Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT03052894
Status:
TERMINATED
Last Update Posted:
2019-12-17
First Post:
2017-02-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Muscle Relaxation Monitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Data collection issues from the electronic health record.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2017-02-10', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Hydraulic Twitch Monitoring Device in Measuring Neuromuscular Blockade as Compared to EMG Monitoring Device, Assessed using Repeated Measures Bland-Altman Analysis', 'timeFrame': '12 months', 'description': 'To determine the accuracy (bias and precision) of a the monitoring device as compared to the electromyographic (EMG) monitor in measuring the extent of neuromuscular blockade in subjects undergoing general anesthesia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['anesthesiology', 'neuromuscular blockade', 'monitoring device'], 'conditions': ['Neuromuscular Blockade']}, 'referencesModule': {'references': [{'pmid': '1952146', 'type': 'RESULT', 'citation': 'Brull SJ, Silverman DG. Visual assessment of train-of-four and double burst-induced fade at submaximal stimulating currents. Anesth Analg. 1991 Nov;73(5):627-32. doi: 10.1213/00000539-199111000-00020.'}, {'pmid': '4037404', 'type': 'RESULT', 'citation': 'Viby-Mogensen J, Jensen NH, Engbaek J, Ording H, Skovgaard LT, Chraemmer-Jorgensen B. Tactile and visual evaluation of the response to train-of-four nerve stimulation. Anesthesiology. 1985 Oct;63(4):440-3. doi: 10.1097/00000542-198510000-00015. No abstract available.'}, {'pmid': '20442261', 'type': 'RESULT', 'citation': 'Brull SJ, Murphy GS. Residual neuromuscular block: lessons unlearned. Part II: methods to reduce the risk of residual weakness. Anesth Analg. 2010 Jul;111(1):129-40. doi: 10.1213/ANE.0b013e3181da8312. Epub 2010 May 4.'}, {'pmid': '4254032', 'type': 'RESULT', 'citation': 'Ali HH, Utting JE, Gray TC. Quantitative assessment of residual antidepolarizing block. II. Br J Anaesth. 1971 May;43(5):478-85. doi: 10.1093/bja/43.5.478. No abstract available.'}, {'pmid': '10754616', 'type': 'RESULT', 'citation': 'Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.'}, {'pmid': '9105219', 'type': 'RESULT', 'citation': 'Kopman AF, Yee PS, Neuman GG. Relationship of the train-of-four fade ratio to clinical signs and symptoms of residual paralysis in awake volunteers. Anesthesiology. 1997 Apr;86(4):765-71. doi: 10.1097/00000542-199704000-00005.'}, {'pmid': '9366453', 'type': 'RESULT', 'citation': 'Eriksson LI, Sundman E, Olsson R, Nilsson L, Witt H, Ekberg O, Kuylenstierna R. Functional assessment of the pharynx at rest and during swallowing in partially paralyzed humans: simultaneous videomanometry and mechanomyography of awake human volunteers. Anesthesiology. 1997 Nov;87(5):1035-43. doi: 10.1097/00000542-199711000-00005.'}, {'pmid': '9366929', 'type': 'RESULT', 'citation': 'Berg H, Roed J, Viby-Mogensen J, Mortensen CR, Engbaek J, Skovgaard LT, Krintel JJ. Residual neuromuscular block is a risk factor for postoperative pulmonary complications. A prospective, randomised, and blinded study of postoperative pulmonary complications after atracurium, vecuronium and pancuronium. Acta Anaesthesiol Scand. 1997 Oct;41(9):1095-1103. doi: 10.1111/j.1399-6576.1997.tb04851.x.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the accuracy of a hydraulically coupled twitch monitor compared to the EMG twitch monitor in current use to measure the extent of neuromuscular blockade in patients undergoing general anesthesia.', 'detailedDescription': 'Neuromuscular blockade (paralysis) is necessary for many surgical procedures to provide optimal surgical conditions. The extent of paralysis typically assessed during routine clinical care by examining the muscle response of the thumb ("twitch") following delivery of a series of the "train-of-four".\n\nQuantitative assessment of neuromuscular block can be assessed using electromyography (EMG) This technique measures action potential in the muscles of the thumb.\n\nThe proposed method is a simple technique that can constructed with equipment that is readily available in most operating rooms. If validated, it would provide a simple method to assess quantitatively the extent of neuromuscular blockade and recovery of muscle strength.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. Age \\>18\n2. Surgery is elective\n3. Subject has been NPO for fluids for \\>2 hours and for solids \\>8 hours\n4. General anesthesia with tracheal intubation is required\n5. Mask ventilation is expected to be without difficulty\n6. Subject voluntarily consents in writing to the protocol\n7. ASA Physical Status 1-III (healthy individuals, those with mild comorbid conditions, or those with more serious co-morbid conditions that are well controlled)\n\nExclusion Criteria:\n\n1. Lack of ability to provide written, informed consent\n2. Airway examination indicates a likelihood of difficult mask ventilation\n3. Symptoms of active reflux at the time of induction, at risk of having food in their stomach at the time of induction, expected abnormal response to non-depolarizing neuromuscular blockers\n4. Age ≤18 years\n5. Pregnant women\n6. Presence of carpal tunnel syndrome\n7. Prisoners\n8. General anesthesia not being provided\n9. Tracheal intubation will not be performed\n10. Anticipated length of surgery \\<60 minutes\n11. Emergent or urgent surgery\n12. Disease that might alter the normal neuromuscular response to electrical stimulation (e.g., muscular dystrophies, myasthenia gravis, quadriplegia).\n13. ASA Physical Status IV or V (individuals with major comorbid conditions that are a constant source of risk to health)'}, 'identificationModule': {'nctId': 'NCT03052894', 'briefTitle': 'Validation of a Muscle Relaxation Monitor', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Validation of a Device to Monitor Muscle Relaxation During Surgery', 'orgStudyIdInfo': {'id': '20161018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydraulic Monitoring Device', 'description': 'Monitoring device to be compared to electromyographic (EMG) device in the same patient; measures depth of neuromuscular blockade during general anesthesia based on the pressure exerted by the muscles of the thumb.', 'interventionNames': ['Device: Hydraulic Monitoring Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard EMG Monitoring Device', 'description': 'Currently used standard monitoring device; measures depth of neuromuscular blockade during general anesthesia based on the action potential of the muscles of the thumb.', 'interventionNames': ['Device: Standard EMG Monitoring Device']}], 'interventions': [{'name': 'Hydraulic Monitoring Device', 'type': 'DEVICE', 'description': 'The hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia.\n\nThis will be compared to measurements using a current monitoring device in the same patient.', 'armGroupLabels': ['Hydraulic Monitoring Device']}, {'name': 'Standard EMG Monitoring Device', 'type': 'DEVICE', 'description': 'Standard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia.\n\nThis will be used as the clinical monitoring device and as a comparator.', 'armGroupLabels': ['Standard EMG Monitoring Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Department of Anesthesiology at University of Miami Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Richard Epstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Richard H Epstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society for Technology in Anesthesia', 'class': 'UNKNOWN'}, {'name': 'University of Miami', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Clinical Anesthesiology', 'investigatorFullName': 'Richard H Epstein', 'investigatorAffiliation': 'University of Miami'}}}}