {'measure': 'Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading', 'timeFrame': 'Approximately 2 hours', 'description': 'NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood pressure (low, normal, high)'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.', 'detailedDescription': 'Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide written informed consent or have a legally authorized representative provide written informed consent\n* Any volunteer subjects ≥ 18 years of age\n* Subject must have the presence of normal sinus rhythm on ECG\n* Subject will return for follow-up visit from 5 days to 8 days after study procedure\n\nExclusion Criteria:\n\n* Any subject who is unable to provide written informed consent\n* Any subject with the presence of peripheral vascular disease in either arm\n* Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.\n* Any subject who cannot tolerate 21 repeated BP measurements\n* Any subjects with clotting or bleeding disorders\n* Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)\n* Any subject who is unable to have arterial line placed in the radial artery\n* Any subject that cannot tolerate 4 fast flushes for the frequency response\n* Any female subjects pregnant or lactating\n* Any subject that has previously participated in this study\n* Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit'}, 'identificationModule': {'nctId': 'NCT01485120', 'briefTitle': 'Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure', 'organization': {'class': 'INDUSTRY', 'fullName': 'GE Healthcare'}, 'officialTitle': 'Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure', 'orgStudyIdInfo': {'id': '118.02-2011-GES-0007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Blood Pressure monitoring', 'description': 'Blood Pressure (BP) monitoring using invasive arterial insertion as a standard reference, and an investigational, non-invasive blood pressure (NIBP) monitoring cuff. Data obtained from the cuff used the SuperSTAT NIBP algorithm and the Classic NIBP algorithm for output.', 'interventionNames': ['Device: BP monitoring using two methods']}], 'interventions': [{'name': 'BP monitoring using two methods', 'type': 'DEVICE', 'description': 'BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.', 'armGroupLabels': ['Blood Pressure monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80027', 'city': 'Louisville', 'state': 'Colorado', 'country': 'United States', 'facility': 'Clinimark', 'geoPoint': {'lat': 39.97776, 'lon': -105.13193}}], 'overallOfficials': [{'name': 'David Ransom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinimark, LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GE Healthcare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}