Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT01449656
Status:
COMPLETED
Last Update Posted:
2011-12-12
First Post:
2011-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017214', 'term': 'Laryngeal Masks'}], 'ancestors': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007440', 'term': 'Intubation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D008397', 'term': 'Masks'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-09', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-06', 'lastUpdatePostDateStruct': {'date': '2011-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway Leak Pressure', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed completely.'}], 'secondaryOutcomes': [{'measure': 'Time to secure the airway', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'From picking up the airway device to bilateral chest expansion and presence of ETCO2'}, {'measure': 'Number of attempts to place the device', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'number of attempts needed for successful placement will be recorded (maximum of 3 attempts will be considered as a failure)'}, {'measure': 'Fiberoptic grade of laryngeal view', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'The laryngeal alignment through the devices will be graded using an established scoring system'}, {'measure': 'Gastric insufflation', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'The presence of gastric insufflations will be assessed during leak pressure testing by using epigastric auscultation'}, {'measure': 'Ease of gastric tube placement', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'The ease of gastric placement will be timed and assessed using a subjective scale'}, {'measure': 'Fiberoptic view through the gastric tube', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'The view through the gastric drain tube of the LMA supreme will be assessed and graded using an established scoring system'}, {'measure': 'feasibility of positive pressure ventilation', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'Peak inspiratory pressure and tidal volumes will be recorded. Maximum peak inspiratory pressure will be the airway leak pressure was determined for each patient'}, {'measure': 'Quality of the airway', 'timeFrame': 'participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours', 'description': 'The quality of hands free anesthesia will be assessed during maintenance of anesthesia using a previously described scale'}, {'measure': 'Adverse effects', 'timeFrame': 'Participants will be followed for the duration of anesthesia and 24 hours postoperatively', 'description': 'complications such as oxygen desaturations, mucosal trauma, reflex activation of the airway, sore throat, dysphonia will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Children']}, 'referencesModule': {'references': [{'pmid': '21839703', 'type': 'BACKGROUND', 'citation': 'Trevisanuto D, Parotto M, Doglioni N, Ori C, Zanardo V, Micaglio M. The Supreme Laryngeal Mask Airway (LMA): a new neonatal supraglottic device: comparison with Classic and ProSeal LMA in a manikin. Resuscitation. 2012 Jan;83(1):97-100. doi: 10.1016/j.resuscitation.2011.07.032. Epub 2011 Aug 11.'}, {'pmid': '20540172', 'type': 'BACKGROUND', 'citation': 'Seet E, Rajeev S, Firoz T, Yousaf F, Wong J, Wong DT, Chung F. Safety and efficacy of laryngeal mask airway Supreme versus laryngeal mask airway ProSeal: a randomized controlled trial. Eur J Anaesthesiol. 2010 Jul;27(7):602-7. doi: 10.1097/eja.0b013e32833679e3.'}, {'pmid': '19572845', 'type': 'BACKGROUND', 'citation': 'White MC, Cook TM, Stoddart PA. A critique of elective pediatric supraglottic airway devices. Paediatr Anaesth. 2009 Jul;19 Suppl 1:55-65. doi: 10.1111/j.1460-9592.2009.02997.x.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.', 'detailedDescription': 'The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children weighing 10 to 20 kg undergoing surgical or medical procedures under anesthesia requiring a supraglottic airway device', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing general anesthesia using a supraglottic airway device\n* weight 10-20 kg\n* age 6 months-6 years\n\nExclusion Criteria:\n\n* ASA class IV, V Emergency procedures\n* History of a difficult airway\n* Active gastrointestinal reflux\n* Active upper respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT01449656', 'briefTitle': 'A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the Laryngeal Mask Airway-ProsealTM in Children', 'orgStudyIdInfo': {'id': 'PLMA vs SLMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LMA proseal', 'interventionNames': ['Device: LMA Proseal: control device']}, {'label': 'LMA Supreme', 'interventionNames': ['Device: LMA Supreme: comparison device']}], 'interventions': [{'name': 'LMA Proseal: control device', 'type': 'DEVICE', 'otherNames': ['laryngeal mask airway'], 'description': 'LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization', 'armGroupLabels': ['LMA proseal']}, {'name': 'LMA Supreme: comparison device', 'type': 'DEVICE', 'otherNames': ['laryngeal mask airway'], 'description': 'LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization', 'armGroupLabels': ['LMA Supreme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Childrens Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Narasimhan Jagannathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Childrens Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Narasimhan Jagannathan', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}