Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-03 @ 6:08 AM
Study NCT ID:
NCT03118804
Status:
COMPLETED
Last Update Posted:
2022-11-30
First Post:
2017-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-28', 'studyFirstSubmitDate': '2017-04-09', 'studyFirstSubmitQcDate': '2017-04-16', 'lastUpdatePostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning duration', 'timeFrame': '48 hours', 'description': 'Time of weaning duration from SBT to weaning from mechanical ventilation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weaning', 'Mechanical ventilation', 'Electrical impedance tomography', 'Tidal distribution'], 'conditions': ['Mechanical Ventilation']}, 'descriptionModule': {'briefSummary': 'To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation', 'detailedDescription': '53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with mechanical ventilation admitted to ICU of Zhongda hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Intubated patients age between 18 years old and 80 years old\n2. Duration of controlled mechanical ventilation≥ 24 h\n3. Patients ready to wean from mechanical ventilation\n4. Informed consent\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Patients with malignant tumor\n3. High paraplegia, neuromuscular lesions\n4. Thoracic deformity, diaphragmatic hernia\n5. Patients with ECMO\n6. Patient participated in another interventional trial before enrollment'}, 'identificationModule': {'nctId': 'NCT03118804', 'briefTitle': 'Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT', 'organization': {'class': 'OTHER', 'fullName': 'Southeast University, China'}, 'officialTitle': 'Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT', 'orgStudyIdInfo': {'id': '2016ZDSYLL064-Y01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Weaning Guide by EIT', 'description': 'Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT', 'interventionNames': ['Diagnostic Test: Assessment of Lung Tidal Distribution With EIT']}], 'interventions': [{'name': 'Assessment of Lung Tidal Distribution With EIT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure', 'armGroupLabels': ['Weaning Guide by EIT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Liu Songqiao, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeast University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southeast University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Songqiao Liu', 'investigatorAffiliation': 'Southeast University, China'}}}}