Ignite Creation Date:
2025-12-24 @ 2:10 PM
Ignite Modification Date:
2025-12-29 @ 3:43 PM
Study NCT ID:
NCT01653795
Status:
COMPLETED
Last Update Posted:
2012-11-20
First Post:
2012-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of the Laryngeal Mask Airway (LMA) - Unique and LMA-Supreme in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-03-18', 'releaseDate': '2014-02-03'}], 'estimatedResultsFirstSubmitDate': '2014-02-03'}}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-17', 'studyFirstSubmitDate': '2012-07-27', 'studyFirstSubmitQcDate': '2012-07-30', 'lastUpdatePostDateStruct': {'date': '2012-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', '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.'}], '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 (only in patients who receive LMA Supreme)', '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. The LMA Unique does not contain a gastric port so this outcome will only be assessed in patients who received the LMA Supreme device.'}, {'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': 'Incidence of device repositioning and/or replacement', 'timeFrame': 'Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours', 'description': 'Intra-operative device repositioning or replacement of the device due to excessive air leak or airway obstruction, as evidenced by an obstructive pattern on the continuous end-tidal carbon dioxide monitor that leads to a decrease in oxygen saturation by pulse oximetry to less than 90%.'}, {'measure': 'Oropharyngolaryngeal morbidity at discharge', 'timeFrame': 'Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours', 'description': "Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort."}, {'measure': 'Oropharyngolaryngeal morbidity at 24 hours post-operatively', 'timeFrame': 'Measured at 24 hours after device placement/study initiation', 'description': "Assessed by the subject's response or parents subjective assessment to standardized questions regarding oropharyngeal complaints such as sore throat, jaw pain, neck discomfort."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Laryngeal Mask Airway in Children']}, 'referencesModule': {'references': [{'pmid': '22420717', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Langen KE, Anderson K. A randomised comparison of the LMA SupremeTM and LMAProSealTM in children. Anaesthesia. 2012 Jun;67(6):632-9. doi: 10.1111/j.1365-2044.2012.07088.x. Epub 2012 Mar 15.'}, {'pmid': '22416790', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Chang E, Sawardekar A. A cohort evaluation of the laryngeal mask airway-Supreme in children. Paediatr Anaesth. 2012 Aug;22(8):759-64. doi: 10.1111/j.1460-9592.2012.03832.x. Epub 2012 Mar 15.'}, {'pmid': '22070630', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Sawardekar A, Chang E, Langen KE, Anderson K. A randomised trial comparing the laryngeal mask airway Supreme with the laryngeal mask airway Unique in children. Anaesthesia. 2012 Feb;67(2):139-44. doi: 10.1111/j.1365-2044.2011.06960.x. Epub 2011 Nov 9.'}, {'pmid': '22352745', 'type': 'BACKGROUND', 'citation': 'Lee JR, Kim MS, Kim JT, Byon HJ, Park YH, Kim HS, Kim CS. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children. Anaesthesia. 2012 Jun;67(6):606-11. doi: 10.1111/j.1365-2044.2012.07072.x. Epub 2012 Feb 21.'}, {'pmid': '22151106', 'type': 'BACKGROUND', 'citation': 'Goyal R, Shukla RN, Kumar G. Comparison of size 2 i-gel supraglottic airway with LMA-ProSeal and LMA-Classic in spontaneously breathing children undergoing elective surgery. Paediatr Anaesth. 2012 Apr;22(4):355-9. doi: 10.1111/j.1460-9592.2011.03757.x. Epub 2011 Dec 8.'}, {'pmid': '21883132', 'type': 'BACKGROUND', 'citation': 'Beringer RM, Kelly F, Cook TM, Nolan J, Hardy R, Simpson T, White MC. A cohort evaluation of the paediatric i-gel() airway during anaesthesia in 120 children. Anaesthesia. 2011 Dec;66(12):1121-6. doi: 10.1111/j.1365-2044.2011.06884.x. Epub 2011 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized prospective study is to compare two single-use laryngeal mask airways the LMA Unique and the LMA Supreme, in pediatric patients. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior to the LMA Unique.', 'detailedDescription': 'The goal of this study is to compare the LMA Unique and LMA-Supreme in children undergoing anesthesia. The investigators hypothesize that airway leak pressures with the LMA Supreme will be superior when compared with the LMA Unique at two different standardized intracuff pressures (40 and 60 cm H20). Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use, and complications will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing general anesthesia using a supraglottic airway device\n\nExclusion Criteria:\n\n* ASA class IV, V, Emergency procedures\n* active respiratory infection\n* known history of difficult mask ventilation\n* a diagnosis of a congenital syndrome associated with difficult airway management\n* airway abnormalities (e.g., laryngomalacia, subglottic stenosis)\n* active gastrointestinal reflux\n* coagulopathy\n* clinically significant pulmonary disease(s)'}, 'identificationModule': {'nctId': 'NCT01653795', 'briefTitle': 'A Comparison of the Laryngeal Mask Airway (LMA) - Unique 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-Unique and Laryngeal Mask Airway-Supreme in Children', 'orgStudyIdInfo': {'id': 'LMA-U vs SLMA (multiple sizes)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LMA Unique', 'interventionNames': ['Device: LMA Unique: control device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LMA Supreme', 'interventionNames': ['Device: LMA Supreme: comparison device']}], 'interventions': [{'name': 'LMA Unique: control device', 'type': 'DEVICE', 'otherNames': ['Laryngeal Mask Airway'], 'description': "LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.", 'armGroupLabels': ['LMA Unique']}, {'name': 'LMA Supreme: comparison device', 'type': 'DEVICE', 'otherNames': ['Laryngeal Mask Airway'], 'description': "LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.", 'armGroupLabels': ['LMA Supreme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Narasimhan Jagannathan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, '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"}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-02-03', 'type': 'RELEASE'}, {'date': '2014-03-18', 'type': 'RESET'}], 'unpostedResponsibleParty': "Narasimhan Jagannathan, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago"}}}}