Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03251105
Status:
COMPLETED
Last Update Posted:
2017-08-16
First Post:
2017-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supreme Versus Proseal Laryngeal Mask Airways in Infants
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': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Infants, who were scheduled to undergo lower abdominal surgery and to receive anaesthesia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2017-08-07', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'performance characteristics', 'timeFrame': 'operation duration', 'description': 'insertion time in minutes'}], 'secondaryOutcomes': [{'measure': 'haemodynamics', 'timeFrame': 'operation duration', 'description': 'end tidal CO2 (EtCO2) in mmHg'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery', 'Infant Conditions', 'Anesthesia']}, 'referencesModule': {'references': [{'pmid': '25074619', 'type': 'BACKGROUND', 'citation': 'Luce V, Harkouk H, Brasher C, Michelet D, Hilly J, Maesani M, Diallo T, Mangalsuren N, Nivoche Y, Dahmani S. Supraglottic airway devices vs tracheal intubation in children: a quantitative meta-analysis of respiratory complications. Paediatr Anaesth. 2014 Oct;24(10):1088-98. doi: 10.1111/pan.12495. Epub 2014 Jul 30.'}, {'pmid': '28870163', 'type': 'DERIVED', 'citation': 'Oba S, Turk HS, Isil CT, Erdogan H, Sayin P, Dokucu AI. Comparison of the Supreme and ProSeal laryngeal mask airways in infants: a prospective randomised clinical study. BMC Anesthesiol. 2017 Sep 5;17(1):125. doi: 10.1186/s12871-017-0418-z.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.', 'detailedDescription': 'Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants.\n\nIn this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.\n\nInfants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted.\n\nDemographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for elective, minor (\\<1 hour duration), lower abdominal surgery, including unilateral herniorrhaphy and unilateral orchidopexy\n\nExclusion Criteria:\n\n* premature birth, potentially difficult airway, clinically significant upper respiratory tract infection and risk of aspiration, such as gastro-oesophageal reflux disease'}, 'identificationModule': {'nctId': 'NCT03251105', 'briefTitle': 'Supreme Versus Proseal Laryngeal Mask Airways in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Sisli Hamidiye Etfal Training and Research Hospital'}, 'officialTitle': 'Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study', 'orgStudyIdInfo': {'id': 'SEEAH/26.04.2016/659'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ProSeal group', 'description': 'This group received the ProSeal LMA for supraglottic airway intubation and ventilation during anaesthesia.', 'interventionNames': ['Device: supraglottic airway intubation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supreme group', 'description': 'This group received the Supreme LMA for supraglottic airway intubation and ventilation during anaesthesia.', 'interventionNames': ['Device: supraglottic airway intubation']}], 'interventions': [{'name': 'supraglottic airway intubation', 'type': 'DEVICE', 'armGroupLabels': ['ProSeal group', 'Supreme group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sibel Oba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We can only share data as Exel or SSPS, but not with patient names.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sisli Hamidiye Etfal Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist, M.D.', 'investigatorFullName': 'Canan Tulay ISIL', 'investigatorAffiliation': 'Sisli Hamidiye Etfal Training and Research Hospital'}}}}