Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-30 @ 8:22 PM
Study NCT ID:
NCT03984032
Status:
COMPLETED
Last Update Posted:
2019-06-12
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-14', 'size': 237485, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-06-09T09:02', 'hasProtocol': False}, {'date': '2018-07-14', 'size': 384361, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-06-09T09:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-09', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-06-09', 'lastUpdatePostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure (OLP)', 'timeFrame': 'During induction of anaesthesia', 'description': 'To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme'}], 'secondaryOutcomes': [{'measure': 'Mean time to insertion', 'timeFrame': 'During induction of anaesthesia', 'description': 'To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme'}, {'measure': 'Gastric tube insertion', 'timeFrame': 'After induction of anaesthesia', 'description': 'To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme'}, {'measure': 'Laryngeal view', 'timeFrame': 'After induction of anaesthesia', 'description': 'To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme'}, {'measure': 'Complications', 'timeFrame': '24 hours', 'description': 'To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LMA Protector Cuff Pilot', 'LMA Supreme', 'Clinical Performance'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.\n\nExclusion Criteria:\n\n* BMI \\> 35\n* Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)\n* Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)'}, 'identificationModule': {'nctId': 'NCT03984032', 'briefTitle': 'LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Kebangsaan Malaysia Medical Centre'}, 'officialTitle': 'Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients', 'orgStudyIdInfo': {'id': 'UKM PPI/111/8/JEP-2018-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMA Protector Cuff Pilot', 'interventionNames': ['Device: LMA Supreme']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMA Supreme', 'interventionNames': ['Device: LMA Protector Cuff Pilot']}], 'interventions': [{'name': 'LMA Protector Cuff Pilot', 'type': 'DEVICE', 'description': 'Assessing the clinical performance of LMA Protector Cuff Pilot', 'armGroupLabels': ['LMA Supreme']}, {'name': 'LMA Supreme', 'type': 'DEVICE', 'description': 'Assessing the clinical performance of LMA Supreme', 'armGroupLabels': ['LMA Protector Cuff Pilot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Universiti Kebangsaan Malaysia Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liu Chian Yong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant Anaesthesiologist', 'investigatorFullName': 'Liu Chian Yong', 'investigatorAffiliation': 'Universiti Kebangsaan Malaysia Medical Centre'}}}}