Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-03-01 @ 8:54 PM
Study NCT ID:
NCT01749033
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2012-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A New Insertion Technique for Laryngeal Mask Airway
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'l-hu2@northwestern.edu', 'phone': '312-695-3428', 'title': 'Ling Hu M.D.', 'organization': 'Northwerstern University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'We did not limit the intracuff pressure of the device, but rather used the manufactures recommended volume in the cuff. . There are no current standard of care guidelines for the ideal intracuff pressures within the oropharngolaryngeal mask airway.'}}, 'adverseEventsModule': {'timeFrame': '24 hours after the airway device removal', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.', 'otherNumAtRisk': 147, 'otherNumAffected': 83, 'seriousNumAtRisk': 147, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.', 'otherNumAtRisk': 145, 'otherNumAffected': 80, 'seriousNumAtRisk': 145, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 ELLIA Technique', 'description': 'Group 3 (ELLIA): Using the ELLIA technique.\n\nGroup 3 ELLIA: Group 3 (ELLIA): Using the ELLIA technique', 'otherNumAtRisk': 149, 'otherNumAffected': 78, 'seriousNumAtRisk': 149, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.', 'notes': 'Postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia during the timeframe from removal of the airway to 24 hours after the airway removal.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 83, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 80, 'numAffected': 80}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 78, 'numAffected': 78}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Airway complications'}, {'term': 'Blood on OMA after removal of the OMA', 'notes': 'The presence of blood on the OMA after removal from the airway/', 'stats': [{'groupId': 'EG000', 'numAtRisk': 147, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 145, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 149, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Airway complications'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Present With Postoperative Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'classes': [{'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Outcomes for This Study Will be Postoperative Dysphagia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.76', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Severity of Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '440'}, {'value': '143', 'groupId': 'OG001', 'lowerLimit': '24', 'upperLimit': '440'}, {'value': '102', 'groupId': 'OG002', 'lowerLimit': '34', 'upperLimit': '275'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour.\n\nLow pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood on LMA After Removal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '149', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'OG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'OG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC Group 3 (ELL-PIC): Using the ELL-PICtechnique'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '.02', 'estimateComment': 'The reported p value was calculated.', 'groupDescription': 'We planned a sample size of 429 to achieve a 80% power to detect an effect size difference of w=0.15 using 2 degrees of freedom chi-square test with a significance level (alpha) of .05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately after LMA removal', 'description': 'Presence of blood immediately after the removal of the LMA after surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'FG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'FG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not receive allocated intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}, {'value': '450', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 Classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.\n\nGroup 1 Classic: Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.'}, {'id': 'BG001', 'title': 'Group 2 Pre Inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer\n\nGroup 2 pre-inflated: Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA from the manufacturer.'}, {'id': 'BG002', 'title': 'Group 3 ELL-PIC Technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.\n\nGroup 3 ELL-PIC: Group 3 (ELL-PIC): Using the ELL-PIC technique'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45', 'spread': '16', 'groupId': 'BG000'}, {'value': '47', 'spread': '16', 'groupId': 'BG001'}, {'value': '46', 'spread': '16', 'groupId': 'BG002'}, {'value': '46', 'spread': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participants age in years.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '185', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subject number is different because of dropout, lost to follow up or changed anesthetic care.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '450', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.'}, {'title': 'OMA Insertion attempts', 'classes': [{'title': '1 attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '384', 'groupId': 'BG003'}]}]}, {'title': '2 attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': '3 attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': '4 attempts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The number of total attempts needed to place the airway device.', 'unitOfMeasure': 'Participants', 'populationDescription': 'The (N) analyzed is lower because of drop outs and change in anesthesic method during the case.'}, {'title': 'OSA insertion time in seconds', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '67'}, {'value': '54', 'groupId': 'BG001', 'lowerLimit': '44', 'upperLimit': '65'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '65'}, {'value': '55', 'groupId': 'BG003', 'lowerLimit': '45', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'description': 'Time in seconds required by the operator to place the airway device.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Subjects were lost to follow up or the anesthetic care changed during the surgical procedure.'}, {'title': 'Duration of OMA device', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '100'}, {'value': '65', 'groupId': 'BG001', 'lowerLimit': '54', 'upperLimit': '105'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '51', 'upperLimit': '105'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '105'}]}]}], 'paramType': 'MEDIAN', 'description': 'The duration of time in minutes the OMA device was in the larynx.', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Subjects were lost to follow up or anesthetic management technique changed.'}, {'title': 'BMI (kg/m∧2 )', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '27.4', 'spread': '5.2', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '27.8', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '27.7', 'spread': '5.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'description': 'BMI (Body Mass Index) (kg/m∧ 2) of participants.', 'unitOfMeasure': 'BMI (kg/m∧2 )', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Subjects lost to follow up or required a different anesthetic regimen during the surgical procedure.'}, {'title': 'Neck Circumference (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '41'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '41'}, {'value': '38', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '41'}, {'value': '38', 'groupId': 'BG003', 'lowerLimit': '34', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'description': 'Neck circumference in centimeters of participants.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Some subjects may be have been lost to followup or there was a change in anesthetic care during the surgical procedure.'}, {'title': 'Mallampati Class', 'classes': [{'title': 'Class I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}]}]}, {'title': 'Class II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': 'Class III', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'Class IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Mallampati score or classification is used to predict the ease of endotracheal intubation. Rated on a score of 1 good to 4 poor.', 'unitOfMeasure': 'participants', 'populationDescription': 'Some participants may have been lost to follow up, dropped out or there was a change in anesthetic technique during the surgical procedure'}, {'title': 'ASA physical status', 'classes': [{'title': 'ASA l', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '214', 'groupId': 'BG003'}]}]}, {'title': 'ASA ll', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}]}, {'title': 'ASA lll', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Not documented', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The ASA physical status classification system is a system for assessing the fitness of a patient prior to a surgical procedure. They include: 1-healthy person.,2-mild systemic disease,3-severe systemic disease,4-severe systemic disease that is a constant threat to life,5- a moribund person who is not expected to survive without the operation and 6- a declared brain-dead person whose organs are being removed for donor purposes.', 'unitOfMeasure': 'ASA STATUS', 'populationDescription': 'Subject lost to follow up, drop out or there was a change in the anesthetic technique during the surgical procedure.'}, {'title': 'Surgical Procedure Performed', 'classes': [{'title': 'Knee Arthroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}, {'value': '273', 'groupId': 'BG003'}]}]}, {'title': 'Shoulder Arthroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '112', 'groupId': 'BG003'}]}]}, {'title': 'Elbow Artrhroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': 'Other Arthroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}, {'title': 'Breast and skin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Hernia Repair', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Procedure of the eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Some subjects dropped out. Some of the planned anesthetic techniques were changed during the surgical procedure.'}, {'title': 'Perioperative opioid use', 'classes': [{'title': 'Intraoperative opioid (morEq milligrams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '8', 'upperLimit': '15'}, {'value': '10', 'groupId': 'BG001', 'lowerLimit': '6', 'upperLimit': '15'}, {'value': '10', 'groupId': 'BG002', 'lowerLimit': '5', 'upperLimit': '15'}, {'value': '10', 'groupId': 'BG003', 'lowerLimit': '5', 'upperLimit': '15'}]}]}, {'title': 'Postoperative opioid (morEq milligrams))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '6.7'}, {'value': '1.3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '3.8'}, {'value': '1.4', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '1.4', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '6.7'}]}]}, {'title': 'Total opioid (morEq milligrams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000', 'lowerLimit': '10', 'upperLimit': '21'}, {'value': '13', 'groupId': 'BG001', 'lowerLimit': '8', 'upperLimit': '18'}, {'value': '13', 'groupId': 'BG002', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '13', 'groupId': 'BG003', 'lowerLimit': '7', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'morphine equivalents milligrams', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Some subjects dropped out. Some anesthetic techniques were changed during the surgical procedure.'}, {'title': 'Time to discharge', 'classes': [{'title': 'Phase 1 immediate PACU (minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '54', 'upperLimit': '82'}, {'value': '63', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '79'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '70'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '50', 'upperLimit': '82'}]}]}, {'title': 'Phase 2 PACU transition home (minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000', 'lowerLimit': '70', 'upperLimit': '120'}, {'value': '95', 'groupId': 'BG001', 'lowerLimit': '70', 'upperLimit': '117'}, {'value': '95', 'groupId': 'BG002', 'lowerLimit': '65', 'upperLimit': '118'}, {'value': '93', 'groupId': 'BG003', 'lowerLimit': '65', 'upperLimit': '120'}]}]}, {'title': 'Time to discharge (minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '441', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'BG000', 'lowerLimit': '200', 'upperLimit': '295'}, {'value': '236', 'groupId': 'BG001', 'lowerLimit': '193', 'upperLimit': '281'}, {'value': '221', 'groupId': 'BG002', 'lowerLimit': '185', 'upperLimit': '283'}, {'value': '233', 'groupId': 'BG003', 'lowerLimit': '185', 'upperLimit': '296'}]}]}], 'paramType': 'MEDIAN', 'description': 'Time to discharge is the time admitted into the recovery phase 1 and discharged from the hospital.', 'unitOfMeasure': 'minutes', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'Some subjects were dropped from the study lost to follow up or the anesthetic management plan changed during the surgical procedure.'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-15', 'studyFirstSubmitDate': '2012-12-11', 'resultsFirstSubmitDate': '2017-04-16', 'studyFirstSubmitQcDate': '2012-12-11', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-15', 'studyFirstPostDateStruct': {'date': '2012-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Present With Postoperative Sore Throat', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications of sore throat as reported by the participant.'}, {'measure': 'The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphonia', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphonia. Difficulty in speaking as assessed by the study team and reported by the participant 24 hours after LMA airway placement.'}, {'measure': 'The Primary Outcomes for This Study Will be Postoperative Dysphagia.', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complication of dysphagia 24 hours after airway placement. This is assessed by a study team member during the 24 hour follow up or reported by the participant.'}, {'measure': 'The Primary Outcomes for This Study Will be Postoperative Pharyngolaryngeal Complications Including Dysphagia, Sore Throat and Dysphonia.', 'timeFrame': '24 hours', 'description': 'The primary outcomes for this study will be postoperative pharyngolaryngeal complications including dysphagia, sore throat and dysphonia 24 hours after airway placement.'}], 'secondaryOutcomes': [{'measure': 'Severity of Sore Throat', 'timeFrame': '24 hours', 'description': 'Severity of sore throat 24 hours after airway placement on a 11 point scale of 0-10 ( 0 equals no pain and 10 equals worst pain ever) per recovery hour.\n\nLow pain = 0 high pain= 500 composite score (0 to 11 points per hour x 24 hours)'}, {'measure': 'Blood on LMA After Removal', 'timeFrame': 'Immediately after LMA removal', 'description': 'Presence of blood immediately after the removal of the LMA after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intubation', 'Airway', 'Laryngeal Mask Airway'], 'conditions': ['Airway Morbidity']}, 'referencesModule': {'references': [{'pmid': '28590309', 'type': 'DERIVED', 'citation': 'Hu LQ, Leavitt OS, Malwitz C, Kim H, Doty RA Jr, McCarthy RJ. Comparison of laryngeal mask airway insertion methods, including the external larynx lift with pre-inflated cuff, on postoperative pharyngolaryngeal complications: A randomised clinical trial. Eur J Anaesthesiol. 2017 Jul;34(7):448-455. doi: 10.1097/EJA.0000000000000650.'}]}, 'descriptionModule': {'briefSummary': 'A laryngeal mask airway ("LMA") is an airway device that is commonly used and placed under general anesthesia to facilitate ventilation of the patient\'s lungs while anesthetized. It is similar to an "endotracheal tube" (a breathing tube) but is less invasive. It is also placed as a backup when the Anesthesiologist is unable to pass a breathing tube and the patient is not adequately ventilating. Unfortunately, an LMA may lead to complications similar to those of breathing tube placement, such as sore throat and hoarse voice. Previous studies have examined several variables that may affect how often complications occur; these variables include giving anti-inflammatory medications and inflating the LMA to different pressures (the "working" end of the LMA, which rests in the patient\'s throat, has a cuff that is inflated to provide a seal). We are studying the effect of the PLACEMENT TECHNIQUE on postoperative sore throat, hoarse voice, and difficulty swallowing. We will be using 3 placement techniques - the traditional placement technique, a slightly different traditional placement technique, and a new technique, abbreviated the "ELLIA" method. The hypothesis of this study is that a new LMA insertion technique will have no difference in postoperative pharyngolaryngeal morbidity including sore throat, dysphagia and dysphonia.', 'detailedDescription': "The LMA will be inserted based on one of three methods randomly assigned to each patient. The ELLIA technique involves gently lifting the patient's laryngeal structures (throat) while placing the LMA to oppose the force of gravity. Whereas the traditional method of placement involves guiding the LMA through the pharynx with a finger inserted into the pharynx, the ELLIA method avoids this step. General anesthesia will be maintained at the discretion of the Anesthesiologist throughout the surgical procedure. At the end of the case, as would normally occur, the LMA will be removed from the patient's airway and the patient will be taken to the PACU, where he or she will be cared for as usual. At one and two hours postoperatively, blinded research assistants will assess the patient for sore throat, hoarse voice, and difficulty swallowing. Finally, at 24 hours the patient will receive a telephone call from a blinded research assistant assessing for the same outcomes. These data will be collected and presented."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA (American Society of Anesthesiologists patient fitness category) I, II, III\n* Age 18-90\n* General anesthetic for where LMA (Laryngeal Mask Airway) placement is not contraindicated will be included\n\nExclusion Criteria:\n\n* Small mouth opening\n* Preoperative sore throat/dysphagia/dysphonia\n* Patients at increased risk for aspiration\n* Morbid obesity BMI \\> 40\n* Untreated chronic GERD\n* Pregnancy\n* Suspected supraglottic abnormalities\n* N2O use\n* Need for oral-pharyngeal suctioning\n* Undergoing oral and nasal surgery\n* Intubation or any oral instrumental manipulations other than\n* LMA placements intraoperatively or postoperatively'}, 'identificationModule': {'nctId': 'NCT01749033', 'briefTitle': 'A New Insertion Technique for Laryngeal Mask Airway', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A New Insertion Technique for Laryngeal Mask Airway', 'orgStudyIdInfo': {'id': 'STU00046964'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 classic', 'description': 'Group 1 Using the classic inserting technique and completely deflated LMA (Laryngeal Mask Airway)recommended in the LMA manual.', 'interventionNames': ['Other: Group 1 Classic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 pre inflated', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer', 'interventionNames': ['Other: Group 2 pre-inflated']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3 ELL-PIC technique', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique.', 'interventionNames': ['Other: Group 3 ELL-PIC']}], 'interventions': [{'name': 'Group 1 Classic', 'type': 'OTHER', 'description': 'Active Comparator: Group 1 classic\n\nGroup 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual.', 'armGroupLabels': ['Group 1 classic']}, {'name': 'Group 2 pre-inflated', 'type': 'OTHER', 'description': 'Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer.', 'armGroupLabels': ['Group 2 pre inflated']}, {'name': 'Group 3 ELL-PIC', 'type': 'OTHER', 'description': 'Group 3 (ELL-PIC): Using the ELL-PIC technique', 'armGroupLabels': ['Group 3 ELL-PIC technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'David Walega, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Walega', 'investigatorAffiliation': 'Northwestern University'}}}}