Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01243918
Status:
TERMINATED
Last Update Posted:
2013-10-07
First Post:
2010-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Difficulty of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-04', 'studyFirstSubmitDate': '2010-11-18', 'studyFirstSubmitQcDate': '2010-11-18', 'lastUpdatePostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcul of the ratio PaO2/FiO2', 'timeFrame': 'one hour after each system used', 'description': 'The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2'}], 'secondaryOutcomes': [{'measure': 'number of participants with adverse events', 'description': 'The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:\n\n* number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events\n* impact on work of breathing: measure of respiratory frequency and blood gas\n* measure of positive and expiratory pressure'}, {'measure': 'measure of respiratory frequency and blood gas', 'description': 'The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:\n\n* number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events\n* impact on work of breathing: measure of respiratory frequency and blood gas\n* measure of positive and expiratory pressure'}, {'measure': 'measure of positive and expiratory pressure', 'description': 'The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:\n\n* number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events\n* impact on work of breathing: measure of respiratory frequency and blood gas\n* measure of positive and expiratory pressure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute respiratory failure', 'Oxygen therapy delivery systems', 'Non invasive ventilation', 'High concentration mask', 'Hypoxemic pneumonia'], 'conditions': ['Acute Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized in the intensive care unit of Nantes University Hospital\n* Signed informed consent\n* Patient with not hypercapnic acute hypoxemic respiratory failure\n* Immunocompetent and immunodeficient patient\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnancy\n* Contra-indication to non invasive ventilation\n* Allergy to xylocaine\n* Coagulation troubles\n* Tracheotomized patient\n* Urgent indication to intubation\n* Hypercapnic acute respiratory failure\n* Acute pulmonary edema\n* Face or nose malformation'}, 'identificationModule': {'nctId': 'NCT01243918', 'acronym': 'OPTI O2', 'briefTitle': 'Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure', 'orgStudyIdInfo': {'id': '10/6-D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VNI/Optiflow, Immunodeficient patients', 'description': 'VNI = non invasive ventilation', 'interventionNames': ['Other: Oxygen therapy delivery systems']}, {'type': 'EXPERIMENTAL', 'label': 'Optiflow/VNI, Immunodeficient patients', 'description': 'VNI = non invasive ventilation', 'interventionNames': ['Other: Oxygen therapy delivery systems']}, {'type': 'EXPERIMENTAL', 'label': 'Ospal/Optiflow, Immunocompetent patients', 'interventionNames': ['Other: Oxygen therapy delivery systems']}, {'type': 'EXPERIMENTAL', 'label': 'Optiflow/Ospal, Immunocompetent patients', 'interventionNames': ['Other: Oxygen therapy delivery systems']}], 'interventions': [{'name': 'Oxygen therapy delivery systems', 'type': 'OTHER', 'description': 'T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2', 'armGroupLabels': ['Optiflow/Ospal, Immunocompetent patients', 'Optiflow/VNI, Immunodeficient patients', 'Ospal/Optiflow, Immunocompetent patients', 'VNI/Optiflow, Immunodeficient patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Noëlle BRULE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}