Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-01-05 @ 2:38 PM
Study NCT ID:
NCT01732133
Status:
COMPLETED
Last Update Posted:
2017-04-11
First Post:
2012-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2012-11-19', 'studyFirstSubmitQcDate': '2012-11-21', 'lastUpdatePostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison between Nexfin and intermittent measurements of blood pressure', 'timeFrame': 'two years', 'description': 'Bland and Altman analysis (bias and limits of agreement). Analysis concerns data from intrathecal injection to childbirth'}], 'secondaryOutcomes': [{'measure': 'Area under the curve between both measurements', 'timeFrame': 'two years', 'description': 'Analysis concerns data from intrathecal injection to childbirth'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypotension', 'Cesarean delivery'], 'conditions': ['Hypotension']}, 'referencesModule': {'references': [{'pmid': '34087863', 'type': 'DERIVED', 'citation': 'Bobet M, Joachim J, Gayat E, Bonnet A, Sievert K, Barnichon C, Fischler M, Le Guen M. Blood pressure measurement during cesarean delivery: Evaluation of a beat-to-beat noninvasive device (NexfinTM). Medicine (Baltimore). 2021 Jun 4;100(22):e26129. doi: 10.1097/MD.0000000000026129.'}]}, 'descriptionModule': {'briefSummary': 'Hypotension after spinal anesthesia for cesarean delivery occurs frequently. Oscillometric measurement gives intermittent informations. Nexfin, a continuous noninvasive device, could help to detect hypotension.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients undergoing elective cesarean delivery performed under spinal anesthesia\n\nExclusion Criteria:\n\n* patients with a heart rhythm disorder, Raynaud's disease or a history of vascular surgery of the upper limb"}, 'identificationModule': {'nctId': 'NCT01732133', 'acronym': 'NEXFIN-CESAR', 'briefTitle': 'Evaluation of NEXFIN During Cesarean Delivery to Detect Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Evaluation of the System NEXFIN for Continuous and Non-invasive Measure of the Blood Pressure During Cesarean Delivery Practised Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': '2012/27'}, 'secondaryIdInfos': [{'id': '2012-A00811-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Measurement of arterial pressure', 'interventionNames': ['Device: Nexfin']}], 'interventions': [{'name': 'Nexfin', 'type': 'DEVICE', 'otherNames': ['Continuous measurement of arterial pressure using Nexfin'], 'armGroupLabels': ['Measurement of arterial pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92300', 'city': 'Levallois-Perret', 'country': 'France', 'facility': 'Institut Hospitalier Franco-Britannique', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '92151', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}], 'overallOfficials': [{'name': 'Marc Fischler, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Foch'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}