Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-01-02 @ 2:32 AM
Study NCT ID:
NCT03195504
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2017-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High-flow Nasal Oxygenation in Obese Patients During Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Consented patients will be randomly assigned either to the interventional group (High Flow Nasal Cannula- HFNC) or to the control group (CON). The Group HFNC will be preoxygenated using HFNC and the Group CON will receive standard preoxygenation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2017-06-05', 'studyFirstSubmitQcDate': '2017-06-19', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of safe apnea time', 'timeFrame': 'Maximum up to 6 minutes', 'description': 'Safe apnea time, defined by time to desaturation (SpO2 \\> 95%) or apnea maximum up to 6 minutes'}], 'secondaryOutcomes': [{'measure': 'Highest EtCO2', 'timeFrame': 'Every minute up to 5 minutes on commencing ventilation', 'description': 'Highest EtCO2 on commencing ventilation'}, {'measure': 'Lowest SpO2', 'timeFrame': 'Every minute up to 5 minutes after intubation', 'description': 'Lowest SpO2 during intubation procedure'}, {'measure': 'Time to regain baseline SpO2', 'timeFrame': 'Up to 5 minutes after intubation', 'description': 'Time to regain baseline SpO2 after intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apneic Oxygenation', 'High-flow Nasal Cannulae', 'Bariatric Surgery', 'Anesthesia Induction']}, 'referencesModule': {'references': [{'pmid': '31584919', 'type': 'DERIVED', 'citation': 'Wong DT, Dallaire A, Singh KP, Madhusudan P, Jackson T, Singh M, Wong J, Chung F. High-Flow Nasal Oxygen Improves Safe Apnea Time in Morbidly Obese Patients Undergoing General Anesthesia: A Randomized Controlled Trial. Anesth Analg. 2019 Oct;129(4):1130-1136. doi: 10.1213/ANE.0000000000003966.'}]}, 'descriptionModule': {'briefSummary': 'Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than18 years old\n* ASA status I-III\n* Elective surgery performed under general anesthesia requiring endotracheal intubation\n* BMI more than 40 kg/m2\n\nExclusion Criteria:\n\n* Chronic respiratory disease\n* SpO2 \\<98% after supplementing oxygen\n* Previous or anticipated difficult intubation\n* Uncontrolled hypertension\n* Ischemic heart disease\n* Congestive heart failure\n* Increased intracranial pressure\n* Uncontrolled GERD\n* Known allergy or contraindication to anesthesia drugs\n* Nasal blockade contraindicating the use of HFNC'}, 'identificationModule': {'nctId': 'NCT03195504', 'briefTitle': 'High-flow Nasal Oxygenation in Obese Patients During Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Effectiveness of Apneic Oxygenation Using High-flow Nasal Cannula in Morbidly Obese Patients Undergoing General Anesthesia', 'orgStudyIdInfo': {'id': '16-6264.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HFNC (High Flow Nasal Cannulae)', 'description': 'High Flow Nasal Cannulae providing humidified, high-flow oxygen during induction of anesthesia', 'interventionNames': ['Device: HFNC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CON (control)', 'description': 'Standard flow oxygen during induction of anesthesia', 'interventionNames': ['Device: CON (control)']}], 'interventions': [{'name': 'HFNC', 'type': 'DEVICE', 'description': 'High flow nasal oxygen (60 l) under GA', 'armGroupLabels': ['HFNC (High Flow Nasal Cannulae)']}, {'name': 'CON (control)', 'type': 'DEVICE', 'description': 'Standard oxygen (10-15 l) under GA', 'armGroupLabels': ['CON (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Anesthesia (MD)', 'investigatorFullName': 'David Wong', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}