Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-13 @ 2:44 PM
Study NCT ID:
NCT02820792
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2016-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Crossover Study of the LMA Protector Versus Ambu AuraGain
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2016-06-29', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'oropharyngeal leak pressure', 'timeFrame': '5 min', '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 min', '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 LMA ProtectorTM 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 study the investigators test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProtectorTM and the Ambu AuraGainTM 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': 'NCT02820792', 'briefTitle': 'Non-Crossover Study of the LMA Protector Versus Ambu AuraGain', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'A Randomized Non-Crossover Study of the LMA ProtectorTM Versus Ambu Aura GainTM in Adult Patients', 'orgStudyIdInfo': {'id': 'Schulthess_Anä_8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LMA ProtectorTM', '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 ProtectorTM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ambu AuraGainTM', '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 AuraGainTM']}], 'interventions': [{'name': 'function tests', 'type': 'PROCEDURE', 'description': 'function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion', 'armGroupLabels': ['Ambu AuraGainTM', 'LMA ProtectorTM']}, {'name': 'LMA ProtectorTM', 'type': 'DEVICE', 'armGroupLabels': ['LMA ProtectorTM']}, {'name': 'Ambu AuraGainTM', 'type': 'DEVICE', 'armGroupLabels': ['Ambu AuraGainTM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Schulthess Klinik', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Christian Keller MD, M.Sc.', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Berthold Moser, MD MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}