Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-04-20 @ 2:44 AM
Study NCT ID:
NCT03156166
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Distance From the Glottis to the Grille in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-15', 'lastUpdatePostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The distance from grille to glottis', 'timeFrame': '30 seconds after each supraglottic airway insertion', 'description': 'The distance from grille to glottis is measured using fiberoptic bronchoscopy'}], 'secondaryOutcomes': [{'measure': 'FOB view', 'timeFrame': '30 seconds after each supraglottic airway insertion', 'description': 'score 1: no visible glottis, score 2: visible glottis and anterior epiglottis, score 3: visible glottis and posterior epiglottis, and score 4: only glottis visible'}, {'measure': 'Ventilation score', 'timeFrame': '30 seconds after each supraglottic airway insertion', 'description': 'no air leak in airway pressure of 15 cmH2O / bilateral chest wall movement/ normal waveform of capnography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '31415305', 'type': 'DERIVED', 'citation': 'Lee JH, Park S, Jang YE, Kim EH, Kim HS, Kim JT. The distance between the glottis and the cuff of a tracheal tube placed through three supraglottic airway devices in children: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):721-727. doi: 10.1097/EJA.0000000000001070.'}]}, 'descriptionModule': {'briefSummary': 'Ambu AuraGain, I-gel, Air-Q intubating laryngeal airway are the most commonly used supraglottic airway. In children, they can be used as intubation conduits. However, there has been no guideline for optimal insertion depth of endotracheal tube through those supraglottic airway. In this study, the investigators will measure the distance from grille of those supraglottic airways to glottis using fiberoptic bronchoscope in children undergoing anesthesia. This distance allows us to predict an appropriate depth of endotracheal tube when it should be inserted through each supraglottic airway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children \\< 7 years old undergoing elective surgery\n\nExclusion Criteria:\n\n* difficult airway\n* BMI\\> 30kg/m2\n* emergency operation\n* cervical spine disease\n* history of esophageal disease and surgery'}, 'identificationModule': {'nctId': 'NCT03156166', 'briefTitle': 'Distance From the Glottis to the Grille in Children', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Distance From the Glottis to the Grille in Children: Ambu AuraGainTM , I-gel, Air-Q Intubating Laryngeal Airway as Intubation Conduits', 'orgStudyIdInfo': {'id': 'H1704-133-848'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ambu AuraGain', 'description': 'Ambu AuraGain is inserted in children undergoing general anesthesia. The size of AuraGain is as follows: size 1 for children \\<5 kg, size 1.5 for 5-10kg, size 2 for 10-20kg, size 2.5 for 20-30kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord.', 'interventionNames': ['Procedure: fiberoptic bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'I-gel', 'description': 'I-gel is inserted in children undergoing general anesthesia. The size of I-gel is as follows: size 1 for children weighing 2-5kg, size 1.5 for 5-12kg, size 2 for 10-25kg, size 2.5 for 25-35kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord.', 'interventionNames': ['Procedure: fiberoptic bronchoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Air-Q intubating laryngeal airway (ILA)', 'description': 'Air-Q ILA is inserted in children undergoing general anesthesia. The size of Air-Q ILA is as follows: size 1 for children between 4-7 kg, size 1.5 for 7-17kg, size 2 for 17-30kg, size 2.5 for 30-50kg. Fiberoptic bronchoscope will be performed to measure the distance between the grill and vocal cord.', 'interventionNames': ['Procedure: fiberoptic bronchoscope']}], 'interventions': [{'name': 'fiberoptic bronchoscope', 'type': 'PROCEDURE', 'otherNames': ['FOB'], 'description': 'Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB', 'armGroupLabels': ['Air-Q intubating laryngeal airway (ILA)', 'Ambu AuraGain', 'I-gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}