Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05120258
Status:
UNKNOWN
Last Update Posted:
2021-11-15
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of Subclavian / Infraclavicular Axillary Vein Collapsibility Index for detecting Postspinal hypotension', 'timeFrame': '45 min', 'description': 'Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3 to 33% that may result in organ hypoperfusion and ischaemic events. This incidence is higher in pregnant women with a rate of 70%. Measurement of the IVC diameter and its collapsibility index before spinal anaesthesia has been shown to be a good predictive value of the occurrence of PSH. A previous study showed an acceptable correlation between the collapsibility of SCV (SCV-CI) and collapsibility of IVC (IVC-CI) in surgical and intensive care patients. In this study, we measured the preoperative collapsibility index of the SCV or the infraclavicular axillary vein during respiratory variation, and then examined whether these parameters could predict hypotension after spinal anaesthesia in patients undergoing ceserean'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post spinal hypotension, the subclavian vein or infraclavicular axillary vein collapsibility index'], 'conditions': ['Post Spinal Hypotension']}, 'descriptionModule': {'briefSummary': 'Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4).\n\nOne of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7).\n\nIn this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'ASA I-II physical status patients scheduled for cesarean section under spinal anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Spinal anesthesia\n* ceserean operation\n* American Society of Anesthesiologists' (ASA) physical status I-II\n\nExclusion Criteria:\n\n* Patients who underwent cesarean section in emergency conditions\n* Patients who underwent cesarean section under general anesthesia\n* American Society of Anesthesiologists' (ASA) physical status III-IV"}, 'identificationModule': {'nctId': 'NCT05120258', 'acronym': 'Cesarean', 'briefTitle': 'Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations?', 'organization': {'class': 'OTHER', 'fullName': 'Selcuk University'}, 'officialTitle': 'Subclavian / Infraclavicular Axillary Vein Collapsibility Index in Pregnant Patients', 'orgStudyIdInfo': {'id': 'SCV'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emine ASLANLAR, assis. prof.', 'role': 'CONTACT', 'email': 'draslanlar@gmail.com', 'phone': '05556219830'}, {'name': 'Mehmet SARGIN, assoc. prof.', 'role': 'CONTACT', 'email': 'mehmet21sargin@yahoo.com', 'phone': '05322662766'}], 'overallOfficials': [{'name': 'Emine ASLANLAR, assis. prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'selcuk univercity medical faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selcuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'EMİNE ASLANLAR', 'investigatorAffiliation': 'Selcuk University'}}}}