Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-01 @ 6:34 AM
Study NCT ID:
NCT07022028
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ventilator Weaning Practices in Patients Intubated for Guillain-Barré Syndrome or Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}, {'id': 'D020275', 'term': 'Guillain-Barre Syndrome'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011129', 'term': 'Polyradiculoneuropathy'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with prolonged weaning', 'timeFrame': '7 days after the initial separation attempt from the ventilator', 'description': 'Prolonged weaning defined as still being under mechanical ventilation at least 7 days after the initial separation attempt from the ventilator'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Guillain-Barre syndrome', 'Ventilator Weaning', 'Airway Extubation', 'Intensive Care Unit'], 'conditions': ['Myasthenia Gravis', 'Guillain-Barre Syndrome']}, 'descriptionModule': {'briefSummary': 'Guillain-Barré syndrome and myasthenia gravis are two neuromuscular diseases that are commonly managed in ICUs that may require different weaning protocols. To date, no study has compared weaning modalities from mechanical ventilation in patients with these two diseases. Our objective was to assess and compare for ventilator weaning modalities between patients mechanically ventilated for Guillain-Barré syndrome or for myasthenia gravis in a large-scale multicenter study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients intubated and mechanically ventilated in ICUs for Guillain-Barré syndrome or myasthenia gravis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All patients mechanically ventilated for at least 48 hours for Guillain-Barré syndrome or myasthenia gravis -\n\nExclusion Criteria: Patients mechanically ventilated less than 48h or intubated for another reason than the neuromuscular disease.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07022028', 'acronym': 'GUIMAUVE', 'briefTitle': 'Ventilator Weaning Practices in Patients Intubated for Guillain-Barré Syndrome or Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Ventilator Weaning Practices in Patients Intubated for Guillain-Barré Syndrome or Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'GUIMAUVE study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients mechanically ventilated for Guillain-Barré syndrome or for myasthenia gravis (two groups)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU de POITIERS', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Arnaud W THILLE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Poitiers'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}