Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT02642367
Status:
COMPLETED
Last Update Posted:
2016-11-23
First Post:
2015-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stylet Use for McGrath Videolaryngoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-21', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-29', 'lastUpdatePostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': '2 min after rocuronium injection', 'description': 'time the blade passed the lips until endtidal CO2 was detected'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Orotracheal Intubation']}, 'descriptionModule': {'briefSummary': 'The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery\n\nExclusion Criteria:\n\n* cervical spine injury\n* rapid sequence induction\n* body mass index\\> 35 kg/m2\n* airway pathology'}, 'identificationModule': {'nctId': 'NCT02642367', 'briefTitle': 'Stylet Use for McGrath Videolaryngoscope', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'Comparison of With or Without Use of Stylet for Endotracheal Intubation With McGrath Videolaryngoscope', 'orgStudyIdInfo': {'id': 'AJIRB-MED-DE4-15-345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'no use of stylet', 'description': 'Endotracheal intubation was performed 2 min after rocuronium injection without use of stylet with McGrath videolaryngoscope after endotracheal tube was rolled up circularly for 3 min', 'interventionNames': ['Device: McGrath videolaryngoscope', 'Drug: rocuronium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'use of stylet', 'description': 'Endotracheal intubation was performed 2 min after rocuronium injection using a styletted endotracheal tube with McGrath videolaryngoscope', 'interventionNames': ['Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)', 'Drug: rocuronium']}], 'interventions': [{'name': 'McGrath videolaryngoscope', 'type': 'DEVICE', 'description': 'without use of stylet', 'armGroupLabels': ['no use of stylet']}, {'name': 'McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)', 'type': 'DEVICE', 'description': 'use of stylet', 'armGroupLabels': ['use of stylet']}, {'name': 'rocuronium', 'type': 'DRUG', 'otherNames': ['rocumeron'], 'description': 'tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope', 'armGroupLabels': ['no use of stylet', 'use of stylet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443-721', 'city': 'Suwon', 'state': 'Gyeongki-do', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}, {'zip': '443-721', 'city': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'Jong Yeop Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate profefssor', 'investigatorFullName': 'Jong Yeop Kim', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}