Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-01-25 @ 5:54 AM
Study NCT ID:
NCT04087135
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2019-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006469', 'term': 'Hemoptysis'}, {'id': 'D002102', 'term': 'Cadaver'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003643', 'term': 'Death'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013396', 'term': 'Suction'}], 'ancestors': [{'id': 'D004322', 'term': 'Drainage'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant will performe the intubation three time using the tools provided, for the same simulation situation: (a) direct laryngoscopy, (b) videolaryngoscopy McGrath and (c) videolaryngoscopy McGrath with suction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2019-09-09', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'failure of intubation on first try', 'timeFrame': 'the duration of the simulation', 'description': 'defined as the withdrawal of the laryngoscope from the mouth'}], 'secondaryOutcomes': [{'measure': 'time to intubation', 'timeFrame': 'the duration of the simulation', 'description': 'from the insertion of the laryngoscope in the mouth to the inflation of the endotracheal cuff'}, {'measure': 'failure in intubation', 'timeFrame': 'the duration of the simulation', 'description': 'failure to intubate after three try'}, {'measure': 'use of suction', 'timeFrame': 'the duration of the simulation', 'description': 'document the use of suction'}, {'measure': 'difficulty of intubation', 'timeFrame': 'the duration of the simulation', 'description': 'as describe by the participants on a Likert scale 1 to 5'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['videolaryngoscopy', "Thiel's embalmed cadaver"], 'conditions': ['Laryngoscope', 'Hemoptysis', 'Simulation', 'Cadaver', 'Intubation; Difficult or Failed']}, 'descriptionModule': {'briefSummary': "Our study first aims to develope a realistic cadaver model of hemoptysis based on Thiel's embalmed cadavers. Secondly, participants will intubate the hemoptysis cadaver model with (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade and a suction advance before the optic of the camera. We hypothesis that, in simulated hemoptysis on the Thiel's embalmed cadaver, the rate of failed intubation at first try will be different depending on the laryngoscope used.", 'detailedDescription': "For the simulation of hemoptysis, we will need to use the Thiel's embalmed cadaver, who's realism is established, create a synthetic form of blood resembling real blood by its viscosity and color for the simulation and elaborate the dynamic interface of the simulation of hemoptysis. The quantity and way of administration of the blood through the trachea will be tested to obtain a realistic hemoptysis as seen in supraglottic.\n\nFor the simulation, we will compare the efficiency of intubation, judged by the failure rate of intubation on first try, for (a) the direct laryngoscopy with MacIntosh blade, (b) the videolaryngoscopy with McGrath XBlade and (c) the videolaryngoscopy with McGrath XBlade with the suction advanced before the camera. We will also measure the time to intubation, the failure rate of intubation, the suction use and the difficulty of intubation as reported by the participants."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all wiling doctors and medical residents in the departments of anesthesiology, emergency medicine and intensive care\n* experience with the technique of intubation using videolaryngoscopy and direct laryngoscopy.\n\nExclusion Criteria:\n\n* refusal to participate'}, 'identificationModule': {'nctId': 'NCT04087135', 'briefTitle': "Comparison of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method", 'organization': {'class': 'OTHER', 'fullName': 'Université de Montréal'}, 'officialTitle': "Comparison of the Success Rate of Intubation With Direct Laryngoscopy or Videolaryngoscopy in an Hemoptysis Simulated Situation on Human Cadaver Embalmed With Thiel's Method", 'orgStudyIdInfo': {'id': 'HP2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'participant LD', 'interventionNames': ['Other: direct laryngoscopy']}, {'type': 'EXPERIMENTAL', 'label': 'participant VL', 'interventionNames': ['Other: videolaryngoscopy McGrath']}, {'type': 'EXPERIMENTAL', 'label': 'participant VLS', 'interventionNames': ['Other: videolaryngoscopy McGrath with suction']}], 'interventions': [{'name': 'direct laryngoscopy', 'type': 'OTHER', 'description': 'Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.', 'armGroupLabels': ['participant LD']}, {'name': 'videolaryngoscopy McGrath', 'type': 'OTHER', 'description': 'Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)', 'armGroupLabels': ['participant VL']}, {'name': 'videolaryngoscopy McGrath with suction', 'type': 'OTHER', 'description': 'Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) and a suction they will advanced directly before the optic of the camera.', 'armGroupLabels': ['participant VLS']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2J3T5', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Trois-Rivières', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Montréal', 'class': 'OTHER'}, 'collaborators': [{'name': "Centre d'Apprentissage des Habiletés Cliniques (CAAHC)", 'class': 'UNKNOWN'}, {'name': "Laboratoire d'anatomie de Trois-Rivières", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}