Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT02252120
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2014-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laryngeal Mask Airway Supreme Versus Laryngeal Tube
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ease of insertion', 'timeFrame': '1 Min', 'description': 'We allowed one attempt before considering a failure, defining failed insertion by any of the following criteria:\n\n1\\) failed passage into the pharynx; 2) malposition (air leaks); and 3) ineffective ventilation (maximum expired tidal volume \\<4 ml kg-1 or end-tidal CO2 \\> 50 mm Hg (if correctly positioned). ). Insertion time was defined as the interval between picking up the prepared device and successfully placement. After placement effective ventilation was tested by observation of chest wall movement and capnometric curve trace. If insertion failed the etiology was signed on the CRF. After a first insertion attempt one single attempt with the guiding technique was allowed.'}], 'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure', 'timeFrame': '5 Min', 'description': 'Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia 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': 'Fiberoptic position', 'timeFrame': '5 Min', 'description': 'The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adverse Anesthesia Outcome']}, 'descriptionModule': {'briefSummary': 'The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LMA SupremeTM and the Laryngeal Tube LTS IITM in non-paralyzed anaesthetized pediatric patients', 'detailedDescription': 'The Laryngeal Tube LTS IITM (VBM-Medizintechnik GmbH, Sulz a.N, Germany) is a well established reusable latex free, extraglottic airway device. A proximal (pharyngeal) and a distal (esophageal) cuff are inflated with a single cuff pilot line. In between lies the ventilation orifice. The LMA SupremeTM (Teleflex San Diego, CA, USA) is a single use well studied laryngeal mask airway. Both devices have a drain tube to allow access to the gastrointestinal tract. Actually there are no studies comparing Laryngeal Tube LTS IITM and LMA SupremeTM use in small children. Therefore the aim of this study was to evaluate the clinical performance of the Laryngeal Tube LTS IITM compared to the LMA SupremeTM. The investigators hypothesized that design differences should lead to differences in efficacy of seal and anatomic position. In this randomized, crossover study, the investigators test the hypothesis that in non-paralyzed pediatric patients the oropharyngeal leak pressure and fiberoptic position differs between the size 2 Laryngeal Tube LTS IITM and the LMA SupremeTM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II\n* age 1.5 - 9 years\n* minor surgery\n* extraglottic airway device\n\nExclusion Criteria:\n\n* age (\\<18 months, \\>9 years)\n* weight (\\<10 kg, \\>25 kg)\n* a known difficult airway\n* risk of aspiration'}, 'identificationModule': {'nctId': 'NCT02252120', 'briefTitle': 'Laryngeal Mask Airway Supreme Versus Laryngeal Tube', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Laryngeal Mask Airway Supreme Versus Laryngeal Tube in Non-paralysed, Anesthetized Children. A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position Using the Size 2', 'orgStudyIdInfo': {'id': 'Schulthess_Anä_4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supreme', 'description': 'Supreme LMA', 'interventionNames': ['Device: Supreme', 'Device: Laryngeal Tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal Tube', 'description': 'Laryngeal tube LTSII', 'interventionNames': ['Device: Supreme', 'Device: Laryngeal Tube']}], 'interventions': [{'name': 'Supreme', 'type': 'DEVICE', 'armGroupLabels': ['Laryngeal Tube', 'Supreme']}, {'name': 'Laryngeal Tube', 'type': 'DEVICE', 'armGroupLabels': ['Laryngeal Tube', 'Supreme']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christian Keller, MD, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik, Lengghalde 2, 8008 Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Salzburg', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. M.Sc.', 'investigatorFullName': 'ChristianKeller', 'investigatorAffiliation': 'Schulthess Klinik'}}}}