Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-31 @ 7:02 PM
Study NCT ID:
NCT00917033
Status:
COMPLETED
Last Update Posted:
2010-02-24
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-23', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2009-06-09', 'lastUpdatePostDateStruct': {'date': '2010-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to intubate', 'timeFrame': 'Measured during intubation (seconds)'}], 'secondaryOutcomes': [{'measure': 'Number of intubation attempts', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Lowest arterial oxygen saturation during intubation', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Subjective difficulty of intubation', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Cormack-Lehane Score', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Airway mucosal trauma', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Dental injury', 'timeFrame': 'Measured during intubation (seconds)'}, {'measure': 'Post-procedure sore throat', 'timeFrame': 'One hour post-operative'}, {'measure': 'Post-procedure hoarseness of voice', 'timeFrame': 'One hour post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intubation, Endotracheal', 'Anesthesia, General', 'Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether orotracheal intubation in morbidly obese patients is faster, gentler and safer using the GlideScope videolaryngoscope than with the Macintosh direct laryngoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Approved for elective bariatric surgery at Glostrup University Hospital, Copenhagen.\n* Body Mass Index at least 35 kg/m2\n* Written informed consent to participate\n\nExclusion Criteria:\n\n* Mental illness\n* Abuse of alcohol or other substances\n* Previous difficult tracheal intubation\n* Considered non-eligible for safety-reasons by the anesthetist in charge'}, 'identificationModule': {'nctId': 'NCT00917033', 'briefTitle': 'Tracheal Intubation of Morbidly Obese Patients. GlideScope Versus Direct Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Orotracheal Intubation of Morbidly Obese Patients. A Randomised Controlled Trial Comparing the GlideScope Videolaryngoscope to the Macintosh Direct Laryngoscope.', 'orgStudyIdInfo': {'id': 'LHA GS 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GlideScope', 'description': 'Orotracheal intubation using the GlideScope videolaryngoscope', 'interventionNames': ['Device: GlideScope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Macintosh', 'description': 'Orotracheal intubation using the Macintosh direct laryngoscope', 'interventionNames': ['Device: Macintosh direct laryngoscope']}], 'interventions': [{'name': 'GlideScope', 'type': 'DEVICE', 'description': 'Orotracheal intubation', 'armGroupLabels': ['GlideScope']}, {'name': 'Macintosh direct laryngoscope', 'type': 'DEVICE', 'description': 'Orotracheal intubation', 'armGroupLabels': ['Macintosh']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Copenhagen', 'state': 'Glostrup', 'country': 'Denmark', 'facility': 'Department of Anesthesia, Glostrup University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Lasse H Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glostrup University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mr. Lasse Hoegh Andersen, M.D.', 'oldOrganization': 'Department of Anaesthesia, Glostrup University Hospital, Denmark'}}}}