Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT06023394
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2023-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Laryngeal Mask Airway in Laparoscopic Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'eweisberg@cmh.edu', 'phone': '9136605813', 'title': 'Dr. Emily Weisberg, pediatric anesthesiologist', 'organization': "Children's Mercy Kansas City"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During anesthetic time, defined as induction of anesthesia, to time of LMA or ETT removal documented by the anesthesia time, assessed up to 2 hours.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'OG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'classes': [{'title': 'SpO2 after placement airway device', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}, {'title': 'SpO2 5 minutes after surgery start', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}, {'title': 'SpO2 prior to airway device removal', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.', 'description': 'Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic', 'unitOfMeasure': 'Percent Saturation', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'End-tidal Carbon Dioxide Measured by Capnography in mm Hg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'OG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'classes': [{'title': 'ETCO2 after placement of airway device', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '50'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '41', 'upperLimit': '48'}]}]}, {'title': 'ETCO2 5 minutes after surgery start', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '49'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '42', 'upperLimit': '50'}]}]}, {'title': 'ETCO2 prior to removal of airway device', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '53'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '43', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours.', 'description': 'Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.', 'unitOfMeasure': 'millimeters mercury (mm Hg)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peak Airway Pressure Will be Measured in cm H2O', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'OG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'classes': [{'title': 'Peak airway pressure after placement of airway device', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '12'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '16'}]}]}, {'title': 'Peak airway pressure 5 minutes after surgery start', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '14'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '19'}]}]}, {'title': 'Peak airway pressure prior to removal of airway device', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '11'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '14'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.', 'description': 'Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.', 'unitOfMeasure': 'cm H20', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Documentation of Laryngospasm Occurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'OG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.', 'description': 'Will document if laryngospasm occurs in both groups at any time during the surgery.', 'unitOfMeasure': 'Presence of laryngospasm', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Documentation of Oxygen Desaturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'OG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.', 'description': 'Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.', 'unitOfMeasure': 'Occurence of oxygen desaturation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'FG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Surgery was not performed laparoscopically', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Surgery not performed (hernia not identified on diagnostic laparoscopy)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Did not receive allocated intervention (Patient received ETT per surgeon)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not received allocated intervention (no airway device documented in EMR)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.\n\nLaryngeal Mask Airway: Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.'}, {'id': 'BG001', 'title': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.\n\nEndotracheal Tube Device: Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', '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': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '5.4'}, {'value': '3.1', 'groupId': 'BG001', 'lowerLimit': '2.2', 'upperLimit': '4.8'}, {'value': '3.21', 'groupId': 'BG002', 'lowerLimit': '2.01', 'upperLimit': '4.95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-02-12', 'size': 626726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-24T11:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-08-04', 'resultsFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-02', 'studyFirstPostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxygen Saturation Measured by Pulse Oximetry in Percent Saturation', 'timeFrame': 'Patients will have oxygen saturation measured directly after placement airway device, the first oxygen saturation recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.', 'description': 'Oyxgen saturation will be measured by pulse oximetry in percent saturation at three time points during the anesthetic'}], 'secondaryOutcomes': [{'measure': 'End-tidal Carbon Dioxide Measured by Capnography in mm Hg', 'timeFrame': 'Patients will have end-tidal carbon dioxide measured directly after placement of device, the first end-tidal carbon dioxide measurement recorded five minutes after the start of surgery, and immediately prior to removal of device, assessed up to 2 hours.', 'description': 'Patients will have end-tidal carbon dioxide measured by capnography in mm Hg at three standardized time points during anesthesia.'}, {'measure': 'Peak Airway Pressure Will be Measured in cm H2O', 'timeFrame': 'Patients will have peak airway pressure measured directly after placement airway device, the first airway pressure recorded five minutes after the start of surgery, and immediately prior to removal airway device, assessed up to 2 hours.', 'description': 'Patients will have peak airway pressure in cm H2O measured at three standardized time points during anesthesia.'}, {'measure': 'Documentation of Laryngospasm Occurrence', 'timeFrame': 'Patients will have the occurrence of laryngospasm documented at any time point during the surgery, assessed up to 2 hours.', 'description': 'Will document if laryngospasm occurs in both groups at any time during the surgery.'}, {'measure': 'Documentation of Oxygen Desaturation', 'timeFrame': 'Patients will have the occurrence of oxygen desaturation documented if it occurs at any time point during the surgery, assessed up to 2 hours.', 'description': 'Will document if oxygen desaturation occurs at any time during the surgery as defined as an oxygen saturation of less than 90%.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Inguinal Hernia', 'Inguinal Hernia, Indirect', 'Inguinal Hernia Bilateral', 'Inguinal Hernia Unilateral']}, 'referencesModule': {'references': [{'pmid': '40381798', 'type': 'DERIVED', 'citation': 'Weisberg EL, Pieters BJ, Elman MS, Nonnemacher CJ, Noel-MacDonnell J, Oyetunji TA. The Use of Laryngeal Mask Airway Versus Endotracheal Intubation in Pediatric Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial. J Pediatr Surg. 2025 Aug;60(8):162367. doi: 10.1016/j.jpedsurg.2025.162367. Epub 2025 May 15.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized study will evaluate the effectiveness of laryngeal mask airway (LMA) versus endotracheal intubation (ETT) for patients undergoing laparoscopic inguinal hernia at CMH.', 'detailedDescription': 'This study aims to evaluate the effectiveness during general anesthesia of laryngeal mask airway versus endotracheal tube for laparoscopic inguinal hernia repair. There are limited pediatric literature evaluating the use of laryngeal mask airway for laparoscopic procedures compared with traditional endotracheal intubation. This study aims to add to this literature in providing information comparing the two techniques. The rationale for this study is to show that general anesthesia with laryngeal mask airway is an effective and non-inferior technique compared with general anesthesia with endotracheal intubation in pediatric patients undergoing laparoscopic inguinal hernia repair and may offer benefits in terms of efficiency of care and respiratory complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '12 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic inguinal hernia repair.\n* Ages 12 months to 8 years of age\n* American Society of Anesthesiologists Physical Status Classification ASA 1 or 2\n* ASA 1- A normal, healthy patient\n* ASA 2- A patient with mild systemic disease\n* Elective with appropriate NPO status\n* English speakers\n* Spanish speakers\n\nExclusion Criteria:\n\n* Patients with current gastroesophageal reflux\n* Obesity (CDC \\>= 95th %ile)\n* Contraindications to study protocol medications'}, 'identificationModule': {'nctId': 'NCT06023394', 'briefTitle': 'Laryngeal Mask Airway in Laparoscopic Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': "Children's Mercy Hospital Kansas City"}, 'officialTitle': 'Laryngeal Mask Airway Versus Endotracheal Intubation for Laparoscopic Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'Study00002580'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort A: Receives Laryngeal Mask Airway Device', 'description': 'In this study arm, after induction of general anesthesia, the patients will receive a laryngeal mask airway device.', 'interventionNames': ['Device: Laryngeal Mask Airway']}, {'type': 'OTHER', 'label': 'Cohort B: Receives Endotracheal Tube Device', 'description': 'In this arm, after induction of general anesthesia, the patients will receive an endotracheal tube airway device.', 'interventionNames': ['Device: Endotracheal Tube Device']}], 'interventions': [{'name': 'Laryngeal Mask Airway', 'type': 'DEVICE', 'description': 'Laryngeal mask airway will be used as an airway device for Cohort A in the standard fashion.', 'armGroupLabels': ['Cohort A: Receives Laryngeal Mask Airway Device']}, {'name': 'Endotracheal Tube Device', 'type': 'DEVICE', 'description': 'Endotracheal tube airway will be used as an airway device for Cohort B in the standard fashion.', 'armGroupLabels': ['Cohort B: Receives Endotracheal Tube Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Mercy Hospital Kansas City", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physican, M.D.', 'investigatorFullName': 'Emily Weisberg', 'investigatorAffiliation': "Children's Mercy Hospital Kansas City"}}}}