Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT07042893
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Pulmonary Resection on Right Ventricular Function
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': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2025-06-20', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Echocardiographic Assessment: TAPSE/PAP Ratio', 'timeFrame': '24 hours preoperatively and on postoperative day 2', 'description': 'Patients will be evaluated by echocardiography 24 hours before surgery and on the second postoperative day, and the TAPSE/PAP ratio will be recorded in mm/mmHg.'}, {'measure': 'Echocardiographic Assessment: Tricuspid Annular Plane Systolic Excursion (TAPSE)', 'timeFrame': '24 hours preoperatively and on postoperative day 2', 'description': 'Patients will be evaluated by echocardiography 24 hours preoperatively and on postoperative day 2, and TAPSE will be recorded in millimeters (mm).'}, {'measure': 'Echocardiographic Assessment: Pulmonary Artery Pressure (PAP)', 'timeFrame': '24 hours preoperatively and on postoperative day 2', 'description': 'Patients will be evaluated by echocardiography 24 hours before surgery and on the second postoperative day, and PAP will be recorded in millimeters of mercury (mmHg).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulmonary resection', 'right ventricular function', 'echocardiography', 'cardiothoracic anesthesia'], 'conditions': ['Pulmonary Resection', 'Right Ventricular Function', 'Echocardiography', 'Cardiothoracic Anesthesia']}, 'descriptionModule': {'briefSummary': 'Lung resection is associated with high postoperative morbidity and mortality and leads to a significant long-term decrease in functional capacity, particularly due to cardiorespiratory complications. One of the contributing factors to this functional decline is the postoperative reduction in right ventricular function. Due to the anatomical proximity and interactions, right ventricular function is evaluated by echocardiography following lung resection. The pulmonary artery pressure (PAP)/tricuspid annular plane systolic excursion (TAPSE) ratio is a parameter that provides a more comprehensive assessment of right heart function by evaluating both right ventricular systolic function and pulmonary artery pressure. In this study, investigators aimed to evaluate changes in right heart function by performing preoperative and postoperative echocardiographic assessments in participants undergoing lung resection, focusing on PAP/TAPSE ratios.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 to 80 years scheduled to undergo lung resection surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 to 80 years\n\nASA classification I-III\n\nPatients scheduled to undergo lung resection in thoracic surgery\n\nExclusion Criteria:\n\nPatients with arrhythmia\n\nPatients using antiarrhythmic drugs\n\nPatients with renal failure requiring hemodialysis\n\nPatients with a history of previous lung surgery\n\nPatients with valvular heart disease\n\nPatients with a history of angina pectoris or myocardial infarction within the past month\n\nPatients with FEV1/FVC ratio below 60%'}, 'identificationModule': {'nctId': 'NCT07042893', 'briefTitle': 'Effects of Pulmonary Resection on Right Ventricular Function', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': 'Echocardiographic Assessment of Right Ventricular Function After Pulmonary Resection', 'orgStudyIdInfo': {'id': '2024 - 1160'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'In this study, a single group (Group 1) will be defined, and patients scheduled for lung resection who agree to participate will be included.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06500', 'city': 'Ankara', 'state': 'yenimahalle', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'GAZI UNIVERSITY FACULTY OF MEDICINE', 'role': 'CONTACT', 'phone': '03122025369'}], 'facility': 'Gazi University Faculty of Medicine, Ankara', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Çağrı Özdemir', 'role': 'CONTACT', 'email': 'cagriozdemir@gazi.edu.tr', 'phone': '+905544239196'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Çağrı Özdemir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'asst. prof.', 'investigatorFullName': 'Çağrı Özdemir', 'investigatorAffiliation': 'Gazi University'}}}}