Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-30 @ 8:18 PM
Study NCT ID:
NCT05006651
Status:
UNKNOWN
Last Update Posted:
2021-08-16
First Post:
2021-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 325}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-08', 'studyFirstSubmitDate': '2021-08-08', 'studyFirstSubmitQcDate': '2021-08-08', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Intubation', 'timeFrame': '10 minute', 'description': 'Total intubation duration'}, {'measure': 'Intubation difficulty', 'timeFrame': '10 minute', 'description': 'Including Intubation difficulty scale, inubation attempt times, number of operator'}], 'secondaryOutcomes': [{'measure': 'Any injury during intubation', 'timeFrame': '24 hours', 'description': 'Including sore throat, hoarseness, trauma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'Intubation'], 'conditions': ['Intubation; Difficult or Failed', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Elective surgery needs intubation\n* ASA I to III\n* BMI\\>30kg/m2\n\nExclusion Criteria:\n\n* Head and neck cancer\n* Skull, neck fracture\n* Tracheal trauma\n* NPO\\< 8hr\n* Lung disease with hypoxemia\n* Mental Disorders\n* Patient wouldn't be extubated after operation immediately\n* Contraindicated to muscle relaxant"}, 'identificationModule': {'nctId': 'NCT05006651', 'briefTitle': 'Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient', 'organization': {'class': 'OTHER', 'fullName': 'Buddhist Tzu Chi General Hospital'}, 'officialTitle': 'Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient', 'orgStudyIdInfo': {'id': 'IRB109-265-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Laryngoscope', 'description': 'Intubation with traditional laryngoscope'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'McGrath MAC', 'description': 'Intubation with video laryngoscope', 'interventionNames': ['Device: McGrath MAC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trachway', 'description': 'Intubation with video stylet', 'interventionNames': ['Device: Trachway']}], 'interventions': [{'name': 'McGrath MAC', 'type': 'DEVICE', 'description': 'Intubaion with McGrath MAC', 'armGroupLabels': ['McGrath MAC']}, {'name': 'Trachway', 'type': 'DEVICE', 'description': 'Intubaion with Trachway', 'armGroupLabels': ['Trachway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'state': 'Hualien', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Hualien Tzu Chi Hospital', 'role': 'CONTACT', 'phone': '+8863-8561825'}], 'facility': 'Hualien Tzu Chi Hospital', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'centralContacts': [{'name': 'Ching-Hsuan Huang', 'role': 'CONTACT', 'email': 'velociraptor4226@gmail.com', 'phone': '+8863-8561825', 'phoneExt': '14360'}], 'overallOfficials': [{'name': 'Po-Kai Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Hualien Tzu Chi General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buddhist Tzu Chi General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}