Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:49 PM
Study NCT ID:
NCT01141660
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2010-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007442', 'term': 'Intubation, Intratracheal'}, {'id': 'D017214', 'term': 'Laryngeal Masks'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'baldassc@yahoo.com', 'phone': '7576689853', 'title': 'Cristina Baldassari', 'organization': 'Eastern Virginia Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'No adverse events collected', 'description': 'No adverse events collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Laryngospasm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}, {'id': 'OG001', 'title': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postanesthesia Recovery Times', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}, {'id': 'OG001', 'title': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}], 'classes': [{'categories': [{'measurements': [{'value': '95.59', 'spread': '77.72', 'groupId': 'OG000'}, {'value': '83.50', 'spread': '58.91', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'After surgery', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}, {'id': 'FG001', 'title': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}, {'id': 'BG001', 'title': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '5.69', 'spread': '2.3', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 131}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2010-06-07', 'resultsFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-06-08', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-13', 'studyFirstPostDateStruct': {'date': '2010-06-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Laryngospasm', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Postanesthesia Recovery Times', 'timeFrame': 'After surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Laryngeal Mask Airway', 'Tonsillectomy']}, 'referencesModule': {'references': [{'pmid': '8240471', 'type': 'BACKGROUND', 'citation': 'Williams PJ, Bailey PM. Comparison of the reinforced laryngeal mask airway and tracheal intubation for adenotonsillectomy. Br J Anaesth. 1993 Jan;70(1):30-3. doi: 10.1093/bja/70.1.30.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to compare the use of laryngeal mask airway (LMA) and endotracheal tube (ETT) in pediatric adenotonsillectomy. The primary objective is to assess the incidence of post-operative laryngospasm between the LMA and ETT. The investigators also sought to compare anesthetic, operative, and recovery times in the LMA and ETT groups. We hypothesized that the LMA would be a safe efficient alternative to the ETT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 2 to 12 years of age undergoing elective adenotonsillectomy for obstructive sleep apnea or chronic tonsillitis were included in the study.\n\nExclusion Criteria:\n\n* Exclusion criteria were as follows: Body Mass Index (BMI) greater than 35 and craniofacial anomalies.'}, 'identificationModule': {'nctId': 'NCT01141660', 'briefTitle': 'Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Use of Laryngeal Mask Airway in Pediatric Adenotonsillectomy', 'orgStudyIdInfo': {'id': 'HM10692'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endotracheal Tube', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.', 'interventionNames': ['Device: Endotracheal Tube']}, {'type': 'EXPERIMENTAL', 'label': 'Laryngeal Mask Airway', 'description': 'Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.', 'interventionNames': ['Device: Laryngeal mask airway']}], 'interventions': [{'name': 'Endotracheal Tube', 'type': 'DEVICE', 'otherNames': ['ETT', 'Endotracheal intubation'], 'description': 'Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.', 'armGroupLabels': ['Endotracheal Tube']}, {'name': 'Laryngeal mask airway', 'type': 'DEVICE', 'otherNames': ['LMA'], 'description': 'Randomized to either Laryngeal mask airway or endotracheal tube', 'armGroupLabels': ['Laryngeal Mask Airway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virigina Commonwealth University Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Kelley Dodson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}