Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT01896206
Status:
COMPLETED
Last Update Posted:
2015-02-27
First Post:
2013-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CNAP Accuracy in the Bariatric Surgery Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Joseph.Tobias@nationwidechildrens.org', 'phone': '6147224200', 'title': 'Joseph D. Tobias, MD', 'organization': "Nationwide Children's Hospital"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CNAP Monitor', 'description': 'Subjects undergoing bariatric surgery and monitored using the CNAP monitor.\n\nCNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CNAP Monitor', 'description': 'Subjects undergoing bariatric surgery and monitored using the CNAP monitor.\n\nCNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Participants will be followed for the duration of surgery, an expected average of 2 hours.', 'description': 'To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The initial study cohort included 21 patients; however, the finger cuff was expired in 1 patient, resulting in no data collection, and the data from 2 other patients were lost in the download to the electronic medical record system.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CNAP Monitor', 'description': 'Subjects undergoing bariatric surgery and monitored using the CNAP monitor.\n\nCNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CNAP Monitor', 'description': 'Subjects undergoing bariatric surgery and monitored using the CNAP monitor.\n\nCNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '17.55', 'spread': '2.53', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-25', 'studyFirstSubmitDate': '2013-06-27', 'resultsFirstSubmitDate': '2015-02-03', 'studyFirstSubmitQcDate': '2013-07-08', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-25', 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Absolute Difference in Mean Arterial Pressure Between the Arterial Catheter and the CNAP.', 'timeFrame': 'Participants will be followed for the duration of surgery, an expected average of 2 hours.', 'description': 'To avoid biasing the data, the absolute, not directional, difference was used. For example, if the reading from the CNAP device was 10 mmHg above or below the reading from the AC, a value of 10 mmHg was used, not -10 or +10 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery']}, 'descriptionModule': {'briefSummary': 'This study will compare accuracy of a newly developed monitor for continuous non-invasive blood pressure monitoring (CNAP™ Monitor 500; CNSystems Medizintechnik AG, Graz, Austria) that provides beat-to-beat BP readings with two of the current and more commonly used intermittently oscillometric non-invasive blood pressure device (NIBP), and the invasive arterial line (IBP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are scheduled for laparoscopic bariatric surgery for the treatment of obesity\n* Patients in whom an indwelling arterial cannula will be placed for the surgical procedure\n\nExclusion Criteria:\n\n* Patients with history of a peripheral neurologic or neuropathic disorder\n* Patients in whom an invasive arterial cannula cannot be placed\n* Patients with vascular implants at the sites of non-invasive blood pressure measurement (fingers and upper arm of the examined arm)\n* Edematous patients'}, 'identificationModule': {'nctId': 'NCT01896206', 'briefTitle': 'CNAP Accuracy in the Bariatric Surgery Population', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'orgStudyIdInfo': {'id': 'IRB12-00808'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CNAP monitor', 'description': 'Subjects undergoing bariatric surgery and monitored using the CNAP monitor.', 'interventionNames': ['Device: CNAP monitor']}], 'interventions': [{'name': 'CNAP monitor', 'type': 'DEVICE', 'description': 'Patients undergoing bariatric surgery and being monitored using the CNAP monitor.', 'armGroupLabels': ['CNAP monitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Joseph D Tobias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman - Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}