Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-28 @ 7:25 PM
Study NCT ID:
NCT05332860
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2022-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extubation Times in Postoperative Congenital Cardiovascular Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'extubation times', 'timeFrame': '10 days after surgery', 'description': 'postoperative mechanical ventilation times'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'on 10 days', 'description': 'mortality rates of groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital heart disease', 'perioperative management', 'pediatric cardiac surgery', 'extubation'], 'conditions': ['Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.\n\nMethods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.', 'detailedDescription': 'Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '72 patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective or emergency patients\n* aged 0-18 who are scheduled for congenital heart surgery\n\nExclusion Criteria:\n\n-in patients who died during the operation'}, 'identificationModule': {'nctId': 'NCT05332860', 'briefTitle': 'Extubation Times in Postoperative Congenital Cardiovascular Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, 'officialTitle': 'Evaluation of Factors Affecting Extubation Times in Postoperative Congenital Cardiovascular Surgeries: A Randomized Prospective Study', 'orgStudyIdInfo': {'id': 'Bursa Education Hospital'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Immediate Extubation or IE', 'description': 'patients were extubated in the operating room (OR) or in 6 hours after surgery', 'interventionNames': ['Procedure: Congenital Cardiovascular Surgery']}, {'label': 'Early Extubation or EE', 'description': 'patients were extubated within 6-48 hours of admission to the ICU', 'interventionNames': ['Procedure: Congenital Cardiovascular Surgery']}, {'label': 'Delayed Extubation or DE', 'description': 'patients were extubated sometime after 48 hours or not extubated', 'interventionNames': ['Procedure: Congenital Cardiovascular Surgery']}], 'interventions': [{'name': 'Congenital Cardiovascular Surgery', 'type': 'PROCEDURE', 'description': 'Relationship between perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in our hospital.', 'armGroupLabels': ['Delayed Extubation or DE', 'Early Extubation or EE', 'Immediate Extubation or IE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16600', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Tuğba T Onur, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Ümran Ü Karaca, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Anıl A Onur, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Mesut M Engin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Asiye A Demirel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Halil Erkan HE Sayan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Şeyda Efsun ŞE Özgünay, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Nermin N Kılıçarslan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Serkan S Seçici, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}, {'name': 'Selimcan S Yırtımcı, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa Yuksek Ihtisas Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Tugba Onur', 'investigatorAffiliation': 'Bursa Yuksek Ihtisas Training and Research Hospital'}}}}