Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-27 @ 1:40 AM
Study NCT ID:
NCT04475250
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2020-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Train-of-four Monitoring Using the Tetragraph
Sponsor:
Organization:
Raw JSON
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Baseline TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) prior to administration of the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A lower TOFr equals stronger neuromuscular block and more muscle paralysis.'}, {'measure': 'Recovered TOFr (%)', 'timeFrame': 'At the end of surgery (maximum 7 hours from baseline)', 'description': 'Train of four (TOF) is measured by giving 4 quick electrical pulses to the muscle and counting the number of muscle twitches. Recovered TOFr is the ratio between the fourth twitch of the train of four (TOF) sequence (T4) and the first (T1) after recovery from the neuromuscular blocking agent and then multiplied by 100 to get a percentage. A TOFr greater than or equal to 90% indicates adequate recovery from the neuromuscular block.'}], 'secondaryOutcomes': [{'measure': 'Baseline Amplitude (mV)', 'timeFrame': 'Immediately prior to start of surgery', 'description': 'The amplitude of the muscle action potential prior to administration of the neuromuscular blocking agent.'}, {'measure': 'Recovered Amplitude (mV)', 'timeFrame': 'At the end of surgery (maximum 7 hours from baseline)', 'description': 'The amplitude of the muscle action potential after recovery from the neuromuscular blocking agent.'}, {'measure': 'Rate of Muscle Recovery (Minutes)', 'timeFrame': 'At the end of surgery (maximum 7 hours from baseline)', 'description': 'The amount of time it took to return to a TOFr \\>90% following reversal of neuromuscular blocking agent.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Surgery']}, 'referencesModule': {'references': [{'pmid': '38885397', 'type': 'DERIVED', 'citation': 'Tobias JD, Epstein RH, Rice-Weimer J, Yemele Kitio SA, Brull SJ, Kalsotra S. Pediatric Intraoperative Electromyographic Responses at the Adductor Pollicis and Flexor Hallucis Brevis Muscles: A Prospective, Comparative Analysis. Anesth Analg. 2024 Jul 1;139(1):36-43. doi: 10.1213/ANE.0000000000006926. Epub 2024 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective study that will evaluate the feasibility of using the Tetragraph Neuromuscular Transmission Monitor in comparison to standard (visual) train-of-four assessment with a peripheral nerve stimulator in pediatric patients undergoing surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric patients requiring anesthetic care and use of neuromuscular blockade\n* Weight range of 20 - 60 kg\n\nExclusion Criteria:\n\n* Patients with history of a peripheral neurologic or neuropathic disorder\n* Patients in whom the upper extremity cannot be used for TOF monitoring\n* Patients undergoing a surgical procedure in which neuromuscular blockade is not required\n* Edematous patients'}, 'identificationModule': {'nctId': 'NCT04475250', 'briefTitle': 'Train-of-four Monitoring Using the Tetragraph', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Train-of-four Monitoring Using the Tetragraph Neuromuscular Transmission Monitor and Comparison to Standard (Visual) Train-of-four Assessment With a Peripheral Nerve Stimulator', 'orgStudyIdInfo': {'id': 'STUDY00001075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetragraph', 'interventionNames': ['Device: Tetragraph (TM) NMT Monitor']}], 'interventions': [{'name': 'Tetragraph (TM) NMT Monitor', 'type': 'DEVICE', 'description': 'TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.', 'armGroupLabels': ['Tetragraph']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joseph D. Tobias', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chairman, Dept. of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}