Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-30 @ 8:11 AM
Study NCT ID:
NCT01861132
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2013-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2013-05-21', 'studyFirstSubmitQcDate': '2013-05-22', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': '15 minutes', 'description': 'Comparison of beat-to-beat data'}], 'secondaryOutcomes': [{'measure': 'Cardiac output', 'timeFrame': '15 minutes', 'description': 'Comparing beat-to-beat data of cardiac output'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pregnancy, cesarean delivery, blood pressure, cardiac output'], 'conditions': ['Hemodynamic Changes in Pregnancy']}, 'referencesModule': {'references': [{'pmid': '32593297', 'type': 'RESULT', 'citation': 'Omenas IN, Tronstad C, Rosseland LA. Accuracy and trending abilities of finger plethysmographic blood pressure and cardiac output compared to invasive measurements during caesarean delivery in healthy women: an observational study. BMC Anesthesiol. 2020 Jun 27;20(1):157. doi: 10.1186/s12871-020-01078-8.'}]}, 'descriptionModule': {'briefSummary': 'Blood pressure and cardiac output can be measured invasively in pregnant women. Non-invasive monitoring devices are desirable, but until now, no equipment has proven validity. This study aims at validating the non-invasive monitoring device NexFin (second generation Finometer) in pregnant women.', 'detailedDescription': 'Validation will be a direct beat-to-beat comparison of data from NexFin and the invasive measurements of blood pressure and calibrated cardiac output as an integrated part of LiDCO Plus. Both comparison of absolute values and the two different devices trending abilities will be analyzed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy singleton pregnancies at term scheduled for cesarean delivery under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy singleton pregnancies at term scheduled for cesarean delivery\n\nExclusion Criteria:\n\n* Twins, or multiple gestation, pre-eclampsia, gestational hypertension\n* Reynaud phenomenon'}, 'identificationModule': {'nctId': 'NCT01861132', 'briefTitle': 'Validation of a Non-invasive Hemodynamic Monitor (NexFin) in Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Validation of Non-invasive Monitoring of Blood Pressure and Cardiac Output in Healthy Pregnant Women During Cesarean Section', 'orgStudyIdInfo': {'id': 'NexValid13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy pregnant women', 'description': 'Healthy pregnant women for C-section under spinal anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head for R&D department', 'investigatorFullName': 'Leiv Arne Rosseland', 'investigatorAffiliation': 'Oslo University Hospital'}}}}