Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-11 @ 10:57 PM
Study NCT ID:
NCT06087250
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Artery Corrected Flow Time and Fluid Responsiveness in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-10-12', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'carotid corrected flow time (cFT)', 'timeFrame': '1 hour', 'description': 'the ability ofc FT to predict fluid responsiveness'}], 'secondaryOutcomes': [{'measure': 'cutt-of value of cFT', 'timeFrame': '1 hour', 'description': 'the cutt-of value of cFT to predict fluid responsiveness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fluid responsiveness', 'carotid blood flow', 'carotid corrected flow time'], 'conditions': ['Fluid Responsiveness', 'Common Carotid Artery']}, 'descriptionModule': {'briefSummary': 'Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.', 'detailedDescription': "Doppler ultrasound of the common carotid artery has begun to be used as a potential non-invasive tool for assessing hemodynamic status. Its non-invasive nature, ability to be applied independently of the patient's position, ease of application due to the superficial location of the carotid artery, and resistance to intrathoracic pressure changes are among its advantages. Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. Additionally, the velocity time integral (VTI) measuring blood flow through the carotid artery during systole, when multiplied by the cross-sectional area of the carotid artery, allows for the determination of flow within the carotid artery. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'geriatric patient (older than 65 years of age) having surgery under general anesthesia', 'genderDescription': 'older than 65 years of age', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* geriatric patient (older than 65 years of age) having surgery under general anesthesia\n\nExclusion Criteria:\n\n* Common carotid artery stenosis, common carotid artery disease'}, 'identificationModule': {'nctId': 'NCT06087250', 'briefTitle': 'Carotid Artery Corrected Flow Time and Fluid Responsiveness in Geriatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Reliability of Carotid Artery Corrected Flow Time Predicting Fluid Responsiveness in Geriatric Patients.', 'orgStudyIdInfo': {'id': '2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fluid responsive', 'description': 'A 15% increase in cardiac output following a fluid challenge ( 6ml/kg crystalloid solution infusion in 30 min).\n\nCarotid corrected flow time measured before and after fluid challenge by ultrasound.'}, {'label': 'Fluid non-responsive', 'description': 'Failure of 15% increase in cardiac output following a fluid challenge ( 6ml/kg crystalloid solution infusion in 30 min).\n\nCarotid corrected flow time measured before and after fluid challenge by ultrasound.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Prof, M.D', 'investigatorFullName': 'Beliz Bilgili', 'investigatorAffiliation': 'Marmara University'}}}}