Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
Study NCT ID:
NCT06655168
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2024-10-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy
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': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time taken for successful tracheal intubation', 'timeFrame': 'during intubation'}], 'secondaryOutcomes': [{'measure': 'the need for additional device', 'timeFrame': 'during intubation'}, {'measure': 'the number of attempts', 'timeFrame': 'during intubation'}, {'measure': 'Complications during intubation', 'timeFrame': 'during intubation', 'description': 'complications such as desaturation and selective intubation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endotracheal intubation, newborn, direct laryngoscopy,video laryngoscopy'], 'conditions': ['The Time Taken for Successful Tracheal Intubation in Each Technique']}, 'descriptionModule': {'briefSummary': 'The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group)', 'detailedDescription': 'prospective randomized study including newborns , requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit. The children were randomized into two groups to receive orotracheal intubation after anesthetic induction with neuromuscular blockade, either by direct laryngoscopy (DL, DL group) or by C-MAC video laryngoscopy (VL group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '1 Minute', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newborns requiring orotracheal intubation for surgery or mechanical ventilation in the intensive care unit\n\nExclusion Criteria:\n\n* age\\> 01 month'}, 'identificationModule': {'nctId': 'NCT06655168', 'briefTitle': 'Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Orotracheal Intubation in Newborns: Videolaryngoscopy Vs Direct Laryngoscopy', 'orgStudyIdInfo': {'id': '212023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Video laryngoscopy', 'interventionNames': ['Device: Video Laryngoscopy']}, {'type': 'OTHER', 'label': 'Direct laryngoscopy', 'interventionNames': ['Device: Direct Laryngoscopy']}], 'interventions': [{'name': 'Video Laryngoscopy', 'type': 'DEVICE', 'description': 'orotracheal intubation by C-Mac ( Video laryngoscopy)', 'armGroupLabels': ['Video laryngoscopy']}, {'name': 'Direct Laryngoscopy', 'type': 'DEVICE', 'description': 'Orotracheal intubation using Direct Laryngoscopy', 'armGroupLabels': ['Direct laryngoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2001', 'city': 'Tunis', 'state': 'Tunis Governorate', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'salma Aouadi', 'role': 'CONTACT', 'email': 'salmaaouadi1@gmail.com', 'phone': '0021656652210'}], 'facility': 'Bechir Hamza hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'salma Aouadi, Hospital university assistant', 'role': 'CONTACT', 'email': 'salmaaouadi1@gmail.com', 'phone': '0021656652210'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesia and Intensive Care Department', 'investigatorFullName': 'Mehdi Trifa', 'investigatorAffiliation': 'Tunis University'}}}}