Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 7:37 PM
Study NCT ID:
NCT01924559
Status:
COMPLETED
Last Update Posted:
2017-05-09
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Airway Intubation Devices When Using a Biohazard Suit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Marna.Greenberg@lvh.com', 'phone': '484-884-7514', 'title': 'Marna Rayl Greenberg, DO, MPH', 'organization': 'Lehigh Valley Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Limitations described in associated reference'}}, 'adverseEventsModule': {'timeFrame': 'Minimal risk study, N/A.', 'description': 'Minimal risk study, N/A.', 'eventGroups': [{'id': 'EG000', 'title': 'DL & Standard Clothing', 'description': 'Residents will intubate manikin using DL while wearing standard clothing.\n\nstandard clothing\n\nDL', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DL & Biohazard Gear', 'description': 'Residents will intubate manikins using DL while in Biohazard gear.\n\nBiohazard gear\n\nDL', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Glidescope & Standard Clothing', 'description': 'Residents will intubate manikins using Glidescope while wearing standard clothing.\n\nstandard clothing\n\nGlideScope', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Glidescope & Biohazard Gear', 'description': 'Residents will intubate manikins using Glidescope while wearing Biohazard gear.\n\nBiohazard gear\n\nGlideScope', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'SALT & Standard Clothing', 'description': 'Residents will intubate manikins using SALT while wearing standard clothing.\n\nstandard clothing\n\nSALT', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'SALT and Biohazard Gear', 'description': 'Residents will intubate manikins using SALT while wearing biohazard gear.\n\nBiohazard gear\n\nSALT No adverse events', 'otherNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Successful Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'DL & Standard Clothing', 'description': 'Residents will intubate manikin using DL while wearing standard clothing.\n\nstandard clothing\n\nDL'}, {'id': 'OG001', 'title': 'DL & Biohazard Gear', 'description': 'Residents will intubate manikins using DL while in Biohazard gear.\n\nBiohazard gear\n\nDL'}, {'id': 'OG002', 'title': 'Glidescope & Standard Clothing', 'description': 'Residents will intubate manikins using Glidescope while wearing standard clothing.\n\nstandard clothing\n\nGlidescope'}, {'id': 'OG003', 'title': 'Glidescope & Biohazard Gear', 'description': 'Residents will intubate manikins using Glidescope while wearing Biohazard gear.\n\nBiohazard gear\n\nGlidescope'}, {'id': 'OG004', 'title': 'SALT & Standard Clothing', 'description': 'Residents will intubate manikins using SALT while wearing standard clothing.\n\nstandard clothing\n\nSALT'}, {'id': 'OG005', 'title': 'SALT and Biohazard Gear', 'description': 'Residents will intubate manikins using SALT while wearing biohazard gear.\n\nBiohazard gear\n\nSALT'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '189'}, {'value': '106.5', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '534'}, {'value': '66', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '298'}, {'value': '83.5', 'groupId': 'OG003', 'lowerLimit': '25', 'upperLimit': '375'}, {'value': '73.5', 'groupId': 'OG004', 'lowerLimit': '13', 'upperLimit': '328'}, {'value': '58.5', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '168'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'approximately one minute', 'description': 'Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'EM Residents who tested/participated in each of the six groups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All 37 participants were scored under the same six scenarios, resulting in 222 observations.', 'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'The order in which subjects started scenarios (in biohazard gear vs street clothing) was randomized', 'groupId': 'FG000', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SALT and Biohazard Gear', 'description': 'All participants were tested on three intubation devices in either standard clothing or biohazard gear.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Prospectively enrolled EM residents, including PGY 1s through 4s; each resident was observed performing all six arms of the study.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-31', 'studyFirstSubmitDate': '2013-08-06', 'resultsFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-03-22', 'studyFirstPostDateStruct': {'date': '2013-08-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Successful Intubation', 'timeFrame': 'approximately one minute', 'description': 'Time from initiation of intubation attempt to successful 2 breaths demonstrating lung expansion, estimated less than 1 minute'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Airway'], 'conditions': ['Intubation; Difficult']}, 'referencesModule': {'references': [{'pmid': '25817200', 'type': 'RESULT', 'citation': 'Weaver KR, Barr GC Jr, Long KR, Diaz L Jr, Ratner AS, Reboul JP, Sturm DA, Greenberg MR, Dusza SW, Glenn-Porter B, Kane BG. Comparison of airway intubation devices when using a biohazard suit: a feasibility study. Am J Emerg Med. 2015 Jun;33(6):810-4. doi: 10.1016/j.ajem.2015.02.051. Epub 2015 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'We will investigate the impact biohazard gear has on time to successful intubation and, in particular, determine how the Supraglottic Airway Laryngopharyngeal Tube (Ecolab, Columbus, Missouri) device compares to traditional direct laryngoscopy and fiber-optic (video) intubation techniques.', 'detailedDescription': "This study will take place in an academic/training facility at Lehigh Valley Health Network simulating intubation during a bio-terrorism attack. As a part of their usual (standard of care) residency education, the study volunteers will be participating in a day-long airway training course in the Fall of 2013 where each of the tested devices will be introduced and the residents will be able to practice using them on a variety of training mannequins.\n\nAs part of this training, the enrolled study subjects will be timed using each of three intubation devices, both with and without wearing biohazard protective gear, for a total of six measurements per resident. Residents will have been assigned chronological numbers as they arrived and signed in for the course. These numbers will be also used for study identification numbers. Subjects will be randomized by odd or even identification numbers as to whether they will make their initial attempt in street clothing or the biohazard suit. This will help control for individual subject's skill learning. The subject will then intubate the same mannequins using each of the tested devices.\n\nThe order of devices used will be the same as in actual clinical practice: 1) Direct Laryngoscopy (the classic standard of care), 2) the GlideScope or C-MAC video laryngoscope (fiber-optic technology, which has become increasingly popular among emergency physicians), and 3) the Supraglottic Airway Laryngopharyngeal Tube airway device (an inexpensive, convenient supraglottic device that allows for a blind intubation technique through the device).\n\nData will be collected, per device, on the time taken and tubes used for each attempt. Demographic information will also be collected from participants such as gender, resident year, prior intubation experience, prior exposure to each of the tested devices, and experience wearing a biohazard suit. Study participants' satisfaction with each of the devices will also be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '126 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Emergency Medicine residents who volunteer to participate and allow their data to be used for research purposes\n\nExclusion Criteria:\n\n* Not an Emergency resident who volunteers to participate and allow their data to be used for research purposes'}, 'identificationModule': {'nctId': 'NCT01924559', 'briefTitle': 'Comparison of Airway Intubation Devices When Using a Biohazard Suit', 'organization': {'class': 'OTHER', 'fullName': 'Lehigh Valley Hospital'}, 'officialTitle': 'Comparison of Airway Intubation Devices When Using a Biohazard Suit: A Feasibility Study', 'orgStudyIdInfo': {'id': 'PRO00000982'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Laryngoscopy & standard clothing', 'description': 'Residents will intubate manikin using DL while wearing standard clothing.', 'interventionNames': ['Other: standard clothing', 'Device: Direct Laryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Laryngoscopy & Biohazard Gear', 'description': 'Residents will intubate manikins using DL while in Biohazard gear.', 'interventionNames': ['Other: Biohazard gear', 'Device: Direct Laryngoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'Glidescope & standard clothing', 'description': 'Residents will intubate manikins using Glidescope while wearing standard clothing.', 'interventionNames': ['Other: standard clothing', 'Device: Glidescope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Glidescope & Biohazard Gear', 'description': 'Residents will intubate manikins using Glidescope while wearing Biohazard gear.', 'interventionNames': ['Other: Biohazard gear', 'Device: Glidescope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supraglottic Airway & standard clothing', 'description': 'Residents will intubate manikins using Supraglottic Airway while wearing standard clothing.', 'interventionNames': ['Other: standard clothing', 'Device: Supraglottic Airway']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supraglottic Airway and Biohazard gear', 'description': 'Residents will intubate manikins using Supraglottic airway while wearing biohazard gear.', 'interventionNames': ['Other: Biohazard gear', 'Device: Supraglottic Airway']}], 'interventions': [{'name': 'standard clothing', 'type': 'OTHER', 'armGroupLabels': ['Direct Laryngoscopy & standard clothing', 'Glidescope & standard clothing', 'Supraglottic Airway & standard clothing']}, {'name': 'Biohazard gear', 'type': 'OTHER', 'armGroupLabels': ['Direct Laryngoscopy & Biohazard Gear', 'Glidescope & Biohazard Gear', 'Supraglottic Airway and Biohazard gear']}, {'name': 'Direct Laryngoscopy', 'type': 'DEVICE', 'otherNames': ['(the classic standard of care)'], 'armGroupLabels': ['Direct Laryngoscopy & Biohazard Gear', 'Direct Laryngoscopy & standard clothing']}, {'name': 'Glidescope', 'type': 'DEVICE', 'armGroupLabels': ['Glidescope & Biohazard Gear', 'Glidescope & standard clothing']}, {'name': 'Supraglottic Airway', 'type': 'DEVICE', 'otherNames': ['Supraglottic Airway Laryngopharyngeal Tube'], 'armGroupLabels': ['Supraglottic Airway & standard clothing', 'Supraglottic Airway and Biohazard gear']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Valley Hospital', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Scott Lipkin, DPM, CIP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director, Research Participant Protection Office'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lehigh Valley Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Emergency Medicine Research', 'investigatorFullName': 'Marna Rayl Greenberg', 'investigatorAffiliation': 'Lehigh Valley Hospital'}}}}