Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-03-03 @ 2:41 PM
Study NCT ID:
NCT01814306
Status:
UNKNOWN
Last Update Posted:
2013-03-19
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supreme LMA and Proseal LMA in Prone Anesthetized Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-03-15', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of insertion (quality of ventilation)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Ease of insertion, Complication and Glottic seal pressure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LMA Supreme,LMA Proseal,airway management,prone position'], 'conditions': ['Inadequate or Impaired Breathing Pattern or Ventilation']}, 'descriptionModule': {'briefSummary': 'There is no significant difference about success rate of two devices.', 'detailedDescription': 'There is no significant difference about success rate of two device: efficacy and safety'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society Anesthesiologists physical status I-III\n* Patient undergo elective orthopedics surgery in prone position under general anaesthesia\n\nExclusion Criteria:\n\n* Age \\<15year\n* Non-fast\n* Morbid obesity (BMI \\> 35kg/m2)\n* Pregnancy\n* Known or predicted difficult airway\n* GERD\n* History of laryngeal problem (injury,subglottic stenosis)\n* Local pharyngeal problem (abscess,tumor)\n* Poor dentation\n* Pulmonary disease'}, 'identificationModule': {'nctId': 'NCT01814306', 'acronym': 'SPLMA', 'briefTitle': 'Supreme LMA and Proseal LMA in Prone Anesthetized Patient', 'organization': {'class': 'OTHER', 'fullName': 'Prince of Songkla University'}, 'officialTitle': 'Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position', 'orgStudyIdInfo': {'id': 'SPLMA-100'}, 'secondaryIdInfos': [{'id': 'SPLMA-100-CPrechawai', 'type': 'REGISTRY', 'domain': 'CPrechawai'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supreme', 'description': 'Supreme LMA', 'interventionNames': ['Device: Supreme LMA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proseal', 'description': 'Proseal LMA', 'interventionNames': ['Device: Proseal LMA']}], 'interventions': [{'name': 'Supreme LMA', 'type': 'DEVICE', 'description': 'Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion', 'armGroupLabels': ['Supreme']}, {'name': 'Proseal LMA', 'type': 'DEVICE', 'description': 'Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion', 'armGroupLabels': ['Proseal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90110', 'city': 'Hat Yai', 'state': 'Changwat Songkhla', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Prince of Songkla University', 'geoPoint': {'lat': 7.00836, 'lon': 100.47668}}], 'overallOfficials': [{'name': 'Chatchai Prechawai', 'role': 'STUDY_CHAIR', 'affiliation': 'Prince of Songkla University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prince of Songkla University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiology Department', 'investigatorFullName': 'Chatchai Prechawai', 'investigatorAffiliation': 'Prince of Songkla University'}}}}