Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-31 @ 8:22 AM
Study NCT ID:
NCT02531256
Status:
COMPLETED
Last Update Posted:
2016-03-01
First Post:
2015-08-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigation of a New Laryngeal Mask Airway LMA Protector
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-28', 'studyFirstSubmitDate': '2015-08-21', 'studyFirstSubmitQcDate': '2015-08-21', 'lastUpdatePostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of insertion attempts', 'timeFrame': '5 minutes', 'description': 'Time of pickup of device to the presence of carbon dioxide trace on'}], 'secondaryOutcomes': [{'measure': 'Oropharyngeal Leak Pressure', 'timeFrame': '5 minutes', 'description': 'Closure of expiratory valve of circle anaesthetic breathing system and noting the airway pressure in the breathing system at equilibration with cuff pressure of 60cmH2O or up to maximum of 40cmH2O'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Laryngeal Mask Airway'], 'conditions': ['Airway Morbidity']}, 'referencesModule': {'references': [{'pmid': '28219323', 'type': 'DERIVED', 'citation': 'Sng BL, Ithnin FB, Mathur D, Lew E, Han NR, Sia AT. A preliminary assessment of the LMA protector in non-paralysed patients. BMC Anesthesiol. 2017 Feb 20;17(1):26. doi: 10.1186/s12871-017-0323-5.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of LMA Protector', 'detailedDescription': 'This new disposable silicone airway device provides access and functional separation of the respiratory and digestive tracts. The airway tube is elliptical in cross section ending at the laryngeal opening. The device contains 2 drainage channels (male and female port) proximally that continues into a common distal opening posterior to the distal airway cuff bowl. The female port allows a gastric tube to be passed into the stomach, whilst a suction tube may be attached to the male suction port offering removal of gastric fluid around the upper oesophagus sphincter.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* planned elective surgery with indication for LMA use\n\nExclusion Criteria:\n\n* body mass index of 30 or more, known gastro-oesophageal reflux, patients with increased risk of aspiration, upper airway pathology and mouth opening of less than 2 cm'}, 'identificationModule': {'nctId': 'NCT02531256', 'acronym': 'LMA', 'briefTitle': 'An Investigation of a New Laryngeal Mask Airway LMA Protector', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'An Investigation of a New Laryngeal Mask Airway LMA Protector', 'orgStudyIdInfo': {'id': '2013/709/D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMA Protector', 'description': 'Single Use Supraglottic Airway Device with 2 ports for gastric access (male and female port)', 'interventionNames': ['Device: LMA Protector']}], 'interventions': [{'name': 'LMA Protector', 'type': 'DEVICE', 'description': 'Insertion of airway device for airway management during gynaecological procedure', 'armGroupLabels': ['LMA Protector']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ban L Sng, FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}