Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-03 @ 6:58 PM
Study NCT ID:
NCT02977559
Status:
UNKNOWN
Last Update Posted:
2016-12-01
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients
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': '2017-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leak pressure measure in cm H2O', 'timeFrame': '60 seconds'}], 'secondaryOutcomes': [{'measure': 'Time to insertion a device in seconds', 'timeFrame': '60 seconds'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laryngeal Tube Suction Ambu AuraGain Leak Pressure'], 'conditions': ['Adverse Anesthesia Outcome']}, 'descriptionModule': {'briefSummary': 'The study compared the Laryngeal Tube Suction Disposable (LTS-D) with the Disposable Laryngeal Mask Ambu® AuraGain™ (DLMA AG) during general anesthesia in pediatric patients.\n\nThe investigators hypothesized that the LTS-D and the DLMA AG performed similarly during mechanical ventilation despite differences in their structural design.', 'detailedDescription': 'The Laryngeal Tube Suction-Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), is a second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.\n\nThe AuraGain is a second generation laryngeal mask, satisfying airway management needs by integrating gastric access and ventilation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway.\n\nThe two devices have now pediatric sizes.\n\nTo date, there is no published data comparing the LTS-D and the DLMA AG during mechanical ventilation in pediatric patients. The investigators hypothesized that the LTS-D and the DLMA AG perform similarly during mechanical ventilation despite differences in their structural design.\n\nThe chief aim of this prospective randomized study was to compare the LTS-D and the DLMA AG with respect to:\n\n1. time to achieve an effective airway,\n2. ease of insertion,\n3. need for interventions to achieve an effective airway,\n4. cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O,\n5. ventilatory variables during mechanical ventilation,\n6. fiberoptic score,\n7. gastric tube insertion and\n8. adverse perioperative events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients, American Society of Anesthesiologist (ASA) physical status I and II weighing 30 to 10 kg, posted for abdominal surgery under general anesthesia.\n\nExclusion Criteria:\n\n* Infants with active respiratory tract infection anticipated and known difficult airway, lung disease requiring high positive end expiratory pressure, and active gastrointestinal reflux will be excluded.'}, 'identificationModule': {'nctId': 'NCT02977559', 'briefTitle': 'A Study Between the Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bnai Zion Medical Center'}, 'officialTitle': 'A Comparative Randomized Prospective Study Between the New Laryngeal Tube Suction-Disposable and the Ambu AuraGain in Pediatric Patients', 'orgStudyIdInfo': {'id': 'BnaiZionMC-16-LG-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laryngeal Tube Suction Disposable', 'description': 'Laryngeal Tube Suction Disposable for ventilation', 'interventionNames': ['Device: Laryngeal Tube Suction Disposable']}, {'type': 'EXPERIMENTAL', 'label': 'Laryngeal Mask Airway AuraGain', 'description': 'Laryngeal Mask Airway AuraGain for oxygenation and ventilation', 'interventionNames': ['Device: Laryngeal Mask Airway AuraGain']}], 'interventions': [{'name': 'Laryngeal Tube Suction Disposable', 'type': 'DEVICE', 'description': 'Device for ventilation', 'armGroupLabels': ['Laryngeal Tube Suction Disposable']}, {'name': 'Laryngeal Mask Airway AuraGain', 'type': 'DEVICE', 'description': 'Ventilation device', 'armGroupLabels': ['Laryngeal Mask Airway AuraGain']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bnai Zion Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'LUIS.GAITINI', 'investigatorAffiliation': 'Bnai Zion Medical Center'}}}}