Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-19 @ 9:29 AM
Study NCT ID:
NCT03399695
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2018-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-01-28', 'releaseDate': '2018-08-13'}, {'resetDate': '2019-07-10', 'releaseDate': '2019-04-19'}], 'estimatedResultsFirstSubmitDate': '2018-08-13'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FeO2 at 3 min', 'timeFrame': '3 minutes', 'description': 'end tidal oxygen fraction measured through a gas analyser'}], 'secondaryOutcomes': [{'measure': 'time to obtain an FeO2 at 90%', 'timeFrame': '6 minutes', 'description': 'time to obtain an end tidal oxygen fraction measured at 90% measured through a gas analyser'}, {'measure': 'proportion of adequate preoxygenation at 3 min', 'timeFrame': '6 minutes', 'description': 'proportion of adequate preoxygenation (FeO2=90%) at 3 min'}, {'measure': 'tolerance', 'timeFrame': '1 hour', 'description': 'self reported tolerance on a likert scale'}, {'measure': 'tolerance on VAS', 'timeFrame': '1 hour', 'description': 'self reported tolerance on a visual analogue scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoxygenation', 'high flow oxygen'], 'conditions': ['Anesthesia', 'Airway Morbidity', 'Safety Issues']}, 'referencesModule': {'references': [{'pmid': '30664524', 'type': 'DERIVED', 'citation': 'Hanouz JL, Lhermitte D, Gerard JL, Fischer MO. Comparison of pre-oxygenation using spontaneous breathing through face mask and high-flow nasal oxygen: A randomised controlled crossover study in healthy volunteers. Eur J Anaesthesiol. 2019 May;36(5):335-341. doi: 10.1097/EJA.0000000000000954.'}]}, 'descriptionModule': {'briefSummary': 'High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. However, its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement during preoxygenation before general anaesthesia.\n\nThe goal of the present study is to measure end tidal oxygen after 3 min of preoxygenation using the recommended method (spontaneous breathing of 100% inhaled oxygen through a face mask) and using high flow nasal canula oxygen, in healthy volunteers.', 'detailedDescription': 'High flow nasal cannula oxygen has been proposed to perform preoxygenation in patients with acute respiratory failure requiring orotracheal intubation in intensive care units. The results suggest that high flow oxygen could be superior to bag reservoir face mask in term of occurrence of severe hypoxemia during the intubation procedure.\n\nAt the present time its use for preoxygenation before the induction of general anaesthesia in operating room has never been evaluated in term of end tidal oxygen fraction which is the gold standard measurement ensuring that the functional residual capacity has been filled with oxygen.\n\nWe planned a randomised cross over study in healthy volunteers studying efficacy and tolerance of preoxygenation using spontaneous ventilation with 100% inhaled oxygen through a face mask connected to the anaesthesia machine and preoxygenation using high flow nasal cannula oxygen (60l/min).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers,\n* signed contentment\n\nExclusion Criteria:\n\n* any chronic or acute disease,\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT03399695', 'acronym': 'PreOx-OHD', 'briefTitle': 'Preoxygenation Using High Flow Oxygen : Efficacy and Tolerance in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Comparison of Efficacy and Tolerance of Preoxygenation Using High Flow Oxygen and Face Mask Breathing in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'ID RCB 2017-A02343-50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'spontaneous breathing through a face mask connected to the anaesthesia machine delivering 100% oxygen gas flow (15l/min)', 'interventionNames': ['Procedure: preoxygenation']}, {'type': 'EXPERIMENTAL', 'label': 'ohd', 'description': 'spontaneous breathing through a nasal cannula connected to an humidifier device delivering warm (37°C) high flow oxygen(60l/min)', 'interventionNames': ['Procedure: preoxygenation']}], 'interventions': [{'name': 'preoxygenation', 'type': 'PROCEDURE', 'description': 'spontaneous breathing', 'armGroupLabels': ['control', 'ohd']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'jean-luc Hanouz, md, phd', 'role': 'CONTACT', 'email': 'hanouz-jl@chu-caen.fr', 'phone': '02 31 06 47 36', 'phoneExt': '+33'}], 'facility': 'University Hospital of Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-08-13', 'type': 'RELEASE'}, {'date': '2019-01-28', 'type': 'RESET'}, {'date': '2019-04-19', 'type': 'RELEASE'}, {'date': '2019-07-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Hospital, Caen'}}}}