Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT02841592
Status:
COMPLETED
Last Update Posted:
2018-01-30
First Post:
2016-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007316', 'term': 'Insemination, Artificial, Heterologous'}], 'ancestors': [{'id': 'D007315', 'term': 'Insemination, Artificial'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007314', 'term': 'Insemination'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-28', 'studyFirstSubmitDate': '2016-07-18', 'studyFirstSubmitQcDate': '2016-07-19', 'lastUpdatePostDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', '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': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '29089172', 'type': 'DERIVED', 'citation': 'Driver BE, Klein LR, Carlson K, Harrington J, Reardon RF, Prekker ME. Preoxygenation With Flush Rate Oxygen: Comparing the Nonrebreather Mask With the Bag-Valve Mask. Ann Emerg Med. 2018 Mar;71(3):381-386. doi: 10.1016/j.annemergmed.2017.09.017. Epub 2017 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'This crossover investigation enrolls healthy volunteers and compares the exhaled oxygen content (FeO2) between the non-rebreather mask at the flush rate and a bag-valve-mask device at the flush rate, used with active positive pressure assistance.'}, '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': 'NCT02841592', 'briefTitle': 'Non-rebreather at Flush Rate Compared to Bag Valve Mask With Assist', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'orgStudyIdInfo': {'id': '16-preox_3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-rebreather', 'description': 'This group will have a non-rebreather mask applied to the face and they will receive the flush rate oxygen intervention', 'interventionNames': ['Other: Flush rate oxygen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bag-valve-mask', 'description': 'With each inspiration from the subject, the ventilation bag will be gently squeezed to provide positive pressure and augment the amount of oxygen that is received by the subject for each breath. This group will receive the flush rate oxygen with assist intervention.', 'interventionNames': ['Other: Flush rate oxygen with assist']}], 'interventions': [{'name': 'Flush rate oxygen', 'type': 'OTHER', 'description': 'Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.', 'armGroupLabels': ['Non-rebreather']}, {'name': 'Flush rate oxygen with assist', 'type': 'OTHER', 'description': "Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.", 'armGroupLabels': ['Bag-valve-mask']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}]}, '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'}}}}