Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT02961933
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First pass success without hypoxemia', 'timeFrame': '10 minutes'}], 'secondaryOutcomes': [{'measure': 'Change in peri-intubation saturation', 'timeFrame': '0, 30, 60 and 120 seconds'}, {'measure': 'Saturation at time of tube placement', 'timeFrame': '10 minutes'}, {'measure': 'Time to desaturation <93%', 'timeFrame': 'measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes'}, {'measure': 'Saturation at post intubation', 'timeFrame': '0, 30, 60, and 120 seconds'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypoxemia', 'intubation', 'apneic oxygenation'], 'conditions': ['Intubation']}, 'descriptionModule': {'briefSummary': 'This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)\n\nExclusion Criteria:\n\n* Known prisoners\n* Patients in cardiac arrest\n* Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).'}, 'identificationModule': {'nctId': 'NCT02961933', 'acronym': 'USE AP OX', 'briefTitle': 'Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation', 'orgStudyIdInfo': {'id': '1050200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apneic oxygenation', 'interventionNames': ['Other: Apneic oxygenation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-apneic oxygenation', 'interventionNames': ['Other: Pre-oxgenation with NRB, NIPPV, BVM']}], 'interventions': [{'name': 'Apneic oxygenation', 'type': 'OTHER', 'description': 'Nasal cannula apneic oxygenation', 'armGroupLabels': ['Apneic oxygenation']}, {'name': 'Pre-oxgenation with NRB, NIPPV, BVM', 'type': 'OTHER', 'description': 'Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask', 'armGroupLabels': ['non-apneic oxygenation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Valerie Aston, MBA, RT', 'role': 'CONTACT', 'email': 'Valerie.Aston@imail.org', 'phone': '801-507-4606'}, {'name': 'Rob Bryant, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joseph Bledsoe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hill Stoecklein, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Megan Fix, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amber Bledsoe, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'centralContacts': [{'name': 'Valerie Aston, MBA, RT', 'role': 'CONTACT', 'email': 'valerie.aston@imail.org', 'phone': '801-507-4606'}], 'overallOfficials': [{'name': 'Robert Bryant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}