Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT03086668
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fingers Hook Technique to Facilitate Nasotracheal Intubation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-19', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-03-15', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'grade of glottic field exposure and nasotracheal difficulty intubation score', 'timeFrame': 'half an hour', 'description': 'to compare the two different techniques in glottic field exposure and score of nasotracheal difficulty intubations scale'}], 'secondaryOutcomes': [{'measure': 'the tube-videostylet assembly range of motion', 'timeFrame': 'half an hour', 'description': 'range motion of tip of tube-videostylet assembly advanced from nasal cavity to trachea'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nasotracheal Intubation', 'jaw thrust', 'hook-finger'], 'conditions': ['Nasotracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '19100929', 'type': 'BACKGROUND', 'citation': 'Cheng KI, Yun MK, Chang MC, Lee KW, Huang SC, Tang CS, Chen CH. Fiberoptic bronchoscopic view change of laryngopharyngeal tissues by different airway supporting techniques: comparison of patients with and without open mouth limitation. J Clin Anesth. 2008 Dec;20(8):573-9. doi: 10.1016/j.jclinane.2008.01.013.'}]}, 'descriptionModule': {'briefSummary': 'to compare either using conventional jaw thrust technique or with a novel fingers-hook technique to facilitate video-stylet assisted nasotracheal intubation', 'detailedDescription': 'It is necessary to adequately exposure of glottis during naso-tracheal intubation using video-stylet. However, inadequate upward epiglottis or over-elevation of arytenoids all inhibit the tube tip smoothly into trachea. Therefore, the study is to investigate either jaw thrust or fingers-hook technique is advantages of nasotracheal intubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Criteria:\n\nInclusion Criteria:\n\n1. patients with American Society of Anesthesiologists physical status I-III\n2. aged 20-65 years\n3. Requiring general anesthesia undergoing oxo-maxillofacial surgery\n4. unlimited mouth open\n5. unlimited neck motion\n\nExclusion Criteria:\n\n1. mouth open \\< 3 cm\n2. Ankylosing arthritis patients.\n3. BMI≧35 kg/m2'}, 'identificationModule': {'nctId': 'NCT03086668', 'briefTitle': 'Fingers Hook Technique to Facilitate Nasotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Tube-Videostylet Assembly for Nasotracheal Intubation Assisted by a Fingers-Hook Technique', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20160019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional Jaw thrust Group', 'description': 'an assembly of video-stylet and double curve endotracheal tube with conventional jaw thrust technique to facilitate nasotracheal intubation', 'interventionNames': ['Procedure: Conventional Jaw thrust Group']}, {'type': 'EXPERIMENTAL', 'label': 'Fingers hook Group', 'description': 'an assembly of video-stylet and double curve endotracheal tube with fingers-hook technique to facilitate nasotracheal intubation', 'interventionNames': ['Procedure: Fingers hook Group']}], 'interventions': [{'name': 'Conventional Jaw thrust Group', 'type': 'PROCEDURE', 'description': 'a video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique', 'armGroupLabels': ['Conventional Jaw thrust Group']}, {'name': 'Fingers hook Group', 'type': 'PROCEDURE', 'description': 'a video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique', 'armGroupLabels': ['Fingers hook Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung Medical University', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Kuang I Cheng, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University,Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}