Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05132751
Status:
UNKNOWN
Last Update Posted:
2021-11-24
First Post:
2021-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'ventilator decision system'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-12', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-11-12', 'lastUpdatePostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mechanical ventilation time', 'timeFrame': 'through study completion, an average of 5 days'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay time', 'timeFrame': 'through study completion, an average of 1 week'}, {'measure': 'Length of hospital stay', 'timeFrame': 'through study completion, an average of 2 weeks'}, {'measure': 'In-hospital mortality', 'timeFrame': 'through study completion, an average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation', 'Critically Ill Patients']}, 'descriptionModule': {'briefSummary': "Ventilator-induced lung injury is associated with increased morbidity and mortality. Despite intense efforts in basic and clinical research, an individualized ventilation strategy for critically ill patients remains a major challenge. However, an individualized mechanical ventilation approach remains a challenging task: A multitude of factors, e.g., lab values, vitals, comorbidities, disease progression, and other clinical data must be taken into consideration when choosing a patient's specific optimal ventilation regime. The aim of this work was to evaluate the machine learning ventilator decision system, which is able to suggest a dynamically optimized mechanical ventilation regime for critically-ill patients. Compare with standard controlled ventilation, to test whether the clinical application of the machine learning ventilator decision system reduces mechanical ventilation time and mortality."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. only the first ICU stay was eligible;\n2. adults ≥ 18 years of age on ICU admission;\n3. estimate mechanical ventilation time ≥24 hours;'}, 'identificationModule': {'nctId': 'NCT05132751', 'briefTitle': 'Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'The Second Clinical Medical College of Jinan University'}, 'officialTitle': 'Effect of a Machine Learning Ventilator Decision System Versus Standard Controlled Ventilation on in Critical Care: a Randomized Trial', 'orgStudyIdInfo': {'id': 'LL-KY-2021396'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Machine Learning Ventilator Decision System Ventilation', 'interventionNames': ['Device: Machine Learning Ventilator Decision System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Standard Controlled Ventilation', 'interventionNames': ['Device: Machine Learning Ventilator Decision System']}], 'interventions': [{'name': 'Machine Learning Ventilator Decision System', 'type': 'DEVICE', 'description': 'Artificial intelligence ventilator system for personalized mechanical ventilation', 'armGroupLabels': ['Group A', 'Group B']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hu Anmin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Second Clinical Medical College of Jinan University', 'investigatorFullName': 'Hu Anmin', 'investigatorAffiliation': 'The Second Clinical Medical College of Jinan University'}}}}