Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT04518761
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2020-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017558', 'term': 'Elective Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2020-08-14', 'studyFirstSubmitQcDate': '2020-08-14', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOF-ratio', 'timeFrame': '1 day', 'description': 'Train of four percentage'}], 'secondaryOutcomes': [{'measure': 'TOF-count', 'timeFrame': '1 day', 'description': 'Train of four count'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analyse Neuromuscular Monitoring for Developing a Model to Predict TOF Ratio During Anesthesia']}, 'referencesModule': {'references': [{'pmid': '38573367', 'type': 'DERIVED', 'citation': 'Verdonck M, Carvalho H, Fuchs-Buder T, Brull SJ, Poelaert J. Machine learning based analysis and detection of trend outliers for electromyographic neuromuscular monitoring. J Clin Monit Comput. 2024 Oct;38(5):1163-1173. doi: 10.1007/s10877-024-01141-6. Epub 2024 Apr 4.'}, {'pmid': '37542918', 'type': 'DERIVED', 'citation': "Carvalho H, Verdonck M, Eleveld DJ, Ramirez D, D'Haese J, Flamee P, Geerts L, Wylleman J, Cools W, Barbe K, Struys MMRF, Poelaert J. Neuromuscular end-point predictive capability of published rocuronium pharmacokinetic/pharmacodynamic models: An observational trial. J Clin Anesth. 2023 Nov;90:111225. doi: 10.1016/j.jclinane.2023.111225. Epub 2023 Aug 3."}]}, 'descriptionModule': {'briefSummary': 'Neuromuscular Blocking Agents (NMBAs) are routinely administered to patients in a multiplicity o anaesthetic settings in order to paralyze and impede (re)active muscular contraction. The availability of monitoring devices allowing an accurate measurement fo the degree of neuromuscular block during anesthesia has raised the standards for a proper evidence-based use of NMBAs.\n\nFor this purpose, one of the most widely used methods is the Train of Four (TOF): transcutaneous application of a series of 4 square-wave supra-maximal electrical stimuli over the course of a nerve of choice (most commonly the ulnar nerve). These are applied at a frequency of 2Hz, and each with a duration of 0.2ms. These stimuli elicit a motor response on the adductor pollicis muscle, which on its turn dictates the adduction of the thumb. The acceleration of this movement can be followed by means of an uni/multi-directional accelerometer attached to the thumb. The ratio of the acceleration of the 4th and 1st elicited contractions is called the TOF-Ratio - a clinically and scientifically established method of assessing neuromuscular block recovery. A value of 1 translates a full recovery of the muscular function of a patient. In modern Anesthesia, the bar for deeming a recovery as adequate has been set at a minimum of a TOF-ratio of \\>0.9, with some authors advocating a ratio of 1 as the only acceptable and complications avoiding result.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (18 years old and above) receiving General Anesthesia for noncardiac surgery requiring the use of a neuromuscular blocking agent.\n* Administration of General Anesthesia by means of Total Intravenous Anesthesia technique.\n* Use of Rocuronium as a neuromuscular blocking agent.\n\nExclusion Criteria:\n\n* Use of different types of neuromuscular blocking agents for the same patient within the same surgical procedure\n* Known Neuromuscular diseases/syndromes judged to condition accurate neuromuscular monitoring.'}, 'identificationModule': {'nctId': 'NCT04518761', 'briefTitle': 'Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Predictive Modelling of the Intraoperative Train-of-Four (TOF) Ratio', 'orgStudyIdInfo': {'id': 'TOFPROS02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prospective group', 'interventionNames': ['Procedure: Elective surgery']}, {'label': 'Retrospective group', 'interventionNames': ['Procedure: Elective surgery']}], 'interventions': [{'name': 'Elective surgery', 'type': 'PROCEDURE', 'description': 'Any patient who needs to undergo an elective surgery.', 'armGroupLabels': ['Prospective group', 'Retrospective group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Evelien Vandeurzen, Biomedical Sciences', 'role': 'CONTACT', 'email': 'evelien.vandeurzen@uzbrussel.be', 'phone': '024749237'}, {'name': 'Hugo Carvalho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UZ Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '8000', 'city': 'Bruges', 'state': 'WV', 'status': 'NOT_YET_RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Hugo Carvalho, MD, PhD', 'role': 'CONTACT'}, {'name': 'Hugo Carvalho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AZ Sint Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Publication via medical article.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}