Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT05607433
Status:
UNKNOWN
Last Update Posted:
2022-11-07
First Post:
2019-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation
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'], 'maskingDescription': 'only participants will be masked'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized comparative study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-09-13', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'postoperative hoarseness of voice', 'timeFrame': '2 hours postoperative', 'description': 'change of voice'}], 'primaryOutcomes': [{'measure': 'Total endotracheal intubation time', 'timeFrame': 'time of tube exchanger insertion and endotracheal tube insertion', 'description': 'tube exchanger intubation time plus endotracheal intubation time'}], 'secondaryOutcomes': [{'measure': 'success rate of endotracheal intubation', 'timeFrame': '1 second after insertion tube exchanger until successful endotracheal intubation', 'description': 'incidence of successful endotracheal intubation'}, {'measure': 'Tube exchanger insertion time', 'timeFrame': 'from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea', 'description': 'time from disconnection of the supraglottic device from ventilator to successful insertion of tube exchanger in trachea'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['assisted intubation'], 'conditions': ['Difficult Intubation']}, 'referencesModule': {'references': [{'pmid': '21320087', 'type': 'BACKGROUND', 'citation': 'Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.'}, {'pmid': '20369770', 'type': 'BACKGROUND', 'citation': 'Bakker EJ, Valkenburg M, Galvin EM. Pilot study of the air-Q intubating laryngeal airway in clinical use. Anaesth Intensive Care. 2010 Mar;38(2):346-8. doi: 10.1177/0310057X1003800217.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to compare the efficacy of the Ambu AuraGain to that of the Air Q ILA as a conduit for endotracheal intubation assisted by tube exchanger. The comparison will be in terms of total intubation time, success rate of insertion of the tube exchanger as well as endotracheal intubation and complications.', 'detailedDescription': 'Very few studies discussed assisted endotrachealc intubation using certain tools as bougie through the Air Q ILA .\n\nthe hypothesis in this study is that the use of flexible, small calibre tube exchanger introduced through both supraglottic devices into the trachea as guidance for endotracheal intubation, will have shorter intubation time with the Ambu AuraGain than the Air Q ILA and less complications in both devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age : 18 to 60\n* ASA physical status 1 and 2\n* body weight less than 90 kilos\n* Ganzouri airway score less than or equal to 3.\n\nExclusion Criteria:\n\n* Active respiratory or cardiac disease\n* Any expected airway difficulties\n* Craniofacial abnormalities or fractures\n* patients with abnormal coagulation profile'}, 'identificationModule': {'nctId': 'NCT05607433', 'briefTitle': 'Air Q Laryngeal Airway Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Air Q Intubating Laryngeal Airway (Air QILA) Versus the AmbuAura Gain as a Conduit for Endotracheal Intubation Assisted by Tube Exchanger, a Randomized Comparative Study.', 'orgStudyIdInfo': {'id': 'supraglottic devices'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air Q ILA group', 'description': 'Air Q supraglottic device will be placed in the participants in this group .', 'interventionNames': ['Device: cook ®Airway Exchanger Catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Ambu AuraGain group', 'description': 'Ambu AuraGain supraglottic device will be placed in the participants in this group .', 'interventionNames': ['Device: cook ®Airway Exchanger Catheter']}], 'interventions': [{'name': 'cook ®Airway Exchanger Catheter', 'type': 'DEVICE', 'description': 'A tube exchanger is a small calibre , flexible tube used to guide endotracheal intubation through a supraglottic device.', 'armGroupLabels': ['Air Q ILA group', 'Ambu AuraGain group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11559', 'city': 'Cairo', 'state': 'Elmanial', 'country': 'Egypt', 'facility': 'Kasr Alainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Hoda Alrify', 'role': 'CONTACT', 'email': 'hodazakariasaleh@outlook.com', 'phone': '002 01004226722'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of anesthesia', 'investigatorFullName': 'Hoda Zakaria Saleh Hassan Alrify', 'investigatorAffiliation': 'Cairo University'}}}}