Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT01003327
Status:
COMPLETED
Last Update Posted:
2010-07-23
First Post:
2009-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-22', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'leak pressure of the laryngeal masks', 'timeFrame': 'directly after insertion of the laryngeal mask'}], 'secondaryOutcomes': [{'measure': 'Insertion time and ease of insertion of the laryngeal mask', 'timeFrame': 'during insertion of the laryngeal mask'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laryngeal mask, leak pressure', 'leak pressure'], 'conditions': ['Surgery', 'Intubation']}, 'descriptionModule': {'briefSummary': 'The intention of this study is to compare the performance of the single-use I-gel laryngeal mask with the classic laryngeal mask in 50 patients with a BMI\\>25 during elective surgery. Primary outcome is the leak pressure. Secondary outcomes include ease and duration of insertion.', 'detailedDescription': 'Inclusion criteria of this randomized cross-over study are: BMI \\> 25, elective surgery in supine position, age\\>18 years, ASA I-II; Exclusion criteria are: difficult airway, pregnancy, history of reflux or gastrointestinal disorders, abdominal or thoracic surgery; In this cross-over trial both airway devices are inserted in the same patient, the order of insertion is randomized. Patient receive monitoring with blood pressure, ECG and pulse oxymetry during operation. Anaesthesia is induced intravenously using fentanyl (0.001 mg/kg) and propofol (3-5 mg/kg). The I-gel laryngeal mask is inserted with a gastric tube. The classic laryngeal mask was cuffed after insertion with a cuff pressure of 60 cmH2O. The first device is removed 5 minutes after insertion and replaced by the second device. Ease of insertion is graded as very easy=1, easy=2, difficult=3 and very difficult=4. Leak pressure is measured by two tests: In the first test the spill valve is closed at a fresh gas flow of 6l/min and the minimum airway pressure at which gas leaked around the airway device is recorded by listening for an audible leak. In the second test leakage is measured during pressure controlled ventilation. Therefore we administer a fresh gas flow of 3l/min, FiO2 of 50%, inspiration to expiration ratio of 1:2 and a frequency of breathing of 12. Leakage can be measured by the respirator. We record inspiration pressure, mean pressure, plateau pressure, tidal volume and peep at which the first measurable leakage occurred.\n\nFor statistical analysis we will use t-tests with a power of 80% and a p \\< 0.05.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 25, elective surgery in supine position,\n* age \\> 18 years,\n* ASA I-II;\n\nExclusion Criteria:\n\n* difficult airway, pregnancy,\n* history of reflux or gastrointestinal disorders,\n* abdominal or thoracic surgery;'}, 'identificationModule': {'nctId': 'NCT01003327', 'briefTitle': 'Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 During Elective Surgery', 'orgStudyIdInfo': {'id': '354/2009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'I-gel inserted first', 'description': 'The I-gel airway is insewrted first, then the LMA-Unique', 'interventionNames': ['Device: I-gel']}, {'type': 'OTHER', 'label': 'LMA-Unique inserted first', 'description': 'LMA-Unique airway is inserted first, then the I-gel', 'interventionNames': ['Device: LMA-Unique']}], 'interventions': [{'name': 'I-gel', 'type': 'DEVICE', 'description': 'intubation with I-gel airway', 'armGroupLabels': ['I-gel inserted first']}, {'name': 'LMA-Unique', 'type': 'DEVICE', 'description': 'LMA-Unique airway is inserted first, then the I-gel', 'armGroupLabels': ['LMA-Unique inserted first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical university of vienna, General hospital of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Ulrike Weber, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ulrike Weber', 'oldOrganization': 'Medical University of Vienna'}}}}