Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-01 @ 10:37 PM
Study NCT ID:
NCT05239195
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
DirEct Versus VIdeo LaryngosCopE Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Jonathan.d.Casey@vumc.org', 'phone': '615-875-4681', 'title': 'Jonathan D Casey, MD, MSc', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen', 'otherNumAtRisk': 705, 'deathsNumAtRisk': 705, 'otherNumAffected': 0, 'seriousNumAtRisk': 705, 'deathsNumAffected': 184, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen', 'otherNumAtRisk': 712, 'deathsNumAtRisk': 712, 'otherNumAffected': 0, 'seriousNumAtRisk': 712, 'deathsNumAffected': 191, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Intubations With Successful Intubation on the First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '600', 'groupId': 'OG000'}, {'value': '504', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Severe Complications of Tracheal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'description': 'The secondary outcome is defined as the number of patients who experienced one or more of the following occurring between induction and 2 minutes after successful intubation:\n\n* Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry \\< 80%);\n* Severe hypotension (systolic blood pressure \\< 65 mm Hg or new or increased vasopressor administration);\n* Cardiac arrest not resulting in death within 1 hour of intubation; or\n* Cardiac arrest resulting in death within 1 hour of induction', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Duration of Laryngoscopy and Tracheal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '60'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '83'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube or tracheostomy tube in the trachea.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Laryngoscopy Attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '706', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'title': "Number of times a laryngoscope entered the patient's mouth (reported by observer) - 1", 'measurements': [{'value': '636', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}]}, {'title': "Number of times a laryngoscope entered the patient's mouth (reported by observer) - 2", 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}, {'title': "Number of times a laryngoscope entered the patient's mouth (reported by observer) - 3+", 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of procedure (minutes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of patients were missing this data variable.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'title': 'Endotracheal Tube - 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '646', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}]}, {'title': 'Endotracheal Tube - 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Endotracheal Tube - 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '705', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Bougie - 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '364', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}]}]}, {'title': 'Bougie - 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '316', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}]}, {'title': 'Bougie - 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Bougie - 3+', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Duration of procedure (minutes)', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not available for entire patient population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Successful Intubation on the First Attempt Without a Severe Complication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '484', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'description': 'This outcome reports the number of participants that experienced successful intubation on the first attempt without experiencing complications, a composite of two independent outcomes: successful intubation on the first attempt (the primary outcome of the trial) and severe complication (the secondary outcome of the trial).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Reason for Failure to Intubate on the First Attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'title': 'Inadequate view of the larynx', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}, {'title': 'Inability to intubate the trachea with an endotracheal tube', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Inability to cannulate the trachea with a bougie', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Attempt aborted due to change in patient condition', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'Providers could give more than one reason for failure to intubate on the first attempt for each intubation (not mutually exclusive). In addition, data on the reason for failure to intubate on the first attempt was missing for 23 patients in the video laryngoscope group and 40 patients in the direct laryngoscope group.\n\nReason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):\n\n* Inadequate view of the larynx\n* Inability to intubate the trachea with an endotracheal tube\n* Inability to cannulate the trachea with a bougie\n* Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding)\n* Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)\n* Other\n* Not Reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Operator-reported Aspiration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Esophageal Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Injury to the Teeth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'ICU-free Days in the First 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '25'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '24'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ventilator Free Days in the First 28 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '26'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All-cause In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'OG000'}, {'value': '712', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'OG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'classes': [{'categories': [{'measurements': [{'value': '184', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'FG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '707'}, {'groupId': 'FG001', 'numSubjects': '713'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '705'}, {'groupId': 'FG001', 'numSubjects': '712'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'After enrollment, discovered to be a person experiencing incarceration.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '705', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '1417', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.\n\nVideo Laryngoscope: Laryngoscope with a camera and a video screen'}, {'id': 'BG001', 'title': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.\n\nDirect Laryngoscope: Laryngoscope without a camera or a video screen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '66'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '67'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '67'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '240', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '465', 'groupId': 'BG000'}, {'value': '454', 'groupId': 'BG001'}, {'value': '919', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race or ethnic group', 'categories': [{'title': 'Non-Hispanic White', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '706', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Not reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '705', 'groupId': 'BG000'}, {'value': '712', 'groupId': 'BG001'}, {'value': '1417', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-30', 'size': 482407, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-03-21T16:58', 'hasProtocol': True}, {'date': '2022-11-08', 'size': 313781, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-21T16:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2022-02-03', 'resultsFirstSubmitDate': '2023-08-25', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-21', 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Duration of Laryngoscopy and Tracheal Intubation', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of an endotracheal tube or tracheostomy tube in the trachea.'}, {'measure': 'Number of Laryngoscopy Attempts', 'timeFrame': 'Duration of procedure (minutes)'}, {'measure': 'Number of Attempts to Cannulate the Trachea With a Bougie or an Endotracheal Tube', 'timeFrame': 'Duration of procedure (minutes)'}, {'measure': 'Successful Intubation on the First Attempt Without a Severe Complication', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'description': 'This outcome reports the number of participants that experienced successful intubation on the first attempt without experiencing complications, a composite of two independent outcomes: successful intubation on the first attempt (the primary outcome of the trial) and severe complication (the secondary outcome of the trial).'}, {'measure': 'Reason for Failure to Intubate on the First Attempt', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'Providers could give more than one reason for failure to intubate on the first attempt for each intubation (not mutually exclusive). In addition, data on the reason for failure to intubate on the first attempt was missing for 23 patients in the video laryngoscope group and 40 patients in the direct laryngoscope group.\n\nReason for failure among those who did not meet the primary outcome (successful intubation on the first attempt):\n\n* Inadequate view of the larynx\n* Inability to intubate the trachea with an endotracheal tube\n* Inability to cannulate the trachea with a bougie\n* Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding)\n* Technical failure of the laryngoscope (e.g., battery, light source, camera, screen)\n* Other\n* Not Reported'}, {'measure': 'Operator-reported Aspiration', 'timeFrame': 'from induction to 2 minutes following tracheal intubation'}, {'measure': 'Esophageal Intubation', 'timeFrame': 'from induction to 2 minutes following tracheal intubation'}, {'measure': 'Injury to the Teeth', 'timeFrame': 'from induction to 2 minutes following tracheal intubation'}, {'measure': 'ICU-free Days in the First 28 Days', 'timeFrame': '28 days'}, {'measure': 'Ventilator Free Days in the First 28 Days', 'timeFrame': '28 days'}, {'measure': 'All-cause In-hospital Mortality', 'timeFrame': '28 days'}], 'primaryOutcomes': [{'measure': 'Number of Intubations With Successful Intubation on the First Attempt', 'timeFrame': 'Duration of procedure (minutes)', 'description': 'The primary outcome is defined as placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and EITHER a single insertion of an endotracheal tube into the mouth OR a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube over the bougie into the mouth.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Severe Complications of Tracheal Intubation', 'timeFrame': 'from induction to 2 minutes following tracheal intubation', 'description': 'The secondary outcome is defined as the number of patients who experienced one or more of the following occurring between induction and 2 minutes after successful intubation:\n\n* Severe hypoxemia (lowest oxygen saturation measured by pulse oximetry \\< 80%);\n* Severe hypotension (systolic blood pressure \\< 65 mm Hg or new or increased vasopressor administration);\n* Cardiac arrest not resulting in death within 1 hour of intubation; or\n* Cardiac arrest resulting in death within 1 hour of induction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Illness', 'Emergency Airway Management', 'Tracheal intubation', 'Video laryngoscope', 'Direct laryngoscope'], 'conditions': ['Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '37326325', 'type': 'DERIVED', 'citation': 'Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz KP, Russell DW, Gaillard JP, Latimer AJ, Ghamande SA, Gibbs KW, Vonderhaar DJ, Whitson MR, Barnes CR, Walco JP, Douglas IS, Krishnamoorthy V, Dagan A, Bastman JJ, Lloyd BD, Gandotra S, Goranson JK, Mitchell SH, White HD, Palakshappa JA, Espinera A, Page DB, Joffe A, Hansen SJ, Hughes CG, George T, Herbert JT, Shapiro NI, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz DR, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE Investigators and the Pragmatic Critical Care Research Group. Video versus Direct Laryngoscopy for Tracheal Intubation of Critically Ill Adults. N Engl J Med. 2023 Aug 3;389(5):418-429. doi: 10.1056/NEJMoa2301601. Epub 2023 Jun 16.'}, {'pmid': '36639210', 'type': 'DERIVED', 'citation': 'Prekker ME, Driver BE, Trent SA, Resnick-Ault D, Seitz K, Russell DW, Gandotra S, Gaillard JP, Gibbs KW, Latimer A, Whitson MR, Ghamande S, Vonderhaar DJ, Walco JP, Hansen SJ, Douglas IS, Barnes CR, Krishnamoorthy V, Bastman JJ, Lloyd BD, Robison SW, Palakshappa JA, Mitchell S, Page DB, White HD, Espinera A, Hughes C, Joffe AM, Herbert JT, Schauer SG, Long BJ, Imhoff B, Wang L, Rhoads JP, Womack KN, Janz D, Self WH, Rice TW, Ginde AA, Casey JD, Semler MW; DEVICE investigators and the Pragmatic Critical Care Research Group. DirEct versus VIdeo LaryngosCopE (DEVICE): protocol and statistical analysis plan for a randomised clinical trial in critically ill adults undergoing emergency tracheal intubation. BMJ Open. 2023 Jan 13;13(1):e068978. doi: 10.1136/bmjopen-2022-068978.'}]}, 'descriptionModule': {'briefSummary': "Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. Failure to intubate the trachea on the first attempt occurs in more than 10% of all tracheal intubation procedures performed in the emergency department (ED) and intensive care unit (ICU). Improving clinicians rate of intubation on the first attempt could reduce the risk of serious procedural complications.\n\nIn current clinical practice, two classes of laryngoscopes are commonly used to help clinicians view the larynx while intubating the trachea: a video laryngoscope (equipped with a camera and a video screen) and a direct laryngoscope (not equipped with a camera or video screen). For nearly all laryngoscopy and intubation procedures performed in current clinical practice, clinicians use either a video or a direct laryngoscope. Prior research has shown that use of a video laryngoscope improves the operator's view of the larynx compared to a direct laryngoscope. Whether use of a video laryngoscope increases the likelihood of successful intubation on the first attempt remains uncertain. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to laryngoscopy and intubation could improve the care clinicians deliver and patient outcomes.", 'detailedDescription': 'Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). In 10-20% of emergency tracheal intubations, clinicians are unable to intubate the trachea on the first attempt, which increases the risk of peri-intubation complications. Successful laryngoscopy and tracheal intubation requires using a laryngoscope to \\[1\\] visualize the larynx and vocal cords and \\[2\\] create a pathway through which an endotracheal tube can be advanced through the oropharynx and larynx and into the trachea.\n\nIn current clinical practice, two classes of laryngoscopes are commonly used by clinicians to view the larynx while intubating the trachea: a video laryngoscope (equipped with a camera and a video screen) and a direct laryngoscope (not equipped with a camera or video screen). Clinicians use either a video laryngoscope or a direct laryngoscope as standard of care for every laryngoscopy and intubation procedure performed in current clinical practice.\n\nDirect Laryngoscope: The Macintosh direct laryngoscope consists of a battery-containing handle and a blade with a light source. The operator achieves a direct line of sight -from the operator\'s eye through the mouth to the larynx and trachea - by using the laryngoscope blade to displace the tongue and elevate the epiglottis.\n\nVideo Laryngoscope: Video laryngoscopes consist of a fiberoptic camera and light source near the tip of the laryngoscope blade, which transmits images to a video screen. The position of the camera near the tip of the laryngoscope blade facilitates visualization of the larynx and trachea.\n\nUse of a video laryngoscope and use of a direct laryngoscope are both common, standard-of-care approaches the clinicians use to perform tracheal intubation in the ED and ICU in current clinical care.\n\nCurrently, it is unknown whether use of a video laryngoscope or use of a direct laryngoscope has any effect on successful intubation on the first attempt or any other outcome. Some prior research has raised the hypothesis that using a video laryngoscope would increase clinicians\' rate of successful intubation on the first attempt by facilitating the view of the larynx. Some prior research has raised the hypothesis that using a direct laryngoscope would increase clinicians\' rate of successful intubation on the first attempt by facilitating a clear pathway for placement of the tube through the mouth into the trachea.\n\nTo date, 8 small single-center randomized trials and one 371-patient multicenter randomized clinical trial have been conducted under waiver of or alteration of informed consent to compare use of a video vs a direct laryngoscope in the setting of emergency tracheal intubation in the ED or ICU. Two of these trials provide the most direct preliminary data for this proposal. The "Facilitating EndotracheaL intubation by Laryngoscopy technique and apneic Oxygenation Within the ICU (FELLOW)" randomized clinical trial, conducted under waiver of informed consent, compared these two standard-of-care approaches during 150 emergency tracheal intubations at Vanderbilt University Medical Center, finding no difference in the rate of successful intubation on the first attempt between use of a video and use of a direct laryngoscope. The "McGrath Mac Videolaryngoscope Versus Macintosh Laryngoscope for Orotracheal Intubation in the Critical Care Unit (MACMAN)" randomized clinical trial among 371 critically ill adults found no difference between use of a video vs direct laryngoscope in the rate of successful intubation on the first attempt. However, a hypothesis-forming post-hoc exploratory analysis of peri-intubation complications suggested that use of a video laryngoscope may be associated with a higher rate of complications than direct laryngoscope (9.5% vs 2.8%, respectively, p=0.01). These trials were underpowered to rule out small but clinically significant differences in first pass success, and were limited to intubations performed by inexperienced trainees in one practice setting (intensive care units), but they demonstrated hypothesis-generating findings requiring validation in larger trials that reflect the full spectrum of settings, operator specialties, and operator experience levels in which emergency tracheal intubation is routinely performed.\n\nBecause of the imperative to optimize emergency tracheal intubation in clinical care, the common use of both video and direct laryngoscopes in current clinical practice, and the lack of definitive data from randomized trials to definitively inform whether use of a video laryngoscope or a direct laryngoscope effects the rate of successful intubation on the first attempt, examining whether one approach increases the odds of successful intubation on the first attempt represents an urgent research priority. To address this knowledge gap, the investigators propose to conduct a large, multicenter, randomized clinical trial comparing use of a video laryngoscope versus use of a direct laryngoscope with regard to successful intubation on the first attempt among critically ill adults undergoing tracheal intubation in the ED or ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is located in a participating unit.\n* Planned procedure is orotracheal intubation using a laryngoscope.\n* Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.\n\nExclusion Criteria:\n\n* Patient is known to be less than 18 years old.\n* Patient is known to be pregnant.\n* Patient is known to be a prisoner.\n* Immediate need for tracheal intubation precludes safe performance of study procedures.\n* Operator has determined that use of a video laryngoscope or use of a direct laryngoscope is required or contraindicated for the optimal care of the patient.'}, 'identificationModule': {'nctId': 'NCT05239195', 'acronym': 'DEVICE', 'briefTitle': 'DirEct Versus VIdeo LaryngosCopE Trial', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'DirEct Versus VIdeo LaryngosCopE Trial', 'orgStudyIdInfo': {'id': '211272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Video Laryngoscope Group', 'description': 'For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope.', 'interventionNames': ['Other: Video Laryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Direct Laryngoscope Group', 'description': 'For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape.', 'interventionNames': ['Other: Direct Laryngoscope']}], 'interventions': [{'name': 'Video Laryngoscope', 'type': 'OTHER', 'description': 'Laryngoscope with a camera and a video screen', 'armGroupLabels': ['Video Laryngoscope Group']}, {'name': 'Direct Laryngoscope', 'type': 'OTHER', 'description': 'Laryngoscope without a camera or a video screen', 'armGroupLabels': ['Direct Laryngoscope Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center | Ochsner Health System', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Health', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Matthew W Semler, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}, {'name': 'Adit A Ginde, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}, {'name': 'Matthew E Prekker, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}, {'name': 'Stacy A Trent, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Denver Health Medical Center'}, {'name': 'Brian E Driver, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hennepin County Medical Center, Minneapolis'}, {'name': 'Jonathan D Casey, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Following publication. No end date', 'ipdSharing': 'YES', 'description': 'Following publication, individual patient data will be made available for sharing to researchers with 1) a signed data access agreement, 2) research testing a hypothesis, 3) a protocol that has been approved by an institutional review board, and 4) a proposal that has received approval from the principal investigator.', 'accessCriteria': '1. a signed data access agreement\n2. research testing a hypothesis\n3. a protocol that has been approved by an institutional review board\n4. a proposal that has received approval from the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Casey', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}