Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-29 @ 3:11 AM
Study NCT ID:
NCT02798302
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2016-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bag Valve Mask vs Non-rebreather at Flush Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-28', 'studyFirstSubmitDate': '2016-06-06', 'studyFirstSubmitQcDate': '2016-06-08', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fraction of expired oxygen', 'timeFrame': '3 minutes', 'description': 'The fraction of expired oxygen will be measured after three minutes of preoxygenation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Respiratory Failure']}, 'descriptionModule': {'briefSummary': 'Healthy volunteers will participate in a crossover trial comparing preoxygenation with a non-rebreather mask to a bag-valve mask (with and without a simulated mask leak) at the flush rate of oxygen (fully opening standard oxygen flowmeter).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>17\n\nExclusion Criteria:\n\n* Pregnant\n* Any facial hair more than stubble that might impede a mask seal'}, 'identificationModule': {'nctId': 'NCT02798302', 'briefTitle': 'Bag Valve Mask vs Non-rebreather at Flush Rate', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Preoxygenation With a Bag Valve Mask vs Non-rebreather at Flush Rate', 'orgStudyIdInfo': {'id': 'Preox-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non rebreather', 'interventionNames': ['Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bag valve mask without leak', 'interventionNames': ['Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bag valve mask with simulated mask leak', 'interventionNames': ['Other: Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.']}], 'interventions': [{'name': 'Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.', 'type': 'OTHER', 'description': 'A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.', 'armGroupLabels': ['Bag valve mask with simulated mask leak', 'Bag valve mask without leak', 'Non rebreather']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Research Director', 'investigatorFullName': 'Brian Driver', 'investigatorAffiliation': 'Hennepin Healthcare Research Institute'}}}}