Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2026-02-25 @ 1:54 AM
Study NCT ID:
NCT06332768
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-20', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weaning failure', 'timeFrame': '48 hrs', 'description': 'Weaning failure and re-intubation or recanulation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Ventilation Complication', 'Weaning Failure', 'Acute Respiratory Distress Syndrome', 'High-flow Oxygenation']}, 'descriptionModule': {'briefSummary': 'The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.', 'detailedDescription': 'HFNO (high-flow nasal oxygenation and NIV (non invasive ventilation) are to be randomly compared in the ARDS postextubation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nARDS\n\nExclusion Criteria:\n\nSevere ICU-aquired weakness Severe COPD'}, 'identificationModule': {'nctId': 'NCT06332768', 'briefTitle': 'NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Northern State Medical University'}, 'officialTitle': 'Comparison of High Flow Oxygenation, Noninvasive Ventilation and Standard Oxygen Therapy in the Early Post-extubation Period in Patients With Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'WEAN_2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NIV', 'description': 'Non-invasive ventilation', 'interventionNames': ['Device: Respiratory support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HFO', 'description': 'High Flow Oxygenation', 'interventionNames': ['Device: Respiratory support']}], 'interventions': [{'name': 'Respiratory support', 'type': 'DEVICE', 'otherNames': ['Oxygenation'], 'description': 'High-flow nasal oxygenation', 'armGroupLabels': ['HFO', 'NIV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '163000', 'city': 'Arkhangelsk', 'state': 'Arkhangelskaya oblast', 'country': 'Russia', 'facility': 'City hospital # 1', 'geoPoint': {'lat': 64.5461, 'lon': 40.55183}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern State Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the anesthesiology and intensive care department', 'investigatorFullName': 'Mikhail Y. Kirov', 'investigatorAffiliation': 'Northern State Medical University'}}}}