Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:36 AM
Study NCT ID:
NCT07422467
Status:
COMPLETED
Last Update Posted:
2026-02-20
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bougie Use for Improving First-Pass Success in Novice Intubators
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized cross-over manikin study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Firs pass success', 'timeFrame': 'During procedure', 'description': 'The primary outcome of the study was first-pass success for each intubation technique. First-pass success was defined as successful placement of the endotracheal tube into the trachea on the first attempt.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway management', 'Bougie', 'Stylet', 'novice intubator', 'Video laryngoscope'], 'conditions': ['Endotracheal Intubation', 'Novice Doctor']}, 'descriptionModule': {'briefSummary': 'This was a prospective, randomized cross-over manikin study in which participants first completed a standardized two-hour theoretical and hands-on training session on airway anatomy, laryngoscopy techniques, and the use of stylet and bougie. Each participant subsequently performed four intubation techniques -direct and video laryngoscopy, each combined with either a stylet or a bougie- according to a randomized sequence on the same airway manikin using a 7.5-mm endotracheal tube. The primary outcome was first-pass success, defined as successful tracheal tube placement on the first attempt. The secondary outcome was intubation time, measured from initial contact of the laryngoscope blade with the manikin to successful advancement and release of the tube; attempts exceeding five minutes were classified as failed first-pass attempts.', 'detailedDescription': 'Airway management is a fundamental emergency medicine skill, and first-pass success in endotracheal intubation (ETI) is strongly operator-dependent. Novice intubators have lower success rates and a higher risk of complications, making the identification of simple and effective adjuncts essential in training environments. Although devices such as the bougie, stylet, and video laryngoscope are widely used, the most suitable combination for beginners remains uncertain. To address this, a controlled simulation study was conducted under standardized conditions.\n\nThis was a single-center, prospective, randomized cross-over manikin study conducted between April and July 2025 following ethics approval and written informed consent. Sixth-year medical students without prior real-world intubation experience were enrolled. Before the study procedures, all participants completed a standardized two-hour training session consisting of theoretical instruction and hands-on practice delivered in small groups by an emergency medicine specialist. Training focused on airway anatomy, laryngoscopy technique, and the correct use of both stylet and bougie, using the same airway manikin model employed in the study.\n\nParticipants were randomly assigned in a 1:1:1:1 ratio to one of four sequence groups using a computer-based online randomization tool. Each group followed a predefined order of four techniques-direct laryngoscopy with bougie (DL+B), direct laryngoscopy with stylet (DL+S), video laryngoscopy with bougie (VL+B), and video laryngoscopy with stylet (VL+S)-so that every participant performed all techniques once while minimizing order and learning effects associated with repeated attempts. Group allocation was determined before the session, and all intubations were performed according to the assigned sequence.\n\nIntubation attempts were performed on a human airway manikin using a Macintosh size 3 blade for direct laryngoscopy and an i-view disposable video laryngoscope for video laryngoscopy. A 7.5-mm endotracheal tube was used in all attempts, and either a stylet or a bougie was applied according to the allocated technique. A 10-minute rest period was provided between attempts to reduce fatigue-related bias.\n\nThe primary outcome was first-pass success, defined as successful placement of the endotracheal tube into the trachea on the first attempt. The secondary outcome was intubation time, measured from the moment the laryngoscope blade first contacted the manikin to the moment the endotracheal tube was successfully advanced into the trachea and released, as confirmed by study observers. Attempts lasting longer than five minutes were classified as failed first-pass attempts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixth-year medical students\n* Not on clinical duty at the time of participation\n* No scheduled clinical duty on the following day\n* Free of any acute illness at the time of the study\n* Exclusion Criteria:\n* Any prior real-world experience in endotracheal intubation'}, 'identificationModule': {'nctId': 'NCT07422467', 'briefTitle': 'Bougie Use for Improving First-Pass Success in Novice Intubators', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University Pendik Training and Research Hospital'}, 'officialTitle': 'Should the Bougie be Standard Practice for Novice Intubators? A Randomized Cross-Over Study', 'orgStudyIdInfo': {'id': '09.2025.25-0234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.', 'interventionNames': ['Other: video laryngoscope+ bougie,', 'Other: direct laryngoscope+ bougie', 'Other: video laryngoscope+stylet', 'Other: direct laryngoscope+stylet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'All novice intubators in Group B performed, in sequence, direct laryngoscope with bougie, video laryngoscope with bougie, direct laryngoscope with stylet, and video laryngoscope with stylet.', 'interventionNames': ['Other: video laryngoscope+ bougie,', 'Other: direct laryngoscope+ bougie', 'Other: video laryngoscope+stylet', 'Other: direct laryngoscope+stylet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'All novice intubators in Group C performed, in sequence, video laryngoscope with stylet, direct laryngoscope with stylet, video laryngoscope with bougie, and direct laryngoscope with bougie.', 'interventionNames': ['Other: video laryngoscope+ bougie,', 'Other: direct laryngoscope+ bougie', 'Other: video laryngoscope+stylet', 'Other: direct laryngoscope+stylet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'All novice intubators in Group D performed, in sequence, direct laryngoscope with stylet, video laryngoscope with stylet, direct laryngoscope with bougie, and video laryngoscope with bougie.', 'interventionNames': ['Other: video laryngoscope+ bougie,', 'Other: direct laryngoscope+ bougie', 'Other: video laryngoscope+stylet', 'Other: direct laryngoscope+stylet']}], 'interventions': [{'name': 'video laryngoscope+ bougie,', 'type': 'OTHER', 'description': 'All novice intubators performed these four intubation techniques in different sequences depending on the group allocation.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'direct laryngoscope+ bougie', 'type': 'OTHER', 'description': 'All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'video laryngoscope+stylet', 'type': 'OTHER', 'description': 'All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'direct laryngoscope+stylet', 'type': 'OTHER', 'description': 'All novice intubators in Group A performed, in sequence, video laryngoscope with bougie, direct laryngoscope with bougie, video laryngoscope with stylet, and direct laryngoscope with stylet.', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University Pendik Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Emre Kudu, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Marmara University Pendik Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University Pendik Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emre Kudu', 'investigatorAffiliation': 'Marmara University Pendik Training and Research Hospital'}}}}