Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT04153357
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2019-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study
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', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-17', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-04', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intubation time', 'timeFrame': '30 seconds', 'description': 'device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['airtraq', 'c-mac', 'videolaryngoscope', 'infant', 'intubatioon'], 'conditions': ['Intubation;Difficult']}, 'descriptionModule': {'briefSummary': 'İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.', 'detailedDescription': 'Aim:İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.\n\nmethods: We enroll total 50 patients \\< 1 year old undergoing neurosurgery. We compared the intubation times, success rates and minor complications of Airtraq and c-mac video laryngoscopes in these pediatric patients undergoing neurosurgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\< 1 years old\n\n* undergoing neurosurgery ASA 1-2\n\nExclusion Criteria:\n\n* \\> 1 year old\n* asa 3-4\n* emergency'}, 'identificationModule': {'nctId': 'NCT04153357', 'briefTitle': 'Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Comparison of Airtraq and C-mac in Pediatric Patients Under 1 Year Old', 'orgStudyIdInfo': {'id': 'KOU KAEK 2016/315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intubation time airtraq', 'description': 'intubation time of Airtraq', 'interventionNames': ['Device: airtraq']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intubation time of c-mac', 'description': 'intubation time of c-mac', 'interventionNames': ['Device: c-mac']}], 'interventions': [{'name': 'airtraq', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords', 'armGroupLabels': ['intubation time airtraq']}, {'name': 'c-mac', 'type': 'DEVICE', 'otherNames': ['videolaryngoscope'], 'description': 'device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords', 'armGroupLabels': ['intubation time of c-mac']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Medical Faculty', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Zehra Ipek ARSLAN', 'investigatorAffiliation': 'Kocaeli University'}}}}