Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT01489605
Status:
WITHDRAWN
Last Update Posted:
2019-02-28
First Post:
2011-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Device Withdrawn from market', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02',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': '2011-12-08', 'studyFirstSubmitQcDate': '2011-12-08', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of Intubation', 'timeFrame': 'Day 1', 'description': 'Duration of Intubation - Mask removal to ETCO2 confirmation'}], 'secondaryOutcomes': [{'measure': 'Ease of intubation', 'timeFrame': 'Day 1', 'description': 'Ease of intubation as noted by operator (measured on a 100 mm Visual Analogue Scale)'}, {'measure': 'Incidence of trauma', 'timeFrame': 'Day 1', 'description': 'Incidence of trauma'}, {'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': 'Use of external laryngeal pressure'}, {'measure': 'Laryngoscopic grade distribution', 'timeFrame': 'Day 1', 'description': 'Laryngoscopic grade distribution according to Cormack and Lehane classification'}, {'measure': 'Sore Throat', 'timeFrame': 'Day 3', 'description': 'Patients will be surveyed with respect to the incidence of post-operative sore throat.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orotracheal intubation, videolaryngoscopy'], 'conditions': ['Intubation, Orotracheal']}, 'descriptionModule': {'briefSummary': 'Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the GlideScope Groove video-laryngoscope or the standard GlideScope video-laryngoscope.', 'detailedDescription': 'See above. The primary outcome is time to intubation.'}, '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.\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': 'NCT01489605', 'briefTitle': 'GlideScope Groove vs. Standard GlideScope: A Non-inferiority Study', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Comparison of GlideScope Groove to Standard GlideScope for Orotracheal Intubation: A Non-inferiority Study', 'orgStudyIdInfo': {'id': '18477'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GlideScope Groove', 'description': 'Patients will be intubated using the GlideScope Groove device. (Verathon)', 'interventionNames': ['Device: GlideScope Groove']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control: Standard GlideScope', 'description': 'Control: Patients will be intubated using standard practice, a standard GlideScope (Verathon)', 'interventionNames': ['Device: Control: Standard GlideScope']}], 'interventions': [{'name': 'GlideScope Groove', 'type': 'DEVICE', 'otherNames': ['Verathon'], 'description': 'Patients will be intubated using the GlideScope Groove device. (Verathon)', 'armGroupLabels': ['GlideScope Groove']}, {'name': 'Control: Standard GlideScope', 'type': 'DEVICE', 'otherNames': ['Varathon'], 'description': 'Patients will be intubated using the standard GlideScope. (Verathon)', 'armGroupLabels': ['Control: Standard GlideScope']}]}, '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': 'London Health Sciences Centre Victoria Campus', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Timothy Turkstra, MD, M. Eng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UWO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Western Ontario, Canada', '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"}}}}