Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT03447457
Status:
COMPLETED
Last Update Posted:
2018-02-27
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'FLORAL-ER is a before/after study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-02-26', 'lastUpdatePostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete regression of respiratory failure', 'timeFrame': 'one hour after initiation of oxygen strategies', 'description': 'respiratory rate less than 25 breaths per minute and regression of signs of increased work of breathing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the efficiency on respiratory failure regression of high-flow nasal oxygen therapy versus standard oxygen in patients admitted to the ED for de novo acute respiratory failure.', 'detailedDescription': 'Prospective observational before-after study at the ED in two French centers.\n\nSelection of patients with acute hypoxemic respiratory failure at the ED.\n\nApplication of oxygen strategy according to the period:\n\n* before period: standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir mask, with a flow rate adjusted to maintain a pulse oxymetry of at least 92%.\n* after period: high-flow oxygen therapy continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* de novo acute respiratory failure cowith the following criteria: a respiratory rate \\> 25 b/min, or signs of increased work of breathing.\n\nMain exclusion Criteria:\n\n* cardiogenic pulmonary edema,\n* acute exacerbation of chronic lung disease, respiratory acidosis (pH \\< 7.35 and PaCO2 \\> 50 mm Hg),\n* hemodynamic instability\n* Glasgow Coma Scale score of 12 points or less,\n* an urgent need for endotracheal intubation,'}, 'identificationModule': {'nctId': 'NCT03447457', 'briefTitle': 'Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Early Initiation of High-flow Nasal Cannula Oxygen Therapy in Patients With Acute Respiratory Failure in the Emergency Department: A Before-after Study', 'orgStudyIdInfo': {'id': 'FLORAL-ER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'standard oxygen group', 'description': 'Patients are treated with standard oxygen delivered through nasal cannula, face mask or non-rebreathing reservoir', 'interventionNames': ['Device: Standard oxygen']}, {'type': 'OTHER', 'label': 'High-flow oxygen group', 'description': 'Patients are treated with high-flow nasal cannula oxygen continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min', 'interventionNames': ['Device: High-flow oxygen']}], 'interventions': [{'name': 'High-flow oxygen', 'type': 'DEVICE', 'otherNames': ['High-flow nasal cannula oxygen therapy'], 'description': 'HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%', 'armGroupLabels': ['High-flow oxygen group']}, {'name': 'Standard oxygen', 'type': 'DEVICE', 'description': 'nasal cannula, face mask or non-rebreathing reservoir mask', 'armGroupLabels': ['standard oxygen group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79000', 'city': 'Niort', 'country': 'France', 'facility': 'CHG de Niort', 'geoPoint': {'lat': 46.32313, 'lon': -0.45877}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}], 'overallOfficials': [{'name': 'Jean MACE, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Hospitalier de Niort'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier de Niort', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}