Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2026-01-11 @ 6:58 PM
Study NCT ID:
NCT03829618
Status:
TERMINATED
Last Update Posted:
2021-10-12
First Post:
2019-01-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Sponsor:
Organization:
Raw JSON
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{'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'znisnevitchsavarese@pennstatehealth.psu.edu', 'phone': '717-531-6597', 'title': 'Zoulfira Nisnevitch-Savarese, M.D.', 'organization': 'Penn State Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The target enrollment was not reached secondary to the COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'Data collected in the post-anesthesia care unit up to 1 hour after procedure', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Nebuliser Suspension', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 0, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'OG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl', 'unitOfMeasure': 'coughs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-procedure Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 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'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'moderate', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'sore throat was self reported by patient as: none, mild, moderate, severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population does not include subjects who left clinic prior to collection of this data'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-Procedure Subjective Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'OG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'classes': [{'categories': [{'title': 'none', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'mild', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}, {'title': 'moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}, {'title': 'severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Subjective cough as described by patient as: none, mild, moderate, severe', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population does not include subjects who left clinic prior to collection of this data.'}, {'type': 'SECONDARY', 'title': 'Anesthesia Time to Wake up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'OG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'classes': [{'categories': [{'measurements': [{'value': '8.47', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '13.00', 'spread': '5.77', 'groupId': 'OG001'}, {'value': '6.14', 'spread': '3.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'time in minutes from scope out until ready for transport to post anesthesia care unit', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alfentanyl Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten 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'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'OG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'classes': [{'categories': [{'measurements': [{'value': '5.30', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '6.93', 'spread': '3.36', 'groupId': 'OG001'}, {'value': '3.26', 'spread': '0.81', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Total propofol dosing by anesthesia in mg/kg', 'unitOfMeasure': 'mg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fentanyl Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'OG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'OG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.30', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.24', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.39', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'total fentanyl dosing by anesthesia in mcg/kg', 'unitOfMeasure': 'mcg/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'FG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'FG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants will be Identified from pool of patients who will already be undergoing with planned flexible bronchoscopy and/or endobronchial ultrasound by an interventional pulmonologist in the operating room setting. They will be identified by review of the operating room schedule and through the interventional pulmonology clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.\n\nTopical lidocaine: 1% lidocaine topically applied in 4 mL aliquots'}, {'id': 'BG001', 'title': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.\n\nNebuliser solution: 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer'}, {'id': 'BG002', 'title': 'Atomizer Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.\n\nNebuliser Suspension: 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.80', 'spread': '12.81', 'groupId': 'BG000'}, {'value': '55.57', 'spread': '16.83', 'groupId': 'BG001'}, {'value': '57.43', 'spread': '14.77', 'groupId': 'BG002'}, {'value': '61.83', 'spread': '14.75', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '30.19', 'spread': '6.93', 'groupId': 'BG000'}, {'value': '29.39', 'spread': '4.84', 'groupId': 'BG001'}, {'value': '28.53', 'spread': '8.23', 'groupId': 'BG002'}, {'value': '29.59', 'spread': '6.63', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking History', 'classes': [{'categories': [{'title': 'currently smoking', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'quit smoking', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'never smoked', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-10', 'size': 206813, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-08-19T14:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'whyStopped': 'COVID lack of cases/recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-08', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2019-02-01', 'lastUpdatePostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-08', 'studyFirstPostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough', 'timeFrame': '1 day', 'description': 'Number of coughs during procedure as defined by cough requiring stopping procedure or treatment by anesthesiologist with propofol or alfentanyl'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Post-procedure Sore Throat', 'timeFrame': '1 day', 'description': 'sore throat was self reported by patient as: none, mild, moderate, severe'}, {'measure': 'Number of Participants With Post-Procedure Subjective Cough', 'timeFrame': '1 day', 'description': 'Subjective cough as described by patient as: none, mild, moderate, severe'}, {'measure': 'Anesthesia Time to Wake up', 'timeFrame': '1 day', 'description': 'time in minutes from scope out until ready for transport to post anesthesia care unit'}, {'measure': 'Alfentanyl Dosing', 'timeFrame': '1 day', 'description': 'Total alfentanyl dosing by anesthesia in mcg/kg'}, {'measure': 'Propofol Dosing', 'timeFrame': '1 day', 'description': 'Total propofol dosing by anesthesia in mg/kg'}, {'measure': 'Fentanyl Dosing', 'timeFrame': '1 day', 'description': 'total fentanyl dosing by anesthesia in mcg/kg'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis Adult', 'Mediastinal Lymphadenopathy', 'Pneumonia', 'Chest--Diseases', 'Infiltrates', 'Bronchopulmonary Disease', 'Cancer, Lung']}, 'referencesModule': {'references': [{'pmid': '29346249', 'type': 'BACKGROUND', 'citation': 'Madan K, Biswal SK, Mittal S, Hadda V, Mohan A, Khilnani GC, Pandey RM, Guleria R. 1% Versus 2% Lignocaine for Airway Anesthesia in Flexible Bronchoscopy Without Lignocaine Nebulization (LIFE): A Randomized Controlled Trial. J Bronchology Interv Pulmonol. 2018 Apr;25(2):103-110. doi: 10.1097/LBR.0000000000000458.'}, {'pmid': '16162784', 'type': 'BACKGROUND', 'citation': 'Stolz D, Chhajed PN, Leuppi J, Pflimlin E, Tamm M. Nebulized lidocaine for flexible bronchoscopy: a randomized, double-blind, placebo-controlled trial. Chest. 2005 Sep;128(3):1756-60. doi: 10.1378/chest.128.3.1756.'}, {'pmid': '22045879', 'type': 'BACKGROUND', 'citation': 'Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.'}, {'pmid': '27614989', 'type': 'BACKGROUND', 'citation': 'Dreher M, Cornelissen CG, Reddemann MA, Muller A, Hubel C, Muller T. Nebulized versus Standard Local Application of Lidocaine during Flexible Bronchoscopy: A Randomized Controlled Trial. Respiration. 2016;92(4):266-273. doi: 10.1159/000449135. Epub 2016 Sep 10.'}, {'pmid': '28891835', 'type': 'RESULT', 'citation': 'Amini S, Peiman S, Khatuni M, Ghalamkari M, Rahimi B. The Effect of Dextromethorphan Premedication on Cough and Patient Tolerance During Flexible Bronchoscopy: A Randomized, Double-blind, Placebo-controlled Trial. J Bronchology Interv Pulmonol. 2017 Oct;24(4):263-267. doi: 10.1097/LBR.0000000000000385.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess if there is decrease in cough during flexible bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration are used. The modes of administration being evaluated are topical, nebulized and atomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial ultrasound evaluation and transbronchial needle aspiration.\n* Diagnosis of pulmonary disease requiring flexible bronchoscopy\n* Greater than 18 years of age.\n\nExclusion Criteria:\n\n* Any intervention beyond flexible bronchoscopy and endobronchial ultrasound\n* Inability to tolerate bronchoscopy.\n* Patients that receive paralytics.\n* Patients with neuromuscular diseases.\n* Inability to consent for procedures.\n* Allergies to lidocaine or any other drugs used in protocol.\n* Existing renal insufficiency or liver disease'}, 'identificationModule': {'nctId': 'NCT03829618', 'briefTitle': 'Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound', 'orgStudyIdInfo': {'id': 'STUDY00009727'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topical Lidocaine', 'description': '16 ml of 1% lidocaine sprayed in 4 ml aliquots to vocal cords, midtrachea, left main stem bronchus and right main stem bronchus.', 'interventionNames': ['Drug: Topical lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nebuliser Solution', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via jet nebulizer in operating room over ten minutes.', 'interventionNames': ['Drug: Nebuliser solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nebuliser Suspension', 'description': '2% lidocaine dosed at 2mg/kg with max dose of 160mg nebulized via vibrating mesh nebulizer in operating room over ten minutes.', 'interventionNames': ['Drug: Nebuliser Suspension']}], 'interventions': [{'name': 'Topical lidocaine', 'type': 'DRUG', 'otherNames': ['Topical'], 'description': '1% lidocaine topically applied in 4 mL aliquots', 'armGroupLabels': ['Topical Lidocaine']}, {'name': 'Nebuliser solution', 'type': 'DRUG', 'otherNames': ['Nebulizer'], 'description': '2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer', 'armGroupLabels': ['Nebuliser Solution']}, {'name': 'Nebuliser Suspension', 'type': 'DRUG', 'otherNames': ['Atomizer'], 'description': '2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer', 'armGroupLabels': ['Nebuliser Suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17036', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Jennifer Toth', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Surgery, Director of Interventional Pulmonology', 'investigatorFullName': 'Jennifer Toth', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}