Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT05145556
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2021-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Teach Intubation by Novices in Anaesthesiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Starting with 100 tracheal intubations with conventional tracheal intubation and videolaryngoscopy and after 100 intubations change the device for the next 100 intubations'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2021-11-25', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First pass success rate', 'timeFrame': 'at intubation in 60 seconds', 'description': 'successful tracheal intubation at the first attempt, compared to more than one attempt'}], 'secondaryOutcomes': [{'measure': 'Time to ventilation', 'timeFrame': 'at intubation in 120 seconds', 'description': 'From Insertion of the blase into the mouth until first ventilation'}, {'measure': 'Cormack and Lehane Classification', 'timeFrame': 'at intubation in 120 seconds', 'description': 'after insert the device the user describe the glottis visualisation'}, {'measure': 'Overall success rate', 'timeFrame': 'at intubation in 120 seconds', 'description': 'after two attempts using defined rescue techniques (e.g. rigid stylet, laryngeal mask)'}, {'measure': 'Subjective Training Process', 'timeFrame': 'at one month', 'description': 'after 25 intubation attempts'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tracheal Intubation, Learning Technique, Laryngoscope'], 'conditions': ['Learning Problem', 'Larynx']}, 'descriptionModule': {'briefSummary': 'Comparision of direct laryngoscopy and video laryngoscopy to learn successful tracheal intubation by novices in anaesthesiology', 'detailedDescription': 'Video laryngoscopy has been recommended as an alternative during difficult conventional direct laryngoscopy using the Macintosh blade. However, successful visualisation of the larynx and tracheal intubation using some of the indirect laryngoscopes or video laryngoscopy requires hand-eye coordination. To best of our knowledge in the current literature there are no data how is the best educative way to learn successful tracheal intubation by novices in anaesthesiology.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 Years\n* capacity to consent\n* Present written informed consent of the research participant\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Lack of consent\n* inability to consent'}, 'identificationModule': {'nctId': 'NCT05145556', 'acronym': 'TeachIntub', 'briefTitle': 'Teach Intubation by Novices in Anaesthesiology', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Comparision of Direct Laryngoscopy and Video Laryngoscopy to Learn Successful Tracheal Intubation by Novices in Anaesthesiology', 'orgStudyIdInfo': {'id': 'JohannesGUIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videolaryngoscopy (McGrath Macintosh)', 'description': 'First pass success rate using the videolaryngoscopy', 'interventionNames': ['Device: Videolarygoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'conventional direct laryngoscopy', 'description': 'First pass success rate using the conventional direct laryngoscopy', 'interventionNames': ['Device: conventional laryngoscopy']}], 'interventions': [{'name': 'Videolarygoscopy', 'type': 'DEVICE', 'description': 'In a randomised order we evaluate the first pass success rate of the tracheal tube into the trachea.', 'armGroupLabels': ['Videolaryngoscopy (McGrath Macintosh)']}, {'name': 'conventional laryngoscopy', 'type': 'DEVICE', 'description': 'In a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.', 'armGroupLabels': ['conventional direct laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marc Kriege, MD', 'role': 'CONTACT', 'phone': '00496131170'}], 'facility': 'Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'centralContacts': [{'name': 'Marc MK Kriege, PD Dr', 'role': 'CONTACT', 'email': 'MaKriege@uni-mainz.de', 'phone': '00496131170'}], 'overallOfficials': [{'name': 'Marc MK Kriege, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University JG, Mainz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Marc Kriege, MD', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}