Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-29 @ 1:32 AM
Study NCT ID:
NCT06105866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-04
First Post:
2023-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-01', 'studyFirstSubmitDate': '2023-10-19', 'studyFirstSubmitQcDate': '2023-10-26', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The TAPSE value is related to volume', 'timeFrame': 'Patients who apply to our hospital for surgery within 6 months will be included in our study. Preoperative TAPSE measurements will be taken from the patients twice, first during admission and immediately before the operation', 'description': "We will measure FAC, S' velocity, TAPSE, and Myocardial Performance Index (MPI) derived from TDI to evaluate Right Ventricular (RV) systolic functions. To assess the RV diastolic function, we will measure Tricuspid E and A wave velocities, E/A ratio, and E' velocity. TAPSE will be calculated by placing an M-mode cursor along the Tricuspid Annulus and measuring the longitudinal excursion during peak systole"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tricuspid Annular Plane Systolic Excursion', 'Preoperative Fasting', 'Right ventricular functions'], 'conditions': ['The Relationship Between TAPSE Value and Volume']}, 'referencesModule': {'references': [{'pmid': '20113911', 'type': 'BACKGROUND', 'citation': 'Lee S, Kamdar F, Madlon-Kay R, Boyle A, Colvin-Adams M, Pritzker M, John R. Effects of the HeartMate II continuous-flow left ventricular assist device on right ventricular function. J Heart Lung Transplant. 2010 Feb;29(2):209-15. doi: 10.1016/j.healun.2009.11.599.'}, {'pmid': '35449700', 'type': 'BACKGROUND', 'citation': 'Gullupinar B, Saglam C, Koran S, Turhan A, Unluer EE. The role of mitral annular plane systolic excursion in prediction of acute blood loss in healthy voluntary blood donors. J Ultrason. 2022 Feb 8;22(88):e33-e38. doi: 10.15557/JoU.2022.0006. eCollection 2022 Mar.'}, {'pmid': '30081914', 'type': 'BACKGROUND', 'citation': 'Zhang H, Wang X, Chen X, Zhang Q, Liu D. Tricuspid annular plane systolic excursion and central venous pressure in mechanically ventilated critically ill patients. Cardiovasc Ultrasound. 2018 Aug 7;16(1):11. doi: 10.1186/s12947-018-0130-2.'}, {'pmid': '33879320', 'type': 'BACKGROUND', 'citation': 'Newman K, Wilson R, Roberts JM, Mayo JR, Mohamed Ali AA, Brunner N, Sedlic A. Tricuspid annular plane systolic excursion for the evaluation of right ventricular function in functional cardiac CT compared to MRI. Clin Radiol. 2021 Aug;76(8):628.e1-628.e7. doi: 10.1016/j.crad.2021.02.018. Epub 2021 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'The aim of our study is to try to establish a relationship between preoperative fasting-related volume changes and tricuspid annular plane systolic excursion (TAPSE), and to determine whether there are changes in right ventricular functions due to preoperative fasting.', 'detailedDescription': 'TAPSE (Tricuspid Annular Plane Systolic Excursion) is a parameter that easily measures apex-base shortening and provides specific information about global right ventricular (RV) function. It is less dependent on optimal image quality and serves as an easily measurable criterion compared to other RV function measurements. In this study, one day before the operation, transthoracic echocardiography (TTE) will be conducted on fasting patients, and if the preoperative fasting duration is appropriate on the day of the surgery, TTE measurements will be repeated and recorded. The study aims to evaluate the relationship between TAPSE and volume and determine whether there are any changes in right ventricular functions due to preoperative fasting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for surgery who have applied to Adnan Menderes University Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-2-3\n* The patient must be between 18 and 75 years old.\n* Perioperative hydration has not been administered.\n* Preoperative sedatives have not been given.\n* There should be no known heart disease.\n\nExclusion Criteria:\n\n* The patient being pregnant\n* Post-cardiac surgery\n* Severe pulmonary hypertension\n* Severe valve disease\n* Hypertrophic or dilated cardiomyopathy\n* Presence of acute myocardial infarction\n* Non-sinus rhythm'}, 'identificationModule': {'nctId': 'NCT06105866', 'acronym': '(TAPSE)', 'briefTitle': 'Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Relationship of Preoperative Fasting With Tricuspid Annular Plane Systolic Excursion (TAPSE)', 'orgStudyIdInfo': {'id': 'NCT093509350935'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients without Cardiac Disease', 'description': 'Patients between the ages of 18-75 with sinus rhythm, and without valvular disease, pulmonary hypertension, acute myocardial infarction, dilated, and hypertrophic cardiomyopathy will be included in the study.', 'interventionNames': ['Diagnostic Test: Tricuspid Annular Plane Systolic Excursion']}], 'interventions': [{'name': 'Tricuspid Annular Plane Systolic Excursion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transthoracic echocardiography will be performed on patients during hospitalization and preoperatively to investigate the relationship between preoperative fasting and right ventricular functions. This will be examined by looking at TAPSE', 'armGroupLabels': ['Patients without Cardiac Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09010', 'city': 'Aydin', 'state': 'Zafer', 'country': 'Turkey (Türkiye)', 'facility': 'Sevil Gulasti', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'At the end of the study, the results of the statistical analysis of all collected data will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'ferdi gülaştı', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}