Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:36 PM
Study NCT ID:
NCT04948294
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2021-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients requiring tracheal intubation for general anesthesia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-26', 'studyFirstSubmitDate': '2021-06-26', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Immediately after tracheal intubation completed', 'description': 'the time for tracheal intubation'}], 'secondaryOutcomes': [{'measure': 'First-pass rate', 'timeFrame': 'Immediately after tracheal intubation completed', 'description': 'the success rate of tracheal intubation with one attempt'}, {'measure': 'Intubation-related complications', 'timeFrame': 'within 24 hours after surgery', 'description': 'the incidence of overall complications related with tracheal intubation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'descriptionModule': {'briefSummary': 'The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.', 'detailedDescription': 'In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade. In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving tracheal intubation for general anesthesia\n* Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.\n\nExclusion Criteria:\n\n* Body mass index \\<18.5 kg/m2 or \\>35 kg/m2\n* Patients with a history of airway surgery\n* Patients with increased risk of aspiration\n* Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx'}, 'identificationModule': {'nctId': 'NCT04948294', 'briefTitle': 'Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades', 'organization': {'class': 'OTHER', 'fullName': 'Kyung Hee University Hospital at Gangdong'}, 'officialTitle': 'Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade', 'orgStudyIdInfo': {'id': 'KHNMC 2019-07-020-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Channeled group', 'description': 'Group of patients using a channeled blade for videolaryngoscopy', 'interventionNames': ['Device: Channeled blade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-channeled group', 'description': 'Group of patients using a non-channeled blade (standard type) for videolaryngoscopy', 'interventionNames': ['Device: Non-channeled blade']}], 'interventions': [{'name': 'Channeled blade', 'type': 'DEVICE', 'description': 'In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation', 'armGroupLabels': ['Channeled group']}, {'name': 'Non-channeled blade', 'type': 'DEVICE', 'description': 'In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation', 'armGroupLabels': ['Non-channeled group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Gangdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyungseok Seo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyung Hee University Hospital at Gangdong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hyungseok Seo', 'investigatorAffiliation': 'Kyung Hee University Hospital at Gangdong'}}}}