Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 5:13 PM
Study NCT ID:
NCT05798234
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2023-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Associated With Failure of HFNO in COVID-19 ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-03', 'studyFirstSubmitDate': '2023-04-03', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High flow oxygen failure', 'timeFrame': 'icu stay duration', 'description': 'patients requiring initial high flow oxygen but finally intubated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COVID-19 Pneumonia']}, 'descriptionModule': {'briefSummary': 'To determine the factors associated with OHD failure in COVID-19 patients admitted to an Intensive Care Unit', 'detailedDescription': 'Patients admitted into 1 participating ICU for acute hypoxemic respiratory failure due to COVID-19 between 02/01/2020 and 06/01/2022 will be assessed for OHD failure'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted in ICU for COVID-19 pneumonia\n\nExclusion Criteria:\n\n* under immediate ECMO\n* secondary transferred from another ICU\n* readmission in the ICU\n* initial limitation of care'}, 'identificationModule': {'nctId': 'NCT05798234', 'acronym': 'CO-OHD', 'briefTitle': 'Factors Associated With Failure of HFNO in COVID-19 ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Factors Associated With Failure of HFNO in COVID-19 ICU Patients', 'orgStudyIdInfo': {'id': '2022PI120'}}, 'armsInterventionsModule': {'interventions': [{'name': 'high flow oxygen device', 'type': 'DEVICE', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nancy', 'country': 'France', 'facility': 'Service de Réanimation Médicale, Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}