Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-06 @ 6:45 PM
Study NCT ID:
NCT01690156
Status:
TERMINATED
Last Update Posted:
2024-01-10
First Post:
2012-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'This is not a clinical trial and was inadvertently entered in the system.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2012-09-17', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time taken to perform a simulated interscalene block', 'timeFrame': '1 hour', 'description': 'Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets'}], 'secondaryOutcomes': [{'measure': 'Duration where the entire needle is not visualized when performing the simulated interscalene block', 'timeFrame': '1 hour', 'description': 'Time taken to perform a simulated interscalene block after watching an instructional video on ultrasound guided regional anesthesia on the simulated targets'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['In-plane', 'Ultrasound-guided regional anesthesia performance', 'Probe position', 'Needle visualization'], 'conditions': ['In-plane Ultrasound-guided Regional Anesthesia Performance']}, 'descriptionModule': {'briefSummary': 'Ultrasound has been used to guide a needle to inject local anesthetics around nerves. This is usually done in the same plane as the ultrasound beam in America and is known as an in-plane technique. When done correctly, the entire needle is visualized on the ultrasound screen as it approaches the nerves which are also seen on the same screen the entire time. The ultrasound probe can be held perpendicular or parallel to the shoulders of the person performing the in-plane technique. Our hypothesis is that holding the ultrasound probe perpendicular to the shoulder is superior to holding the probe parallel to the shoulder during an in-plane ultrasound guided regional anesthesia technique.', 'detailedDescription': 'Right handed volunteers with no prior exposure to ultrasound techniques are used in this study. They will be randomly assigned to be shown an instructional video on how to perform an in-plane ultrasound guided needling technique on a realistic simulation target. The two videos are identical with the exception of the probe position. A blinded assessor will time the volunteers performance behind a screen and note the duration in which the needle is not visualized in the ultrasound screen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers naiive to ultrasound techniques', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n* Right handed\n* Aged 18 to 55\n\nExclusion Criteria:\n\n* Any person who has prior knowledge about ultrasound imaging or regional anesthesia\n* Any person who has prior experience with laparoscopy or biopsy\n* Any person who has problems with depth of field or simple hand eye co-ordination task'}, 'identificationModule': {'nctId': 'NCT01690156', 'briefTitle': 'Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Double Blinded Randomized Control Trial on the Effects of Ultrasound Probe Position on Ultrasound-guided Nerve Blocks', 'orgStudyIdInfo': {'id': 'Probeposition'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parallel Probe Position', 'description': 'Performing the simulated interscalene block with the ultrasound probe parallel to the shoulders of the person performing the block'}, {'label': 'Perpendicular Probe Position', 'description': 'Performing the simulated interscalene block with the ultrasound probe perpendicular to the shoulders of the person performing the block'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87120', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Nicholas C Lam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}