Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT05964166
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2023-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tetragraph® Monitor: Tolerance of Preoperative Placement
Sponsor:
Organization:
Raw JSON
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[{'value': '14', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '0.98', 'groupId': 'BG000', 'lowerLimit': '0.61', 'upperLimit': '4.89'}, {'value': '5.24', 'groupId': 'BG001', 'lowerLimit': '0.77', 'upperLimit': '8.71'}, {'value': '3.70', 'groupId': 'BG002', 'lowerLimit': '0.72', 'upperLimit': '7.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 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'BG002'}]}]}, {'title': 'ASA II', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'ASA III', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "American Society of Anesthesiologists classification system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. 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The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients requiring anesthetic care and use of neuromuscular blockade\n2. Age ≤ 12 years\n3. ASA 1-4\n\nExclusion Criteria:\n\n1. History of a peripheral neurologic or neuropathic disorder\n2. Upper extremity cannot be used for TOF monitoring\n3. Undergoing a surgical procedure in which neuromuscular blockade is not required\n4. Patient is edematous\n5. Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor'}, 'identificationModule': {'nctId': 'NCT05964166', 'briefTitle': 'Tetragraph® Monitor: Tolerance of Preoperative Placement', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Tetragraph® Monitor: Tolerance of Preoperative Placement', 'orgStudyIdInfo': {'id': 'STUDY00003295'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tetragraph', 'interventionNames': ['Device: TetraGraph NMT Monitor']}], 'interventions': [{'name': 'TetraGraph 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': 'Chief of Anesthesiology & Pain Medicine', 'investigatorFullName': 'Joseph D. Tobias', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}