Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT06400693
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2024-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}], 'ancestors': [{'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'single-center, randomized, controlled simulation study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-04-14', 'studyFirstSubmitQcDate': '2024-05-02', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation between both groups', 'timeFrame': 'Defined verbal sign of participant when given task is started and ended', 'description': 'Comparison of time (in seconds) until completion of preparation of necessary equipment for endotracheal intubation with and without template'}], 'secondaryOutcomes': [{'measure': 'Time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device between both groups', 'timeFrame': 'Defined verbal sign of participant when given task is started and ended', 'description': 'Comparison of time (in seconds) until completion of preparation of necessary equipment for supraglottic airway device with and without template'}, {'measure': 'Number of missing equipment for endotracheal intubation', 'timeFrame': 'immediately after completion of intervention', 'description': 'Comparison of number of missing equipment for endotracheal intubation with and without template'}, {'measure': 'Number of missing equipment for supraglottic airway between groups', 'timeFrame': 'immediately after completion of intervention', 'description': 'Comparison of missing equipment for supraglottic airway with and without template'}, {'measure': 'Number of wrong size/equipment between groups', 'timeFrame': 'immediately after completion of intervention', 'description': 'Comparison of number of wrong size/equipment with and without template'}, {'measure': 'Nasa Task Load Index', 'timeFrame': 'immediately after completion of all 3 assigned interventions on each study day', 'description': 'Comparison of work load using Nasa Task Load Index questionnaire with and without template'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Airway Management']}, 'descriptionModule': {'briefSummary': 'Comparison of preparation times (in seconds) for emergency airway management (equipment only) with and without a template.', 'detailedDescription': 'Comparison of time (in seconds) needed to prepare all necessary equipment for one form of emergency airway management with and without a template. Participants will be randomized to "preparation with template (A)" and "preparation without template (B)" and all participants will be measured twice for both arms A and B, however, evaluation will take place on two separate days. Methods of airway management evaluated will be endotracheal intubation, supraglottic airway device and oral fiberoptic intubation, with a total of three measurements per participant per study day and two study days per participant. Participants will be nurses in the intensive care unit and, as a control group, anesthesia nurses will also be evaluated in order to factor in the effects of experience. The study will take place in the usual work environment of participants and with the standard equipment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18 years and older\n* written informed consent\n* Qualification as a nurse (ICU or anesthesia)\n* employed with University Medical Centre of Johannes Gutenberg University (JGU) Mainz\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06400693', 'acronym': 'TemplateAirway', 'briefTitle': 'Templates as Cognitive Aids in Emergency Airway Equipment Preparation: the Template Airway Trial', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Evaluation and Comparison of Cognitive Aids in Emergency Airway Equipment Preparation: the Randomized, Controlled Template Airway Trial', 'orgStudyIdInfo': {'id': '2023-17375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Template', 'description': 'Template is provided to prepare necessary equipment for emergency airway management', 'interventionNames': ['Other: Endotracheal Intubation', 'Other: Supraglottic Airway']}, {'type': 'OTHER', 'label': 'No template', 'description': 'No template is provided to prepare necessary equipment for emergency airway management', 'interventionNames': ['Other: Endotracheal Intubation', 'Other: Supraglottic Airway']}], 'interventions': [{'name': 'Endotracheal Intubation', 'type': 'OTHER', 'description': 'Preparation of all necessary equipment for endotracheal intubation', 'armGroupLabels': ['No template', 'Template']}, {'name': 'Supraglottic Airway', 'type': 'OTHER', 'description': 'Preparation of all necessary equipment for laryngeal mask', 'armGroupLabels': ['No template', 'Template']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatine', 'country': 'Germany', 'facility': 'Department of Anaesthesiology, University Medical Centre of Johannes Gutenberg University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Katharina Epp, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Employee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Katharina Epp', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}