Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT03480035
Status:
COMPLETED
Last Update Posted:
2018-12-21
First Post:
2018-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014313', 'term': 'Trismus'}, {'id': 'D014071', 'term': 'Tooth Abnormalities'}], 'ancestors': [{'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-03-21', 'studyFirstSubmitQcDate': '2018-03-21', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'distance from lightbeam of the FOB to thyroid cartilage', 'timeFrame': 'before intubation', 'description': "we will measure straight distance from lightbeam of the FOB to thyroid cartilage on the surface of patient's neck"}, {'measure': 'distance from lightbeam of the FOB to cricoid cartilage', 'timeFrame': 'before intubation', 'description': "we will measure straight distance from lightbeam of the FOB to cricoid cartilage on the surface of patient's neck"}], 'secondaryOutcomes': [{'measure': 'distance from lightbeam of the FOB to sternal notch', 'timeFrame': 'before intubation', 'description': "we will measure straight distance from lightbeam of the FOB to sternal notch on the surface of patient's neck"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Disease', 'Trismus', 'Tooth Abnormalities']}, 'referencesModule': {'references': [{'pmid': '33284717', 'type': 'DERIVED', 'citation': 'Cho E, Kim HC, Lee JM, Park JH, Ha N, Hong JH, Lee J. Evaluation of transmitted glow point at a priori chosen depth (1 cm below vocal cords) for lightwand intubation: a prospective observational study. J Int Med Res. 2020 Dec;48(12):300060520974249. doi: 10.1177/0300060520974249.'}]}, 'descriptionModule': {'briefSummary': "If the patients's teeth are weak or the mouth dose not open well, the lightwand is a useful device when endotracheal intubation is necessary.\n\nTherefore, if the appropriate position of the light beam is determined and the distance of the light source suitable for intubation using the lightwand is obtained from anatomical structures such as thyroid cartilage and cricoid cartilage, it is clinically useful. Because it can prevent unnecessary deep insertion or shallow insertion that can cause damage to anatomical structures during intubation.", 'detailedDescription': "Studies have been reported on the proper position to bend the lightwand and the appropriate angle to bend when performing endotracheal intubation with lightwand. For ease of procedure, the assistant has to lift the patient's lower jaw or perform a neck extension.\n\nHowever, there is no report on the position of the lightbulb when the light passes through the front of the airway and neck and appears bright in the midpoint.\n\nThe prodcedure is as follows.\n\n1. FOB examination and check position of light below 1cm from vocal cord\n2. lightwand intubation aimed at checkpoint\n3. measurement of distance from thyroid cartilage/cricoid cartilage to light point"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This is an adult patient who is 18 years of age or older who undergoes general anesthesia requiring intubation.\n\nAmong them, patients who are unable to extend their necks, have trismus or have weak teeth are selected.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impossibility of neck extension\n* trismus\n* weak teeth\n\nExclusion Criteria:\n\n* previous history of larynx or neck surgery\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT03480035', 'briefTitle': 'Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand', 'organization': {'class': 'OTHER', 'fullName': 'Keimyung University Dongsan Medical Center'}, 'officialTitle': 'Ideal Point of Transluminal Light in Tracheal Intubation With a Light Wand', 'orgStudyIdInfo': {'id': 'lightwand intubation'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lightwand intubation', 'type': 'PROCEDURE', 'description': 'intubation using lightwand'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Dongsan medical center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Jiwon Lee, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongsan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Jiwon Lee', 'investigatorAffiliation': 'Keimyung University Dongsan Medical Center'}}}}