Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-01-17 @ 1:51 AM
Study NCT ID:
NCT03740620
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2018-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004844', 'term': 'Epistaxis'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-01', 'studyFirstSubmitDate': '2018-11-02', 'studyFirstSubmitQcDate': '2018-11-11', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of the tube in lower pathway', 'timeFrame': 'right after completion of the intubation', 'description': 'incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril)'}], 'secondaryOutcomes': [{'measure': 'intubation time', 'timeFrame': 'from the start of the intubation to the completion of the intubation, which is confirmed by the appearance of end-tidal CO2 curve, up to 60 seconds', 'description': 'time to complete endotracheal intubation'}, {'measure': 'incidence and severity of epistaxis', 'timeFrame': 'right after completion of the intubation', 'description': 'incidence and severity of epistaxis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['epistaxis'], 'conditions': ['Epistaxis', 'Intubation Complication']}, 'referencesModule': {'references': [{'pmid': '33009189', 'type': 'DERIVED', 'citation': 'Won D, Kim H, Chang JE, Lee JM, Min SW, Jung J, Yang HJ, Hwang JY, Kim TK. Effect of bevel direction on the tracheal tube pathway during nasotracheal intubation: A randomised trial. Eur J Anaesthesiol. 2021 Feb 1;38(2):157-163. doi: 10.1097/EJA.0000000000001347.'}]}, 'descriptionModule': {'briefSummary': "In this study, the subjects are divided into two groups (group I: intervention group = the nasotracheal tube inserted with the bevel of the nasal tube facing the direction of the patient's head, and Group II: conventional group = the bevel of the tube toward the left side of the subject). After the endotracheal tube is introduced, a flexible endoscope is used to evaluate whether the tube is located below the inferior turbinate, i.e. in the lower pathway.", 'detailedDescription': 'Primary outcome\n\n* incidence of tracheal tube passing through the lower pathway (beneath the inferior turbinate and immediately above the nasal floor of the nostril) Secondary outcome\n* intubation time\n* incidence of epistaxis\n* severity of bleeding\n* Resistance during Insertion of the tracheal tube'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* a patient who will take operation which needs nasotracheal intubation under general anesthesia\n\nExclusion Criteria:\n\n* a patient who didn't agree to participate in this study\n* a patient who has a deformity of the nose\n* a patient who has a history of severe epistaxis\n* a patient who has coagulation problem\n* a patient who has a history of the fracture or surgery of the skull base"}, 'identificationModule': {'nctId': 'NCT03740620', 'briefTitle': 'The Effect of Bevel Direction on the Pathway of the Nasotracheal Tube', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Bevel Direction on the Pathway of the Tracheal Tube in the Nasal Cavity During Nasotracheal Intubation: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '30-2018-76'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intervention group', 'description': 'In the intervention group, a nasotracheal tube is inserted into the nostril with the bevel of the tube facing the cephalad direction of the patient.', 'interventionNames': ['Procedure: Bevel facing the cephalad direction of the patient']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional group', 'description': 'In the conventional group, a nasotracheal tube is inserted in a usual way, i.e., with the bevel of the tube facing the left side of the patient.', 'interventionNames': ['Procedure: Bevel facing leftward of the patient']}], 'interventions': [{'name': 'Bevel facing the cephalad direction of the patient', 'type': 'PROCEDURE', 'description': 'The bevel of the nasotracheal tube facing cephalad direction of the patient', 'armGroupLabels': ['intervention group']}, {'name': 'Bevel facing leftward of the patient', 'type': 'PROCEDURE', 'description': 'The bevel of the nasotracheal tube facing the left side of the patient', 'armGroupLabels': ['conventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Tae Kyong Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}