Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-03-06 @ 10:12 PM
Study NCT ID:
NCT00626951
Status:
COMPLETED
Last Update Posted:
2008-07-03
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-25', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2008-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure', 'timeFrame': '5 min'}], 'secondaryOutcomes': [{'measure': 'Ease of insertion', 'timeFrame': '1 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LMA Supreme', 'LMA ProSeal', 'Laryngeal mask airway', 'Ventilation'], 'conditions': ['Paralysis']}, 'descriptionModule': {'briefSummary': 'The LMA Supreme is a new extraglottic airway device which brings together features of the LMA ProSeal, Fastrach and Unique. We test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed anesthetized patients', 'detailedDescription': 'The LMA Supreme is a new extraglottic airway device which brings together features of both the LMA ProSeal (high seal cuff, gastric access and bite block - to facilitate ventilation, airway protection and airway obstruction, respectively), the LMA Fastrach (fixed cuve tube and guiding handle - to facilitate insertion and fixation) and the LMA Unique (single use - prevention of disease transmission). The new features are that the airway tube incorporates a drain tube within its lumen to shorten and straighten its path, it is oval-shaped to match the shape of the mouth and to reduce rotation in the pharynx, the inner cuff has been strengthened to prevent airway obstruction from infolding and epiglottic fins have been added to prevent airway obstruction from epiglottic downfolding. In the following randomized, crossover study, we test the hypothesis that ease of insertion, oropharyngeal leak pressure, fiberoptic position and ease of gastric tube placement differ between the LMA ProSeal and the LMA Supreme in paralyzed, anesthetized patients'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiology physical status grade I-II\n* Age 18-80 yr\n* Elective gynecological surgery\n* Supine position\n\nExclusion Criteria:\n\n* Known or predicted difficult airway\n* Body mass index \\>35 kg m-2\n* Risk of aspiration'}, 'identificationModule': {'nctId': 'NCT00626951', 'acronym': 'Supreme', 'briefTitle': 'Crossover Study With the ProSeal and Supreme Laryngeal Mask Airway', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'The Supreme Laryngeal Mask Airway. A Randomized, Crossover Study With the ProSeal Laryngeal Mask Airway in Paralyzed, Anesthetized Patients', 'orgStudyIdInfo': {'id': '07208763-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'LMA Supreme', 'interventionNames': ['Device: LMA Supreme']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'LMA ProSeal', 'interventionNames': ['Device: LMA ProSeal']}], 'interventions': [{'name': 'LMA Supreme', 'type': 'DEVICE', 'description': 'Extraglottic airway devices', 'armGroupLabels': ['1']}, {'name': 'LMA ProSeal', 'type': 'DEVICE', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'overallOfficials': [{'name': 'Christian Keller, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University Innsbruck'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christian Keller MD MSc', 'oldOrganization': 'Medical University Innsbruck'}}}}