Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-30 @ 3:33 AM
Study NCT ID:
NCT05583032
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2022-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2022-10-13', 'studyFirstSubmitQcDate': '2022-10-13', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block identification (long-term)', 'timeFrame': '8-10 weeks', 'description': "Identification of an appropriate block view by participant \\[blinded expert's opinion; Y/N\\] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (8 - 10 weeks after teaching)"}], 'secondaryOutcomes': [{'measure': 'Block identification (immediate)', 'timeFrame': 'Time 0', 'description': "Identification of an appropriate block view by participant \\[blinded expert's opinion; Y/N\\] both with and without the use of ScanNav Anatomy PNB for ultrasound scanning (immediately after teaching)"}, {'measure': 'Anatomy identification', 'timeFrame': 'Time 0 and 8-10 weeks', 'description': 'Correct identification of anatomical structures on the block view \\[Y/N\\]'}, {'measure': 'Participant confidence', 'timeFrame': 'Time 0 and 8-10 weeks', 'description': 'Participant confidence in ultrasound scanning \\[continuous scale; 0 (no confidence\\] - 10 (total confidence)\\]'}, {'measure': 'Overall scan performance', 'timeFrame': 'Time 0 and 8-10 weeks', 'description': "Expert observer's assessment of the participant's overall ultrasound scanning performance \\[continuous scale; 0 (poor) - 10 (excellent)\\]"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ScanNav', 'Anatomy PNB'], 'conditions': ['Ultrasound Imaging of Anatomical Structures']}, 'referencesModule': {'references': [{'pmid': '39430867', 'type': 'DERIVED', 'citation': "Kowa CY, Morecroft M, Macfarlane AJR, Burckett-St Laurent D, Pawa A, West S, Margetts S, Haslam N, Ashken T, Sebastian MP, Thottungal A, Womack J, Noble JA, Higham H, Bowness JS. Prospective randomized evaluation of the sustained impact of assistive artificial intelligence on anesthetists' ultrasound scanning for regional anesthesia. BMJ Surg Interv Health Technol. 2024 Oct 16;6(1):e000264. doi: 10.1136/bmjsit-2024-000264. eCollection 2024."}]}, 'descriptionModule': {'briefSummary': "A randomised, blinded interventional prospective study evaluating the long-term impact of assistive artificial intelligence on anaesthetists' ultrasound scanning for regional anaesthesia.", 'detailedDescription': 'This is a randomised, blinded interventional prospective study which will be conducted and reported as per the Consolidated Standards of Reporting Trials - Artificial Intelligence (CONSORT-AI) guidance. The study end points have been defined prospectively, and data will be divided into two cohorts (with vs without ScanNav Anatomy PNB assistance). Participants will be asked to perform ultrasound (US) scanning on healthy volunteers while under observation by a subject matter expert (expert observer) who will assess participant performance, both with and without the device. The US scans will be recorded and blinded expert observers (without knowledge of whether ScanNav Anatomy PNB is in use) will also assess acquisition of an appropriate block view (panel of three experts, one viewing each scan as per the unblinded assessors). The initial assessment will be undertaken after a scanning tutorial and then repeated after 8-10 weeks (to assess longer-term impact of the device).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '70 participants will be recruited to represent the intended user population (anaesthetists qualified to perform UGRA, but non-experts in the field of regional anaesthesia).\n\nPotential study participants will be identified by approaching professional anaesthesia/anaesthetics societies, networks (e.g., Wales Regional Anaesthesia Group - South).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Anaesthetist in Stage 1 of UK Anaesthesia Core/Specialty Training (CT 1-3)\n2. Able to comprehend and sign the Informed Consent prior to enrolment in the study\n3. Available to travel and attend the study day in person\n\nExclusion Criteria:\n\n1. Aged \\<18 years of age\n2. Unwilling or unable to provide informed consent\n3. Expert in UGRA (see definition above)'}, 'identificationModule': {'nctId': 'NCT05583032', 'briefTitle': "An Evaluation of the Long-Term Impact of Assistive AI on Anaesthetists' Ultrasound Scanning for UGRA", 'organization': {'class': 'INDUSTRY', 'fullName': 'IntelligentUltrasound Limited'}, 'officialTitle': "A Randomised Prospective Evaluation of the Long-Term Impact of Assistive Artificial Intelligence on Anaesthetists' Ultrasound Scanning for Regional Anaesthesia", 'orgStudyIdInfo': {'id': 'IU2022_AG_10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ScanNav Anatomy PNB aided', 'description': 'Participants completing scans for regional anaesthesia with the aid of ScanNav Anatomy PNB.', 'interventionNames': ['Device: ScanNav Anatomy PNB']}, {'label': 'ScanNav Anatomy PNB unaided', 'description': 'Participants completing scans for regional anaesthesia without the aid of ScanNav Anatomy PNB.'}], 'interventions': [{'name': 'ScanNav Anatomy PNB', 'type': 'DEVICE', 'description': 'AI-powered device that highlights anatomy of interest during ultrasound scans.', 'armGroupLabels': ['ScanNav Anatomy PNB aided']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'UCH Education Centre', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'James Bowness, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intelligent Ultrasound'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IntelligentUltrasound Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}