Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-01 @ 7:47 PM
Study NCT ID:
NCT01488695
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2011-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Device withdrawn from the market', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Intubation', 'timeFrame': 'Day 1', 'description': 'The intubation will be timed using a stopwatch.'}], 'secondaryOutcomes': [{'measure': 'Number of intubation attempts', 'timeFrame': 'Day 1', 'description': 'Number of intubation attempts'}, {'measure': 'Number of failures to intubate', 'timeFrame': 'Day 1', 'description': 'Number of failures to intubate'}, {'measure': 'Use of external laryngeal pressure', 'timeFrame': 'Day 1', 'description': 'Whether or not external laryngeal pressure was needed to facilitate tracheal intubation'}, {'measure': 'Laryngoscopic grade distribution', 'timeFrame': 'Day 1', 'description': 'Cormack and Lehane Grade observed during laryngoscopy'}, {'measure': 'Presence of Sore throat', 'timeFrame': 'Day 3', 'description': 'Sore throat will be graded on POD #2 as none, mild, moderate, or severe'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intubation', 'double lumen tube'], 'conditions': ['Intubation, Intratracheal']}, 'descriptionModule': {'briefSummary': 'A new GlideScope videolaryngoscope has been developed, which utilizes a track on the superior surface of the blade to guide the endotracheal tube, which is advanced in the track as opposed to "free-hand" along the inferior surface, where the camera is located. This new GlideScope can be used for double-lumen endotracheal tubes (DLT). The investigators hypothesize that this GlideScope will be easier to use than the Macintosh blade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any adult patient booked for elective surgery requiring orotracheal intubation with a double lumen endotracheal tube.\n\nExclusion Criteria:\n\n1. Any patient with cervical spine abnormalities.\n2. Any patients with known or probable difficult airways.\n3. Any patient requiring rapid sequence induction.'}, 'identificationModule': {'nctId': 'NCT01488695', 'briefTitle': 'GlideScope Groove Versus Macintosh Blade for Double-Lumen Endotracheal Tube Intubation', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Comparison of GlideScope Groove to Macintosh Blade for Orotracheal Intubation With Double-Lumen Endotracheal Tube: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '18478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GlideScope Groove', 'description': 'Patient will be intubated using the GlideScope Groove device.', 'interventionNames': ['Device: GlideScope Groove']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control Group: Macintosh Blade', 'interventionNames': ['Device: Control: Macintosh blade']}], 'interventions': [{'name': 'GlideScope Groove', 'type': 'DEVICE', 'otherNames': ['Verathon'], 'description': 'GlideScope Groove', 'armGroupLabels': ['GlideScope Groove']}, {'name': 'Control: Macintosh blade', 'type': 'DEVICE', 'otherNames': ['Mac 3, 4'], 'description': 'Control: Patients will be intubated using the Macintosh blade', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'N6A5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Victoria Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Timothy P Turkstra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Western Ontario, Canada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff anesthesiologist and Associate Professor', 'investigatorFullName': 'Timothy Turkstra', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}