Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04352127
Status:
COMPLETED
Last Update Posted:
2022-11-10
First Post:
2020-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve
Sponsor:
Organization:
Raw JSON
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Ross Renew, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events will be collected from baseline to end of study, approximately 1 hour', 'eventGroups': [{'id': 'EG000', 'title': 'Dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjective Evaluation to Neurostimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}, {'id': 'OG001', 'title': 'Non-dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000'}, {'value': '44.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 hour postoperatively', 'description': 'The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.', 'unitOfMeasure': 'percentage of evaluations', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Residual Neuromuscular Blockade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}, {'id': 'OG001', 'title': 'Non-dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'Number of subjects with train of four ratio \\< 0.9 after administration of reversal agent.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}, {'id': 'FG001', 'title': 'Non-dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Unable to obtain readings', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'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': 'Dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}, {'id': 'BG001', 'title': 'Non-dominant Hand', 'description': 'Subjects underwent an elective surgical procedure and had a TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand\n\nTetraGraph: FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '16.2', 'groupId': 'BG001'}, {'value': '57.9', 'spread': '14.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics were not collected for the Anesthesia providers'}, {'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': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics were not collected for the Anesthesia providers'}, {'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'}], 'populationDescription': 'Baseline characteristics was not collected for the Anesthesia providers'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-13', 'size': 649234, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-06T10:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2020-04-16', 'resultsFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2020-04-16', 'lastUpdatePostDateStruct': {'date': '2022-11-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-12', 'studyFirstPostDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Evaluation to Neurostimulation', 'timeFrame': 'up to 1 hour postoperatively', 'description': 'The percentage of subjective evaluations that overestimated the response of the adductor pollicis muscle following neurostimulation of the ulnar nerve when compared to objective measurements.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Residual Neuromuscular Blockade', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'Number of subjects with train of four ratio \\< 0.9 after administration of reversal agent.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Neuromuscular Blockade', 'Tetragraph', 'AMG', 'EMG'], 'conditions': ['Residual Neuromuscular Blockade']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> or = 18 years old\n* Patients willing to participate and provide an informed consent\n* Patients undergoing an elective surgical procedure that requires use of NMBA agents administered intraoperatively.\n\nExclusion Criteria:\n\n* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.\n* Patients with systemic neuromuscular diseases such as myasthenia gravis\n* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.\n* Patients having surgery that would involve prepping the arm or leg into the sterile field'}, 'identificationModule': {'nctId': 'NCT04352127', 'briefTitle': 'Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve', 'orgStudyIdInfo': {'id': '20-000619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dominant hand', 'description': 'Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and routine clinical monitor on non-dominant hand', 'interventionNames': ['Device: TetraGraph']}, {'type': 'EXPERIMENTAL', 'label': 'Non-dominant hand', 'description': 'Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the non-dominant hand and routine clinical monitor on dominant hand', 'interventionNames': ['Device: TetraGraph']}], 'interventions': [{'name': 'TetraGraph', 'type': 'DEVICE', 'description': 'FDA approved neuromuscular transmission monitor capable of measuring the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to electrical neurostimulation via skin electrodes.', 'armGroupLabels': ['Dominant hand', 'Non-dominant hand']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic in Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'J.Ross Renew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'J. Ross Renew, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}