Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT03693235
Status:
COMPLETED
Last Update Posted:
2020-10-05
First Post:
2018-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adequate Bending Angle of a Lightwand
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', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-01', 'studyFirstSubmitDate': '2018-09-30', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sore throat', 'timeFrame': 'After surgery', 'description': 'After surgery, investigators evaluate VAS score for sore throat of the patients.'}, {'measure': 'Intubation time', 'timeFrame': 'Intraoperative', 'description': 'from initiation of tracheal intubation with a lightwand after bending it to completion of tracheal intubation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tracheal Intubation', 'Lightwand'], 'conditions': ['Tracheal Intubation']}, 'referencesModule': {'references': [{'pmid': '11444456', 'type': 'BACKGROUND', 'citation': 'Agro F, Hung OR, Cataldo R, Carassiti M, Gherardi S. Lightwand intubation using the Trachlight: a brief review of current knowledge. Can J Anaesth. 2001 Jun;48(6):592-9. doi: 10.1007/BF03016838.'}, {'pmid': '22971505', 'type': 'BACKGROUND', 'citation': 'Chen J, Luo W, Wang E, Lu K. Optimal bent length of lightwand for intubation in adults: a randomized, prospective, comparative study. J Int Med Res. 2012;40(4):1519-31. doi: 10.1177/147323001204000432.'}, {'pmid': '10702469', 'type': 'BACKGROUND', 'citation': 'Davis L, Cook-Sather SD, Schreiner MS. Lighted stylet tracheal intubation: a review. Anesth Analg. 2000 Mar;90(3):745-56. doi: 10.1097/00000539-200003000-00044. No abstract available.'}, {'pmid': '26647074', 'type': 'BACKGROUND', 'citation': 'Kim J, Im KS, Lee JM, Ro J, Yoo KY, Kim JB. Relevance of radiological and clinical measurements in predicting difficult intubation using light wand (Surch-lite) in adult patients. J Int Med Res. 2016 Feb;44(1):136-46. doi: 10.1177/0300060515594193. Epub 2015 Dec 7.'}, {'pmid': '8267162', 'type': 'BACKGROUND', 'citation': 'Szigeti CL, Baeuerle JJ, Mongan PD. Arytenoid dislocation with lighted stylet intubation: case report and retrospective review. Anesth Analg. 1994 Jan;78(1):185-6. doi: 10.1213/00000539-199401000-00034. No abstract available.'}, {'pmid': '34000987', 'type': 'DERIVED', 'citation': 'Won D, Lee JM, Lee J, Hwang JY, Kim TK, Chang JE, Kim H, Ma S, Min SW. A pilot study comparing three bend angles for lighted stylet intubation. BMC Anesthesiol. 2021 May 17;21(1):148. doi: 10.1186/s12871-021-01369-8.'}]}, 'descriptionModule': {'briefSummary': 'For tracheal intubation with a lightwand, adequate bending angle was not exactly investigated. The purpose of the study is compare three bending angles of lightwands for safe and efficient tracheal intubation.', 'detailedDescription': 'Lightwands are very useful device for difficult airway management due to small moth opening, weak teeth, and cervical spine instability. Experienced clinicians use a lightwand while bending it adequately. However, there has been not previous studies to investigate the adequate angle to bend it.\n\nThis randomized controlled trial is to compare three angles (70, 80, and 90 degrees) as bending angle of lightwands for safe and efficient tracheal intubation in cases which require the use of lightwands.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who require use of a lightwand for tracheal tubes (i.e. small mouth opening, weak teeth, cervical spine instability)\n\nExclusion Criteria:\n\n* patients who refuse to participate the study'}, 'identificationModule': {'nctId': 'NCT03693235', 'briefTitle': 'Adequate Bending Angle of a Lightwand', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Adequate Bending Angle of a Lightwand for Tracheal Intubation', 'orgStudyIdInfo': {'id': '30-2018-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '70 degrees', 'description': 'During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 70 degrees.', 'interventionNames': ['Procedure: bending angle of a lightwand']}, {'type': 'EXPERIMENTAL', 'label': '80 degrees', 'description': 'During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 80 degrees.', 'interventionNames': ['Procedure: bending angle of a lightwand']}, {'type': 'EXPERIMENTAL', 'label': '90 degrees', 'description': 'During tracheal intubation using a lightwand, the tracheal tube combined with a lightwand will be bent by 90 degrees.', 'interventionNames': ['Procedure: bending angle of a lightwand']}], 'interventions': [{'name': 'bending angle of a lightwand', 'type': 'PROCEDURE', 'description': 'For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient. Next a practitioner will perform tracheal intubation with the bent tube.', 'armGroupLabels': ['70 degrees', '80 degrees', '90 degrees']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Metropolitan Government Seoul National University Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jung-Man Lee, M.D., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SMG-SNU Boramae Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jung-Man Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}