Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-20 @ 10:37 AM
Study NCT ID:
NCT06479512
Status:
RECRUITING
Last Update Posted:
2024-08-15
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000081282', 'term': 'Perfusion Index'}], 'ancestors': [{'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2024-06-24', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'caval aorta index for predicting hypotension in the elderly', 'timeFrame': '1 hour', 'description': 'to determine the threshold value for the caval aorta index in determining hypotension using logistic regression analysis'}], 'secondaryOutcomes': [{'measure': 'perfusion index for predicting hypotension in the elderly', 'timeFrame': '1 hour', 'description': 'to determine the threshold value for baseline perfusion index in determining hypotension using logistic regression analysis'}, {'measure': 'systolic blood pressure', 'timeFrame': '1 hour', 'description': 'recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'diastolic blood pressure', 'timeFrame': '1 hour', 'description': 'recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'mean arterial pressure', 'timeFrame': '1 hour', 'description': 'recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'hearth rate', 'timeFrame': '1 hour', 'description': 'recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'perfusion index', 'timeFrame': '1 hour', 'description': 'recorded preoperatively and in the operating room every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'oxygen saturation', 'timeFrame': '1 hour', 'description': 'recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation'}, {'measure': 'bromage scale motor blocage score', 'timeFrame': '1 hour', 'description': 'bromage scale score is a score between 0 and 3. bromage 0 means full movement of the leg and knee, bromage 3 means full motor blockade of the legs. the time to reach bromage 3 will be recorded'}, {'measure': 'T10 dermatome', 'timeFrame': '1 hour', 'description': 'time to reach T10 dermatome level'}, {'measure': 'dermatomal level', 'timeFrame': '1 hour', 'description': 'the highest dermatome level achieved with spinal anesthesia'}, {'measure': 'use ephedrine', 'timeFrame': '1 hour', 'description': 'dose of ephedrine used'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'caval aorta index', 'perfusion index', 'orthopedic surgery', 'elderly patients'], 'conditions': ['Anesthesia, Spinal']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to predict hypotension by using caval aorta index and perfusion index in elderly patients who may develop hypotension after spinal anesthesia.', 'detailedDescription': 'The study will include 190 patients over 60 years of age who are planned to undergo elective lower extremity surgery in the supine position with spinal anaesthesia. This study is planned as a single-centre prospective observational study. All patients planned to be included in the study will be fasted according to the standard protocol. Age, height, body weight, body mass index, gender, type of surgery, systemic disease, preoperative heart rate (HR), noninvasive systolic (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and peripheral oxygen saturation (SpO₂) will be measured and noted in the waiting area before entering the operating room. For the initial perfusion index (PI) value, PI measurement will be taken 3 times at 5 minutes intervals with a probe to be attached to the same finger and the average will be recorded as the initial PI value. To measure the IVC diameter, the maximum internal AP diameter of the IVC will be measured 3 times in M-mode during expiration and the mean will be taken. The maximum internal AP diameter of the abdominal aorta will be measured three times during systole and the mean will be recorded as the aortic diameter.The study will be explained to all patients participating in the study and informed consent will be obtained from the patients.Routine preoperative preparations and monitoring of the patients admitted to the operating room will be performed.Spinal anaesthesia will be performed through L3-4 or L4-5 intervertebral spaces in the sitting position.Depending on the nature of the patient and the type of surgery, an appropriate dose of 0.5% hyperbaric bupivacaine will be injected intrathecally to provide adequate sensory block.The patient will be immediately placed in the supine position.The level of sensory blockade will be evaluated at the end of the appropriate time. heart rate, systolic, diastolic blood pressure, mean arterial pressure, oxygen saturation and PI will be recorded every 2 minutes for the first 15 minutes, then every 5 minutes until the 30th minute, then every 10 minutes until the 60th minute and at the end of the operation.Hypotension after spinal anaesthesia will be defined as SDB less than 90 mmHg, a fall in SDB by more than 30% from the preoperative baseline value or an OAB less than 60 mmHg.Patients will be divided into two groups as patients with and without hypotension after spinal anaesthesia. Demographic data (age, gender, comorbidity, etc.), caval-aorta index and PI will be analysed for differences between the groups.\n\nThe primary aim of the study was to evaluate the ability of caval-aorta index and PI to predict post-spinal hypotension in elderly patients between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '60 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients over 60 years of age who will undergo elective lower extremity surgery in supine position admitted to ankara city hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology(ASA) I-II-III score\n* Patients over 60 years\n* Elective surgeries\n* Surgeries in supine position\n\nExclusion Criteria:\n\n* Patient refusal to participate in the study\n* The patient will undergo emergency surgery\n* Contraindication to spinal anaesthesia\n* Planning unilateral spinal anaesthesia\n* Failure of spinal anaesthesia\n* Body mass index above 30kg/m2\n* Presence of preoperative hypotension (SBP\\<90mmHg or MAP\\<60mmHg)\n* The patient has valvular disease and arrhythmia impairing haemodynamics\n* Presence of neuropsychiatric disorders that make communication difficult\n* Presence of abdominal hernia'}, 'identificationModule': {'nctId': 'NCT06479512', 'briefTitle': 'Caval-aorta Index and Perfusion Index on Predict Hypotension After Spinal Anaesthesia in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Can Caval-aorta Index and Perfusion Index Predict Hypotension After Spinal Anaesthesia in Elderly Patients Undergoing Lower Extremity Surgery?', 'orgStudyIdInfo': {'id': 'spinal-induced hypotension'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with spinal induced hypotension', 'description': 'patients with hypotension after spinal anesthesia (SBP less than 90 mmHg, a decrease in SBP by more than 30% from the preoperative baseline value, or an MAP below 60 mmHg)', 'interventionNames': ['Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index']}, {'label': 'patients without spinal induced hypotension', 'description': 'patients without spinal induced hypotension', 'interventionNames': ['Device: ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index']}], 'interventions': [{'name': 'ultrasonography to measure the index of the caval aorta and non-invasive pulse oximetry for perfusion index', 'type': 'DEVICE', 'description': 'Inferior vena cava and aortic diameter measurements will be made by ultrasonography and perfusion index determination using non-invasive pulse oximetry', 'armGroupLabels': ['patients with spinal induced hypotension', 'patients without spinal induced hypotension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'state': 'Ankara, Çankaya, Turkey, 06800', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma K Kavak Akelma, Prof', 'role': 'CONTACT', 'email': 'fatmakavak@yahoo.com', 'phone': '05327079113'}], 'facility': 'Ankara Bilkent City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Fatma K Akelma', 'role': 'CONTACT', 'email': 'fatmakavak@yahoo.com', 'phone': '05327079113'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'anesthesiology and reanimation associate professor', 'investigatorFullName': 'Fatma Kavak Akelma', 'investigatorAffiliation': 'Ankara Yildirim Beyazıt University'}}}}