Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2026-02-19 @ 5:51 AM
Study NCT ID:
NCT02478203
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2015-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2015-04-17', 'studyFirstSubmitQcDate': '2015-06-22', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': '120 seconds', 'description': 'handling of the device till visualization of the tube entering through the vocal cords'}], 'secondaryOutcomes': [{'measure': 'need of maneuvers (mender applied or not)', 'timeFrame': 'intraoperative', 'description': 'maneuver applied or not'}, {'measure': 'esophageal intubation (eosophageal intubation occured or not)', 'timeFrame': 'intraoperative', 'description': 'eosophageal intubation occured or not'}, {'measure': 'intubation attempts (is it increased or not)', 'timeFrame': 'intraoperative', 'description': 'the patient intubated at which attempt?'}, {'measure': 'cormack-lehane grade (which one improves the cormack- lehane grade)', 'timeFrame': 'intraoperative'}, {'measure': 'insertion time', 'timeFrame': '30 seconds', 'description': 'handling of the device till the glottic visualization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Airtraq', 'Glidescope', 'pediatric', 'face-to-face'], 'conditions': ['Difficult Intubation']}, 'descriptionModule': {'briefSummary': 'After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq, Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models.', 'detailedDescription': 'After Local Human Research Ethics Committee approval, emergency medical staff enrolled in this study. After watching a video about the intubation using Airtraq , Glidescope or direct laryngoscopy, they attempted to intubate a pediatric manikin in three different airway models; normal airway, tongue edema and an entrapped model by face-to-face approach. Intubation attempts, insertion and intubation times, success rates, Cormack-Lehane grades and the need for maneuvers of these devices were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric\n\nExclusion Criteria:\n\n* adult'}, 'identificationModule': {'nctId': 'NCT02478203', 'briefTitle': 'Intubation on a Paediatric Manikin by Emergency Staff: a Comparison of Airtraq and Glidescope', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Intubation on a Pediatric Manikin by Emergency Medical Staff: a Comparison of Direct Laryngoscopy, Airtraq and Glidescope in Normal, Tongue Edema and Face-to-face Intubation Models', 'orgStudyIdInfo': {'id': 'KOU KAEK 2014/108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'normal', 'description': 'intubation of a normal airway pediatric manikin with direct laryngoscopy, airtraq , glidescope', 'interventionNames': ['Device: Airtraq', 'Device: Glidescope', 'Device: direct laryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'tongue edema', 'description': 'intubation of a tongue edema simulated pediatric manikin with diract laryngoscopy, glidescope and airtraq', 'interventionNames': ['Device: Airtraq', 'Device: Glidescope', 'Device: direct laryngoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'face-to-face intubation', 'description': 'intubation of an entrapped pediatric manikin with diract laryngoscopy, glidescope and airtraq', 'interventionNames': ['Device: Airtraq', 'Device: Glidescope']}], 'interventions': [{'name': 'Airtraq', 'type': 'DEVICE', 'description': 'videolaryngoscope for difficult airway', 'armGroupLabels': ['face-to-face intubation', 'normal', 'tongue edema']}, {'name': 'Glidescope', 'type': 'DEVICE', 'description': 'videolaryngoscope for difficult airway', 'armGroupLabels': ['face-to-face intubation', 'normal', 'tongue edema']}, {'name': 'direct laryngoscopy', 'type': 'DEVICE', 'description': 'gold standart for intubation', 'armGroupLabels': ['normal', 'tongue edema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41900', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University School of Medicine', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Zehra I Arslan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Anesthesiology and Reanimation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}