Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-27 @ 1:07 PM
Study NCT ID:
NCT04482166
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2020-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2020-07-19', 'studyFirstSubmitQcDate': '2020-07-21', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elapsed time to succeed endotracheal intubation for each training period', 'timeFrame': 'From start of each training period to success of endotracheal intubation, not to exceed 10 minutes'}], 'secondaryOutcomes': [{'measure': 'Elapsed time to successful insertion of supraglottic airway device and ventilation of the manikin for each training period', 'timeFrame': 'From start of each training period to success of ventilation, not to exceed 10 minutes'}, {'measure': 'Elapsed time to identification of vocal cords via fiberoptic bronchoscope for each training period', 'timeFrame': 'From start of each training period to identification of vocal cords, not to exceed 10 minutes'}, {'measure': 'Elapsed time to introduction of fiberoptic bronchoscope into the trachea for each training period', 'timeFrame': 'From start of each training period to introduction of fiberoptic bronchoscope into the trachea, not to exceed 10 minutes'}, {'measure': 'Success rate of endotracheal intubation for each training period', 'timeFrame': 'From start of each training period to success of endotracheal intubation, not to exceed 10 minutes'}, {'measure': 'Number of trials', 'timeFrame': 'From start of each training period to success of endotracheal intubation, not to exceed 10 minutes', 'description': 'Number of trials to succeed ventilation, vocal cord identification, fiberoptic bronchoscope introduction, endotracheal intubation for each training period'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fiberoptic bronchoscope', 'Supraglottic airway'], 'conditions': ['Intubation;Difficult']}, 'referencesModule': {'references': [{'pmid': '32022437', 'type': 'BACKGROUND', 'citation': 'Stein ML, Park RS, Kovatsis PG. Emerging trends, techniques, and equipment for airway management in pediatric patients. Paediatr Anaesth. 2020 Mar;30(3):269-279. doi: 10.1111/pan.13814. Epub 2020 Feb 5.'}, {'pmid': '31887239', 'type': 'BACKGROUND', 'citation': 'Hunyady A, Polaner D. Pediatric airway management education and training. Paediatr Anaesth. 2020 Mar;30(3):362-370. doi: 10.1111/pan.13808. Epub 2020 Jan 16.'}, {'pmid': '25684039', 'type': 'BACKGROUND', 'citation': 'Black AE, Flynn PE, Smith HL, Thomas ML, Wilkinson KA; Association of Pediatric Anaesthetists of Great Britain and Ireland. Development of a guideline for the management of the unanticipated difficult airway in pediatric practice. Paediatr Anaesth. 2015 Apr;25(4):346-62. doi: 10.1111/pan.12615. Epub 2015 Feb 16.'}, {'pmid': '26956516', 'type': 'BACKGROUND', 'citation': 'Kovatsis PG. Continuous ventilation during flexible fiberscopic-assisted intubation via supraglottic airways. Paediatr Anaesth. 2016 Apr;26(4):457-8. doi: 10.1111/pan.12863. No abstract available.'}, {'pmid': '21710368', 'type': 'BACKGROUND', 'citation': 'Dalal PG, Dalal GB, Pott L, Bezinover D, Prozesky J, Bosseau Murray W. Learning curves of novice anesthesiology residents performing simulated fibreoptic upper airway endoscopy. Can J Anaesth. 2011 Sep;58(9):802-9. doi: 10.1007/s12630-011-9542-2. Epub 2011 Jun 28.'}, {'pmid': '30908421', 'type': 'BACKGROUND', 'citation': 'Altun D, Ozkan-Seyhan T, Camci E, Sivrikoz N, Orhan-Sungur M. Learning Curves for Two Fiberscopes in Simulated Difficult Airway Scenario With Cumulative Sum Method. Simul Healthc. 2019 Jun;14(3):163-168. doi: 10.1097/SIH.0000000000000368.'}, {'pmid': '28577552', 'type': 'BACKGROUND', 'citation': 'Oliveira KF, Arzola C, Ye XY, Clivatti J, Siddiqui N, You-Ten KE. Determining the amount of training needed for competency of anesthesia trainees in ultrasonographic identification of the cricothyroid membrane. BMC Anesthesiol. 2017 Jun 2;17(1):74. doi: 10.1186/s12871-017-0366-7.'}, {'pmid': '31583796', 'type': 'BACKGROUND', 'citation': 'Orhan-Sungur M, Altun D, Ozkan-Seyhan T, Aygun E, Koltka K, Camci E. Learning curve of ultrasound measurement of subglottic diameter for endotracheal tube selection in pediatric patients. Paediatr Anaesth. 2019 Dec;29(12):1194-1200. doi: 10.1111/pan.13751. Epub 2019 Oct 20.'}, {'pmid': '31426378', 'type': 'BACKGROUND', 'citation': 'Kim HJ, Park HS, Kim SY, Ro YJ, Yang HS, Koh WU. A Randomized Controlled Trial Comparing Ambu AuraGain and i-gel in Young Pediatric Patients. J Clin Med. 2019 Aug 16;8(8):1235. doi: 10.3390/jcm8081235.'}, {'pmid': '33329810', 'type': 'BACKGROUND', 'citation': 'Lee JH, Nam S, Jang YE, Kim EH, Kim HS, Kim JT. Clinical performance of Ambu AuraGainTM versus i-gelTM in anesthetized children: a prospective, randomized controlled trial. Anesth Pain Med (Seoul). 2020 Apr 30;15(2):173-180. doi: 10.17085/apm.2020.15.2.173. Epub 2020 Apr 29.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to obtain learning curve data of residents for fiberoptic-guided tracheal intubation through supraglottic airway device for pediatric difficult airway manikin.', 'detailedDescription': 'Residents under anesthesiology training will undergo a simulation practice to a pediatric airway manikin, after a single demonstration by an expert for fiberoptic-guided tracheal intubation through supraglottic airway device. The participants will do the same practice 20 times to the same manikin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residents under anesthesiology training with experience of more than 30 times of supraglottic airway device insertion and manipulation of fiberoptic bronchoscope\n\nExclusion Criteria:\n\n* Prior experience of fiberoptic-guided tracheal intubation through supraglottic airway device\n* Prior experience of training for fiberoptic-guided tracheal intubation through supraglottic airway device'}, 'identificationModule': {'nctId': 'NCT04482166', 'briefTitle': 'Learning Curve of Fiberoptic Intubation Through Supraglottic Airway Device', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Learning Curve of Fiberoptic-guided Tracheal Intubation Through Supraglottic Airway Device for Pediatric Difficult Airway Manikin', 'orgStudyIdInfo': {'id': '2006-160-1135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Candidates', 'description': 'Training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin', 'interventionNames': ['Other: Training', 'Device: supraglottic airway device']}], 'interventions': [{'name': 'Training', 'type': 'OTHER', 'description': '20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin', 'armGroupLabels': ['Candidates']}, {'name': 'supraglottic airway device', 'type': 'DEVICE', 'description': 'supraglottic airway device', 'armGroupLabels': ['Candidates']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Other', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji-Hyun Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor', 'investigatorFullName': 'Ji-Hyun Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}