Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-29 @ 11:30 AM
Study NCT ID:
NCT03295357
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2017-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-25', 'studyFirstSubmitDate': '2017-09-25', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of VAP (ventilator-associated pneumonia) during hospitalisation in the ICU', 'timeFrame': 'At baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extra-Corporeal Life Support']}, 'descriptionModule': {'briefSummary': 'There are no clear recommendations concerning the management of patients on ECLS (Extra-Corporeal Life Support). Many teams keep patients sedated until removal of the ECLS so as to avoid accidents, notably decannulation. Moreover, there are few publications on the subject, all the more so as the extubation of patients on ECLS (Extra-Corporeal Life Support) is a recent practice. Nonetheless, it is becoming more and more frequent in the cardiovascular ICU of Dijon University Hospital. We therefore wished to evaluate the benefits of this practice by comparing 2 populations: those with extubation while on ECLS (Extra-Corporeal Life Support) and those without.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients on ECLS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients over 18 years who were placed on ECLS between 1/01/14 and 31/12/15\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Patients on ECLS for a heart transplant\n* Patients who died within the first 48 hours following the initiation of ECLS'}, 'identificationModule': {'nctId': 'NCT03295357', 'acronym': 'EXTUB ECLS', 'briefTitle': 'Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Extubation of Patients on ECLS is Associated With a Reduction in Complications Related to Mechanical Ventilation: Retrospective Single-centre Study', 'orgStudyIdInfo': {'id': 'LAMIREL-GIRARD 2016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with extubation while on ECLS'}, {'label': 'Patients without extubation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}