Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-02-24 @ 5:07 AM
Study NCT ID:
NCT02169232
Status:
UNKNOWN
Last Update Posted:
2014-06-23
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055100', 'term': 'Optical Fibers'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-06-20', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-20', 'lastUpdatePostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The ease of intubation using a 10 cm visual analogue scale, completed both by the person performing the intubation, and an independent observer.', 'timeFrame': 'one hour'}, {'measure': "Post-operatively the patient's satisfaction", 'timeFrame': '24 hours', 'description': "Post-operatively the patient's satisfaction with the procedure using a 10 cm visual analogue scale, a discomfort scale using a 10 cm visual analogue scale, whether they would recommend this procedure to a future patient, and the severity of sore throat using a 10 cm visual analogue scale."}], 'primaryOutcomes': [{'measure': 'The time required for successful intubation', 'timeFrame': '10 minutes', 'description': 'The time required for successful intubation, which will be measured as the time from which the bronchoscope or videolaryngoscope is initially introduced into the oropharynx, until the time that CO2 is registered on the capnogram.'}], 'secondaryOutcomes': [{'measure': 'Number of intubation attempts, defined as a complete withdrawal and re-insertion of the airway instrument.', 'timeFrame': '10 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Awake intubation', 'Videolaryngoscope', 'Fiberoptic'], 'conditions': ['Need of Awake Intubation for Difficult Airways']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation of the morbidly obese is often performed awake. Fiberoptic bronchoscope assisted endotracheal intubation, a commonly utilized technique for securing an airway while a patient is awake, has many limitations. The video laryngoscope is a device that is similar to a conventional laryngoscope but uses a video system to visualize the larynx. Because of its low cost, ease of use, and usefulness in the presence of edema or bleeding that may obstruct the airway, video assisted laryngoscopy has been shown to be useful for awake endotracheal intubations. However, a direct comparison of the fiberoptic bronchoscope with video assisted laryngoscopy has not been performed for awake endotracheal intubations in of obese patients. Patients undergoing laparoscopic gastric bypas andrecquiring awake intubations will be randomized for either fiberoptic bronchoscope or video assisted laryngoscopy. The investigators primary outcome will be the time required for successful intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbidly obese patient presenting for bariatric surgery at the Royal Victoria Hospital\n\nExclusion Criteria:\n\n* moderate to severe systemic illness, i.e. American Society of Anesthesiologists (ASA) score of 4 or higher\n* inability to communicate in English or French\n* contraindications to the drugs used in the study'}, 'identificationModule': {'nctId': 'NCT02169232', 'briefTitle': 'Videolaryngoscope Versus Fiberoptic Bronchoscope for the Awake Intubation', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'orgStudyIdInfo': {'id': '13-443-SDR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Videolaryngoscope', 'description': 'Intubation by videolaryngoscope', 'interventionNames': ['Device: Videolaryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fiberoptic', 'description': 'Intubation by fibroscope', 'interventionNames': ['Device: Fiberoptic']}], 'interventions': [{'name': 'Videolaryngoscope', 'type': 'DEVICE', 'otherNames': ['Intubation by Glidoscope'], 'armGroupLabels': ['Videolaryngoscope']}, {'name': 'Fiberoptic', 'type': 'DEVICE', 'armGroupLabels': ['Fiberoptic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Albert Moore, MD', 'role': 'CONTACT', 'email': 'moore_albert@hotmail.com'}], 'facility': 'Royal Victoria Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Albert Moore, MD', 'role': 'CONTACT', 'email': 'moore_albert@hotmail.com'}, {'name': 'Aly Elbahrawy, MD', 'role': 'CONTACT', 'email': 'abahrawy@yahoo.com'}], 'overallOfficials': [{'name': 'Albert Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Albert Moore', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}