Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-29 @ 9:08 AM
Study NCT ID:
NCT01385761
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2011-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway 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': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-09', 'studyFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2011-06-29', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oropharyngeal leak pressure', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supraglottic airway devices'], 'conditions': ['Children']}, 'referencesModule': {'references': [{'pmid': '21518103', 'type': 'BACKGROUND', 'citation': 'Jagannathan N, Sohn LE, Mankoo R, Langen KE, Roth AG, Hall SC. Prospective evaluation of the self-pressurized air-Q intubating laryngeal airway in children. Paediatr Anaesth. 2011 Jun;21(6):673-80. doi: 10.1111/j.1460-9592.2011.03576.x.'}, {'pmid': '15298876', 'type': 'BACKGROUND', 'citation': 'Shimbori H, Ono K, Miwa T, Morimura N, Noguchi M, Hiroki K. Comparison of the LMA-ProSeal and LMA-Classic in children. Br J Anaesth. 2004 Oct;93(4):528-31. doi: 10.1093/bja/aeh238. Epub 2004 Aug 6.'}, {'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 purpose of this study is to compare the clinical efficacy of the air-Q ILA-SP with the current standard of care, the LMA Unique in anesthetized non-paralyzed pediatric patients.', 'detailedDescription': 'The goal for this randomized, non-crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA-SP in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. We hypothesize that airway leak pressures with the ILA-SP will be superior to the LMA upon initial device placement, and ten minutes after device placement. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. Ease of placement, fiberoptic grade of laryngeal view, and complications (airway related, gastric insufflation, trauma) will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children weighing 20 to 30 kg undergoing surgery requiring a supraglottic airway device', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing general anesthesia using a supraglottic airway device\n* 3 to 9 years of age\n* 20 to 30 kilograms in weight\n\nExclusion Criteria:\n\n* History of a difficult airway\n* Active gastrointestinal reflux\n* Active upper respiratory tract infection'}, 'identificationModule': {'nctId': 'NCT01385761', 'briefTitle': 'LMA Unique TM & the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'A Prospective, Randomized Non- Crossover Investigation of the LMA Unique TM and the Self Pressurized Air-Q TM Intubating Laryngeal Airway in Children', 'orgStudyIdInfo': {'id': 'IRB#2011-14642'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Laryngeal Mask airway (LMA)', 'description': 'children weighing 20 to 30 kg', 'interventionNames': ['Device: Laryngeal Mask Airway']}, {'label': 'Intubating Laryngeal Airway (ILA-SP)', 'description': 'Children weighing 20-30 kg', 'interventionNames': ['Device: air-QTM Intubating Laryngeal Airway']}], 'interventions': [{'name': 'Laryngeal Mask Airway', 'type': 'DEVICE', 'otherNames': ['Laryngeal Mask AirwayTM (Laryngeal Mask Airway North America; San Diego, CA USA)'], 'description': 'Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.', 'armGroupLabels': ['Laryngeal Mask airway (LMA)']}, {'name': 'air-QTM Intubating Laryngeal Airway', 'type': 'DEVICE', 'otherNames': ['air-QTM Intubating Laryngeal Airway Mercury Medical;Clearwater, Fl USA'], 'description': 'Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.', 'armGroupLabels': ['Intubating Laryngeal Airway (ILA-SP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60618', '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': 'primary investigator', 'investigatorFullName': 'Narasimhan Jagannathan', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}