Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:40 PM
Study NCT ID:
NCT07399093
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2025-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-01', 'size': 1023267, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-01T17:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-05', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2026-02-05', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO)', 'timeFrame': '15 minutes post-induction of general anesthesia.', 'description': 'Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Specificity of ultrasound guided Aorto-Caval index (IVC-AO)', 'timeFrame': '15 minutes post-induction of general anesthesia.', 'description': 'Specificity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.'}, {'measure': 'Sensitivity of inferior vena cava (IVC) collapsibility index', 'timeFrame': '15 minutes post-induction of general anesthesia.', 'description': 'Sensitivity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.'}, {'measure': 'Specificity of inferior vena cava (IVC) collapsibility index', 'timeFrame': '15 minutes post-induction of general anesthesia.', 'description': 'Specificity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inferior Vena Cava', 'Collapsibility Index', 'Caval Aorta Index', 'Induction', 'General Anesthesia', 'Craniotomy']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.', 'detailedDescription': 'Post- anesthesia hypotension is of common occurrence, and it hampers tissue perfusion. The magnitude of hypotension is determined by the preoperative volume status, which varies depending on American Society of Anesthesiologists (ASA) physical status, preoperative comorbidities, preoperative medications, and fasting.\n\nGeneral anesthesia causes significant alterations in hemodynamics, as both inhalational and intravenous anesthetics cause bradycardia, decrease in systemic vascular resistance and vasodilatation, and decrease in myocardial contractility, cardiac output and stroke volume, with the absence of surgical stimulus, making induction of anesthesia is the most crucial period at which hypotension occurs.\n\nDue to different definitions of hypotension and diverse patient populations, the effect of volume preload on prevention of hypotension is still controversial. Many recommendations to identified sonographic determination of inferior vena cava (IVC) collapsibility index (IVCCI) as non-invasive, and easy technique for evaluating volume status. Recent guidelines from the American Society of Echocardiography support the general use of IVCCI in assessing volume status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This prospective cohort study will be conducted on 40 patients undergoing craniotomy surgeries at Ain Shams University Hospitals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age from 18 to 40 years.\n* Both sexes.\n* Body Mass Index\\< 40 kg/m².\n* American Society of Anesthesiologists (ASA) physical status I, II.\n* Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.\n* Scheduled for elective craniotomy surgeries before induction of general anesthesia.\n\nExclusion Criteria:\n\n* Current or recent pregnancy (within 3 months).\n* Pre-existing cardiac disease or hypertension.\n* On medications affecting blood pressure \\[Beta-blockers (BBs) and calcium channel blockers (CCBs)\\] .\n* Refusing to undergo the study.'}, 'identificationModule': {'nctId': 'NCT07399093', 'briefTitle': 'Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anesthesia in Patients Undergoing Craniotomy Surgeries', 'orgStudyIdInfo': {'id': 'FMASU MD08/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Patients scheduled for elective craniotomy surgeries before induction of general anesthesia.', 'interventionNames': ['Other: Inferior vena cava collapsibility index', 'Other: Caval Aorta Index']}], 'interventions': [{'name': 'Inferior vena cava collapsibility index', 'type': 'OTHER', 'description': 'Inferior vena cava (IVC) collapsibility index (IVCCI) will be measured.\n\nThe IVCCI is calculated using the following formula:\n\nIVCCI = (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter \\* 100', 'armGroupLabels': ['Study group']}, {'name': 'Caval Aorta Index', 'type': 'OTHER', 'description': 'The Inferior vena cava (IVC): Ao index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole.\n\n\\- The caval aorta index (IVC/Ao) is calculated using the following formula: IVC/Ao index = IVC diameter / aortic diameter.', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Verina F Bekheet, MSc', 'role': 'CONTACT', 'email': 'verina.fares@med.asu.edu.eg', 'phone': '00201098858385'}, {'name': 'Sherif W Sarguios, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Dalia A Mohamed, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Noha M EL-Tobgy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mai M Elhefny, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Verina F Zaref, MSc', 'role': 'CONTACT', 'email': 'verina.fares@med.asu.edu.eg', 'phone': '00201098858385'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Anesthesia, Intensive Care and Pain Management, Ain Shams University, Cairo, Egypt', 'investigatorFullName': 'Verina Fares Zaref Bekheet', 'investigatorAffiliation': 'Ain Shams University'}}}}