Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-01-07 @ 5:06 AM
Study NCT ID:
NCT02458794
Status:
UNKNOWN
Last Update Posted:
2015-07-29
First Post:
2015-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010979', 'term': 'Platelet Function Tests'}], 'ancestors': [{'id': 'D006403', 'term': 'Hematologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2015-05-20', 'studyFirstSubmitQcDate': '2015-05-29', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oropharyngeal seal pressure', 'timeFrame': '5 minutes', 'description': 'Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).'}], 'secondaryOutcomes': [{'measure': 'anatomic position', 'timeFrame': '5 minutes', 'description': 'The anatomic position was assessed by passing a fiberoptic scope through the airway tube stopping 0,5 cm prior to the end of the tube. The airway tube view was scored using an established scoring system.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Airway Morbidity']}, 'descriptionModule': {'briefSummary': 'The Ambu-Aura GainTM is a new extraglottic airway device which brings together features of both the LMA ProSealTM (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively) and the LMA UniqueTM (single use - prevention of disease transmission). In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the Ambu-Aura GainTM and the LMA SupremeTM in paralyzed, anesthetized patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 or 2\n* Age 19-65 yr\n* Written informed consent\n\nExclusion Criteria:\n\n* Difficult airway\n* Non fasted\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT02458794', 'briefTitle': 'Crossover Study of the LMA SupremeTM vs Ambu-Aura GainTM', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'A Randomized Crossover Study of the LMA SupremeTM Versus Ambu-Aura GainTM in Adult Patients', 'orgStudyIdInfo': {'id': 'Schulthess_Anä_5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LMA SupremeTM', 'description': 'function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion', 'interventionNames': ['Procedure: function tests', 'Device: LMA SupremeTM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ambu-Aura GainTM', 'description': 'function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion', 'interventionNames': ['Procedure: function tests', 'Device: Ambu-Aura GainTM']}], 'interventions': [{'name': 'function tests', 'type': 'PROCEDURE', 'description': 'ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion', 'armGroupLabels': ['Ambu-Aura GainTM', 'LMA SupremeTM']}, {'name': 'LMA SupremeTM', 'type': 'DEVICE', 'armGroupLabels': ['LMA SupremeTM']}, {'name': 'Ambu-Aura GainTM', 'type': 'DEVICE', 'armGroupLabels': ['Ambu-Aura GainTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39100', 'city': 'Bolzano', 'country': 'Italy', 'contacts': [{'name': 'Lukas Gasteiger, MD', 'role': 'CONTACT', 'email': 'Lukas.Gasteiger@sabes.it'}], 'facility': 'Zentralkrankenhaus Bozen', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Christian Keller, MD, M.Sc.', 'role': 'CONTACT', 'email': 'christian.keller@kws.ch', 'phone': '+41443857462'}], 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Christian Keller, MD MSc', 'role': 'CONTACT', 'email': 'christian.keller@kws.ch', 'phone': '++41443857462'}], 'overallOfficials': [{'name': 'Christian Keller, MD MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Schulthess Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'collaborators': [{'name': 'Krankenhaus Bozen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}