Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT02878005
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain
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': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-24', 'studyFirstSubmitDate': '2016-08-15', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to performe blind intubation measure in second', 'timeFrame': '30 seconds'}], 'secondaryOutcomes': [{'measure': 'Time to performe fiberoptic intubation in second', 'timeFrame': '60 seconds'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Intubating Laryngeal Tube', 'blind intubation', 'fiberoptic'], 'conditions': ['Intubation; Difficult']}, 'referencesModule': {'references': [{'pmid': '36445250', 'type': 'DERIVED', 'citation': 'Somri M, Hochman O, Gaitini L, Hossein J, Gomez-Rios MA. The intubating laryngeal tube (iLTS-D) versus Ambu(R) Auragain as a conduit facilitating fiberoptic tracheal intubation in adult population: results from a prospective randomized controlled trial. Minerva Anestesiol. 2022 Dec;88(12):1074-1076. doi: 10.23736/S0375-9393.22.16731-3. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube either blindly or with fiberoptic guidance.This study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients.', 'detailedDescription': 'The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM Medizintechnik GmbH, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction Disposable (LTS-D) It has a ventilator channel with a 13.5mm internal diameter, which enables the passage of an Endotracheal Tube (ETT) either blindly or with fiberoptic guidance. Similarly As in to the LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes placement up to a size of 18 Fr.\n\nThe iLTS-D comes in one size. According to the depth of insertion, this device is equivalent to size 4 for patients 175patients 175 to 190 cm tall, or size 5 for patients taller than 190 cm. The iLTS-D is provided by the manufacturer with a compatible 7.5mm ETT and with a plastic stabilizer for removal of the device.\n\nThe current randomized study was designed to assess the success rate of blind and fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under general anesthesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmerican Society Anesthesiology I and II\n\nExclusion Criteria:\n\nDifficult intubation, Cervical pathology'}, 'identificationModule': {'nctId': 'NCT02878005', 'briefTitle': 'A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'A Prospective and Randomized Study Comparing the New Intubating Laryngeal Tube Suction and the Ambu AuraGain in Adult Patients', 'orgStudyIdInfo': {'id': 'BnaiZionMC-16-LG-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intubating laryngeal Tube Suction', 'description': 'Intubating laryngeal Tube Suction', 'interventionNames': ['Device: Intubating Laryngeal Tube Suction', 'Device: Ambu AuraGain Laryngeal Mask']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ambu AuraGain Laryngeal Mask', 'description': 'Ambu AuraGain Laryngeal Mask', 'interventionNames': ['Device: Intubating Laryngeal Tube Suction', 'Device: Ambu AuraGain Laryngeal Mask']}], 'interventions': [{'name': 'Intubating Laryngeal Tube Suction', 'type': 'DEVICE', 'description': 'Intubating Laryngeal Tube Suction', 'armGroupLabels': ['Ambu AuraGain Laryngeal Mask', 'Intubating laryngeal Tube Suction']}, {'name': 'Ambu AuraGain Laryngeal Mask', 'type': 'DEVICE', 'description': 'Ambu AuraGain Laryngeal Mask', 'armGroupLabels': ['Ambu AuraGain Laryngeal Mask', 'Intubating laryngeal Tube Suction']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'LUIS.GAITINI', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}