Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-01-01 @ 1:35 PM
Study NCT ID:
NCT05050435
Status:
UNKNOWN
Last Update Posted:
2021-10-14
First Post:
2021-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Cardiac Extubation After Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-09-14', 'lastUpdatePostDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative complications', 'timeFrame': '30 days', 'description': 'Intensive care unit length of stay (days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-operative complications', 'on table extubation'], 'conditions': ['Post-operative Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The management of heart valve disease is constantly evolving over time. The minimally invasive approach (mini-thoracotomy and J-hemisternotomy) is one of the major surgical evolutions. It has many advantages including, among others, a reduction of postoperative pain and the preservation of sternal stability This evolution of the surgical technique towards a less invasive approach encouraged the investigators to adapt the anesthetic management accordingly. In particular, immediate postoperative extubation appeared feasible. The investigators would therefore like to test the hypothesis that immediate extuation is non-inferior to delayed extubation with regard to patient safety. The investigators also investigated whether immediate extubation could be beneficiel in terms of vasopressors requirement, risk of early postoperative complications, fluid balance and length of stay in the intesive care unit and in the hopsital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We included all the patients who have had minimally invasive valve replacement surgery in our service', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimally invasive valve replacement intervention (thoracotomy or J-hemisternotomy)\n\nExclusion Criteria:\n\n* Combined surgery'}, 'identificationModule': {'nctId': 'NCT05050435', 'briefTitle': 'Early Cardiac Extubation After Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Early Cardiac Extubation After Cardiac Surgery: a Retrospective Single-center Non-inferiority Trial', 'orgStudyIdInfo': {'id': 'Ulganescardio001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early extubated (in operating room) patients after valvular cardiac surgery', 'interventionNames': ['Procedure: Early extubation']}, {'label': 'Later extubated (in ICU) patients after valvular cardiac surgery'}], 'interventions': [{'name': 'Early extubation', 'type': 'PROCEDURE', 'description': 'Patients of the 2 groups are extubated at different moments: either immediately postoperatively, in the operating room, or after a few hours monitoring in ICU', 'armGroupLabels': ['Early extubated (in operating room) patients after valvular cardiac surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Océane Jaquet', 'role': 'CONTACT', 'email': 'jaquet.oceane@gmail.com', 'phone': '0032479760411'}], 'facility': 'ULiege - CHU', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Oceane Jaquet', 'role': 'CONTACT', 'email': 'jaquet.oceane@gmail.com', 'phone': '0032479760411'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}