Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 4:51 PM
Study NCT ID:
NCT04312256
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2020-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thumb vs Great Toe Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Renew.J@mayo.edu', 'phone': '904-956-3328', 'title': 'J. Ross Renew, M.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from baseline to end of study, approximately one hour', 'eventGroups': [{'id': 'EG000', 'title': 'Dominant Hand and Great Toe', 'description': 'Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.\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 (ECG) electrodes.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexor Hallucis Brevis (Great Toe)', 'description': 'TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.'}, {'id': 'OG001', 'title': 'Adductor Pollicis (Thumb)', 'description': 'TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '540.0'}, {'value': '180.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '840.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexor Hallucis Brevis (Great Toe)', 'description': 'TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.'}, {'id': 'OG001', 'title': 'Adductor Pollicis (Thumb)', 'description': 'TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '180', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1020'}, {'value': '180', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '660'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed in18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.'}, {'type': 'SECONDARY', 'title': 'Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexor Hallucis Brevis (Great Toe)', 'description': 'TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.'}, {'id': 'OG001', 'title': 'Adductor Pollicis (Thumb)', 'description': 'TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '540.0'}, {'value': '180.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '840.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Flexor Hallucis Brevis (Great Toe)', 'description': 'TetraGraph monitoring flexor hallucis brevis (great toe) muscle for all subjects.'}, {'id': 'OG001', 'title': 'Adductor Pollicis (Thumb)', 'description': 'TetraGraph monitoring adductor pollicis (thumb) muscle for all subjects.'}], 'classes': [{'categories': [{'measurements': [{'value': '180.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1020.0'}, {'value': '180.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '660.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected nor analyzed in 18 subjects great toes. Data was not collected nor analyzed in 13 subjects thumbs.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dominant Hand and Great Toe', 'description': 'Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.\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 (ECG) electrodes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dominant Hand and Great Toe', 'description': 'Subjects who underwent an elective surgical procedure had TetraGraph device lead placement on the dominant hand and great toe.\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 (ECG) electrodes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'spread': '13.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '73', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-15', 'size': 616312, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-09T16:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2020-03-16', 'resultsFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2020-03-16', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-11-15', 'studyFirstPostDateStruct': {'date': '2020-03-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset Time of Muscle Relaxation for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time before initial muscle relaxation is recorded via neurostimulation with the Tetragraph device. As measure in seconds.'}, {'measure': 'Recover Time for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time after muscle neurostimulation with the Tetragraph device completion to muscle full recovery. As measure in seconds.'}], 'secondaryOutcomes': [{'measure': 'Onset Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time from reversal agent administered to initial muscle relaxation increase recorded via neurostimulation with the Tetragraph device. As measure in seconds.'}, {'measure': 'Recover Time of Reversal Agent Administered for Flexor Hallucis Brevis (Great Toe) and Adductor Pollicis (Thumb) Muscles', 'timeFrame': 'Up to 1 hour postoperatively', 'description': 'The amount of time after reversal agent administered to muscle full recovery recorded via neurostimulation with the Tetragraph device. As measure in seconds.'}]}, 'oversightModule': {'oversightHasDmc': False, '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': 'Researches are comparing the accuracy of measuring muscle relaxation in the thumb versus the great toe.'}, '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 non-depolarizing NMBA agents administered intraoperatively.\n* Patients with planned administration of sugammadex as a neuromuscular blocking reversal agent.\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': 'NCT04312256', 'briefTitle': 'Thumb vs Great Toe Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Flexor Hallicus Brevis and Adductor Pollicis as Sites for Neuromuscular Monitoring With Electromyography (Thumb vs Great Toe) After Sugammadex Administration', 'orgStudyIdInfo': {'id': '19-011705'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dominant Hand and great toe', 'description': 'Subject scheduled to undergo an elective surgical procedure will have TetraGraph device lead placement on the dominant hand and great toe.', '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 (ECG) electrodes.', 'armGroupLabels': ['Dominant Hand and great toe']}]}, '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'}}}}