Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-01-07 @ 11:10 AM
Study NCT ID:
NCT06767033
Status:
COMPLETED
Last Update Posted:
2025-01-09
First Post:
2025-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-05', 'studyFirstSubmitDate': '2025-01-05', 'studyFirstSubmitQcDate': '2025-01-05', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Inferior Vena Cava Collapsibility Index', 'Post Spinal Anaesthesia Hypotension', 'Arthroscopic Knee Surgeries'], 'conditions': ['Post Spinal Anaesthesia Hypotension', 'Inferior Vena Cava Collapsibility Index']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.', 'detailedDescription': 'Prospective Cohort Study conducted in Ain Shams University Hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.\n* Both Sexes.\n* Aged 30 to 60 years.\n* Body mass index \\<35 kg/m2\n\nExclusion Criteria:\n\n* Patients' refusal of procedure or participation in the study.\n* Patients with contraindication to spinal anaesthesia.\n* Patients with severe cardiovascular or pulmonary disease.\n* Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg)."}, 'identificationModule': {'nctId': 'NCT06767033', 'briefTitle': 'Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.', 'orgStudyIdInfo': {'id': 'FMASU MS89/2024'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound Guided Inferior Vena Cava Collapsibility Index Assessment', 'type': 'DEVICE', 'description': 'Before spinal anaesthesia, inferior vena cava collapsibility index was measured for all patients using Ultrasound device.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}