Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-28 @ 9:25 AM
Study NCT ID:
NCT02864459
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2016-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Muscular Ultrasound in Predicting Weaning Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2016-08-07', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Extubation success (no need for reintubation)', 'timeFrame': '48 hours after extubation'}], 'secondaryOutcomes': [{'measure': 'Weaning success (no need for applying the ventilator again)', 'timeFrame': '2 hours after spontaneous breathing trial'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasonography', 'Weaning'], 'conditions': ['Respiratory Insufficiency']}, 'descriptionModule': {'briefSummary': 'When attempting to wean a patient from the ventilator, even if he/she passes the spontaneous breathing test, 10-20% of the time extubation failure occurs and the patient is reintubated. When the patient is reintubated the mortality rate increases and the length of intensive care unit stay is also increased. It is vital to intensively assess the patient before extubation and correctly predict extubation success. Muscular ultrasound may be helpful in these situations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing weaning from mechanical ventilation\n* Patients who have been mechanically ventilated for more than 72 hrs\n\nExclusion Criteria:\n\n* Pregnant patients\n* Patients with previous neuromuscular diseases\n* Difficulties in muscular ultrasound (Dressing, operation, etc)'}, 'identificationModule': {'nctId': 'NCT02864459', 'briefTitle': 'The Role of Muscular Ultrasound in Predicting Weaning Success', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Role of Muscular Ultrasound in Predicting Weaning Success', 'orgStudyIdInfo': {'id': '690'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscular ultrasound', 'interventionNames': ['Other: Muscular ultrasound']}], 'interventions': [{'name': 'Muscular ultrasound', 'type': 'OTHER', 'description': 'Muscular ultrasound is done before extubation', 'armGroupLabels': ['Muscular ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jinwoo Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}