Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01425151
Status:
COMPLETED
Last Update Posted:
2011-09-22
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-20', 'studyFirstSubmitDate': '2011-08-26', 'studyFirstSubmitQcDate': '2011-08-26', 'lastUpdatePostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure', 'timeFrame': '10 Minutes'}], 'secondaryOutcomes': [{'measure': 'Insertion success rate', 'timeFrame': '1 Minute'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Device Success Rate', 'Device Performance']}, 'descriptionModule': {'briefSummary': 'In the following randomized, crossover study, the investigators test the hypothesis that ease of insertion and oropharyngeal leak pressure differ between the LMA ProSealTM and the i-GelTM in anesthetized pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '18 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I and II\n* Age 1.5-6 years\n\nExclusion Criteria:\n\n* known or predicted difficult airway\n* body mass index \\> 35 kg m-2\n* risk of aspiration'}, 'identificationModule': {'nctId': 'NCT01425151', 'briefTitle': 'The i-GelTM. A Randomized, Crossover Study With the Laryngeal Mask Airway ProSealTM in Anesthetized Pediatric Patients', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'orgStudyIdInfo': {'id': 'Schulthess_Anä_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'i-Gel', 'interventionNames': ['Device: i-Gel']}, {'type': 'EXPERIMENTAL', 'label': 'ProSeal', 'interventionNames': ['Device: ProSeal']}], 'interventions': [{'name': 'i-Gel', 'type': 'DEVICE', 'description': 'Oropharyngeal leak pressure Insertion success', 'armGroupLabels': ['i-Gel']}, {'name': 'ProSeal', 'type': 'DEVICE', 'description': 'Oropharyngeal leak pressure Insertion success', 'armGroupLabels': ['ProSeal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Klinik für Anästhesie und Allgemeine Intensivmedizin', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Christian Keller', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Christian Keller, MD, M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Schulthess Klinik'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, M.Sc.', 'investigatorFullName': 'ChristianKeller', 'investigatorAffiliation': 'Schulthess Klinik'}}}}