Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT06473818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac output (CO)', 'timeFrame': '1-60 minutes after spinal anesthesia', 'description': 'Monitoring data'}, {'measure': 'Cardiac index (CI)', 'timeFrame': '1-60 minutes after spinal anesthesia', 'description': 'Monitoring data'}, {'measure': 'Stroke volume (SV)', 'timeFrame': '1-60 minutes after spinal anesthesia', 'description': 'Monitoring data'}, {'measure': 'Stroke volume variation (SVV)', 'timeFrame': '1-60 minutes after spinal anesthesia', 'description': 'Monitoring data'}, {'measure': 'Peripheral vascular resistance', 'timeFrame': '1-60 minutes after spinal anesthesia', 'description': 'Monitoring data'}], 'secondaryOutcomes': [{'measure': 'The incidence of post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia.', 'description': 'Systolic blood pressure (SBP) \\< 80% of the baseline'}, {'measure': 'The incidence of severe post-spinal anesthesia hypotension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\< 60% of the baseline'}, {'measure': 'The incidence of bradycardia', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Heart rate \\< 60 beats/min'}, {'measure': 'The incidence of nausea and vomiting.', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Presence of nausea and vomiting in patients after spinal anesthesia'}, {'measure': 'The incidence of hypertension', 'timeFrame': '1-15 minutes after spinal anesthesia', 'description': 'Systolic blood pressure (SBP) \\>120% of the baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemodynamics']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).', 'detailedDescription': 'The uterine placenta lacks autonomous regulatory ability, thus making maternal cardiac output (CO) the primary source of blood supply. Therefore, monitoring hemodynamics, including maternal CO, is of significant importance and provides guidance for anesthesia decisions such as fluid management and the administration of vasopressors during cesarean section. This study aims to evaluate the consistency of hemodynamic monitoring between NICAP and NICCO technologies (T20A; Chongqing, China) and the traditional pulse wave analysis method (EV1000; USA).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years\n* Primipara or multipara\n* Singleton pregnancy ≥37 weeks\n* American Society of Anesthesiologists physical status classification I to II\n* Scheduled for cesarean section under spinal anesthesia\n\nExclusion Criteria:\n\n* Body height \\< 150 cm\n* Body weight \\> 100 kg or body mass index (BMI) ≥ 40 kg/m2\n* Eclampsia or chronic hypertension or baseline blood pressure ≥140 mmHg\n* Hemoglobin \\< 7g/dl\n* Fetal distress, or known fetal developmental anomaly'}, 'identificationModule': {'nctId': 'NCT06473818', 'briefTitle': 'Non-invasive vs Invasive Cardiac Output Monitoring During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'Non-invasive vs Invasive Cardiac Output Monitoring in Patients Under Spinal Anesthesia During Cesarean Section: a Prospective Observational Study', 'orgStudyIdInfo': {'id': 'Yi Chen-2024-13'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normotensive pregnant women', 'description': 'Singleton pregnancy ≥37 weeks, American Society of Anesthesiologists physical status classification I to II scheduled for cesarean section under spinal anesthesia', 'interventionNames': ['Device: Non-invasive monitoring', 'Device: Invasive monitoring']}], 'interventions': [{'name': 'Non-invasive monitoring', 'type': 'DEVICE', 'otherNames': ['Hemodynamics'], 'description': 'Non-invasive cardiac output monitoring', 'armGroupLabels': ['Normotensive pregnant women']}, {'name': 'Invasive monitoring', 'type': 'DEVICE', 'otherNames': ['hemodynamics'], 'description': 'Invasive cardiac output monitoring', 'armGroupLabels': ['Normotensive pregnant women']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yi Chen, M.D.', 'role': 'CONTACT', 'email': 'czzyxgp@163.com', 'phone': '+86-951-674-3252'}], 'overallOfficials': [{'name': 'Yi Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}