Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 3:49 PM
Study NCT ID:
NCT06964295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 74}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-30', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-30', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First-attempt success rate of nasotracheal intubation', 'timeFrame': 'At the time of tracheal intubation', 'description': 'The proportion of patients in whom nasotracheal intubation is successfully completed on the first attempt, comparing the videolaryngoscope group with the flexible bronchoscope group.'}], 'secondaryOutcomes': [{'measure': 'Degree of subglottic injury', 'timeFrame': 'At the time of extubation', 'description': 'Graded from 0 to 3 using a flexible bronchoscope'}, {'measure': 'Postoperative sore throat severity', 'timeFrame': '1 hour and 24 hours postoperatively', 'description': 'Assessed using the Numeric Rating Scale (0-10) at 1 and 24 hours after surgery.'}, {'measure': 'Incidence of postoperative hoarseness', 'timeFrame': '1 hour and 24 hours postoperatively', 'description': 'Presence or absence of hoarseness evaluated at 1 hour and 24 hours postoperatively.'}, {'measure': 'Cormack-Lehane grade', 'timeFrame': 'At the time of tracheal intubation', 'description': 'Grading recorded during intubation to evaluate glottic exposure.'}, {'measure': 'Changes in blood pressure', 'timeFrame': 'Within 5 minutes before and after intubation', 'description': 'Changes in blood pressure recorded before and after tracheal intubation.'}, {'measure': 'POGO score', 'timeFrame': 'At the time of tracheal intubation', 'description': 'Visualization scores recorded during intubation to evaluate glottic exposure.'}, {'measure': 'Changes in heart rate', 'timeFrame': 'Within 5 minutes before and after intubation', 'description': 'Changes in heart rate recorded before and after tracheal intubation.'}, {'measure': 'Changes in saturation', 'timeFrame': 'Within 5 minutes before and after intubation', 'description': 'Changes in SpO₂ recorded before and after tracheal intubation.'}, {'measure': 'Changes in bispectral value', 'timeFrame': 'Within 5 minutes before and after intubation', 'description': 'Changes in BIS values recorded before and after tracheal intubation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intubation Complication']}, 'descriptionModule': {'briefSummary': 'Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* History of gastroesophageal reflux disease\n* History of surgery or radiation therapy involving the upper airway\n* Presence of severely loose teeth'}, 'identificationModule': {'nctId': 'NCT06964295', 'briefTitle': 'Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2503-041-1621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videolaryngoscope Group', 'interventionNames': ['Device: Macintosh videolaryngoscope']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flexible Bronchoscope Group', 'interventionNames': ['Device: Flexible bronchoscope']}], 'interventions': [{'name': 'Macintosh videolaryngoscope', 'type': 'DEVICE', 'description': 'Used to perform nasotracheal intubation under general anesthesia. The Macintosh videolaryngoscope is introduced orally to visualize the glottis, and a preformed nasotracheal tube is inserted through the nostril.', 'armGroupLabels': ['Videolaryngoscope Group']}, {'name': 'Flexible bronchoscope', 'type': 'DEVICE', 'description': 'Used to perform nasotracheal intubation under general anesthesia. The bronchoscope is inserted through a lubricated nasotracheal tube and advanced into the trachea.', 'armGroupLabels': ['Flexible Bronchoscope Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'KYUNG WON SHIN', 'role': 'CONTACT', 'email': 'skwskw126@gmail.com', 'phone': '02-2072-2469'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}