Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-27 @ 9:58 PM
Study NCT ID:
NCT01477450
Status:
COMPLETED
Last Update Posted:
2014-09-26
First Post:
2011-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bransord@uc.edu', 'title': 'Richard Branson', 'organization': 'University of Cincinnati'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1 L/Min ; 16 mL', 'description': 'Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2 L/Min ; 32 mL', 'description': 'Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3 L/Min ; 48 mL', 'description': 'Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Return of Oxygen Saturation to Baseline (Sea Level) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1 L/Min ; 16 mL', 'description': 'Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'OG001', 'title': '2 L/Min ; 32 mL', 'description': 'Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'OG002', 'title': '3 L/Min ; 48 mL', 'description': 'Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}], 'classes': [{'title': 'Reversal of hypoxemia after pulse-dose oxygen', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Non-reversal of hypoxemia after pulse-dose oxygen', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Reversal of hypoxemia after cylinder O2 delivery', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Non-reversal of hypoxemia after cylinder O2 delive', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3', 'groupIds': ['OG000'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.47', 'groupIds': ['OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '1.00', 'groupIds': ['OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '50 minutes', 'description': 'Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.', 'unitOfMeasure': 'participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 L/Min ; 16 mL', 'description': 'Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'FG001', 'title': '2 L/Min ; 32 mL', 'description': 'Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'FG002', 'title': '3 L/Min ; 48 mL', 'description': 'Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1 L/Min ; 16 mL', 'description': 'Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'BG001', 'title': '2 L/Min ; 32 mL', 'description': 'Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'BG002', 'title': '3 L/Min ; 48 mL', 'description': 'Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)\n\nPulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator\n\nCylinder oxygen delivery: Oxygen delivery from an oxygen cylinder'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-65 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-24', 'studyFirstSubmitDate': '2011-11-18', 'resultsFirstSubmitDate': '2014-01-01', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-24', 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return of Oxygen Saturation to Baseline (Sea Level) Values', 'timeFrame': '50 minutes', 'description': 'Oxygen will be titrated from either an oxygen concentrator or an oxygen cylinder in liters per minute until the oxygen saturation returns to the sea level value. The flow in liters per minute is the dependent variables. Each participant will experience induced hypoxemia followed by cylinder oxygen delivery; each will also experience induced hypoxemia followed by pulse-dose oxygen from a concentrator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypobaric hypoxemia', 'Altitude', 'Oxygen', 'oxygen concentrator'], 'conditions': ['Hypoxemia', 'Hypobaric Hypoxemia']}, 'descriptionModule': {'briefSummary': 'This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.', 'detailedDescription': 'Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.\n\nThe oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current altitude chamber certification\n* Age 18 years - 60 years\n\nExclusion Criteria:\n\n* Current upper respiratory infection\n* Current symptoms of lower respiratory infection -- productive cough'}, 'identificationModule': {'nctId': 'NCT01477450', 'briefTitle': 'Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects', 'orgStudyIdInfo': {'id': 'Branson-2010-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 L/min ; 16 mL', 'description': 'Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)', 'interventionNames': ['Device: Pulse-dose oxygen', 'Device: Cylinder oxygen delivery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 L/min ; 32 mL', 'description': 'Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)', 'interventionNames': ['Device: Pulse-dose oxygen', 'Device: Cylinder oxygen delivery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 L/min ; 48 mL', 'description': 'Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)', 'interventionNames': ['Device: Pulse-dose oxygen', 'Device: Cylinder oxygen delivery']}], 'interventions': [{'name': 'Pulse-dose oxygen', 'type': 'DEVICE', 'description': 'Pulsed-dose oxygen delivery from an oxygen concentrator', 'armGroupLabels': ['1 L/min ; 16 mL', '2 L/min ; 32 mL', '3 L/min ; 48 mL']}, {'name': 'Cylinder oxygen delivery', 'type': 'DEVICE', 'description': 'Oxygen delivery from an oxygen cylinder', 'armGroupLabels': ['1 L/min ; 16 mL', '2 L/min ; 32 mL', '3 L/min ; 48 mL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78235', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooks City Base', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Richard Branson, MSc RRT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Air Force', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Rich Branson, M.D.', 'investigatorAffiliation': 'University of Cincinnati'}}}}