The Effects of the STAR Maneuver on UGRA Training
A Double Blinded Randomized Controlled Trial on the Effects of Four Sequential Maneuvers on Ultrasound Guided Nerve Block Performance
1 other identifier
interventional
35
1 country
1
Brief Summary
Volunteers will watch a training video demonstrating how to place a needle in the correct position while keeping it visible. Later the volunteers will be placed in front of a set up identical to the video, and asked to demonstrate how to direct an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom a total of three times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 10, 2014
CompletedResults Posted
Study results publicly available
February 13, 2017
CompletedFebruary 13, 2017
December 1, 2016
1.2 years
December 18, 2013
October 25, 2016
December 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Task Completion Time
Median time taken to complete 3 iterations of the assigned task, across participants within a study arm
Immediately after training
Secondary Outcomes (2)
Needle-not-seen Time
During attempt
Performer Fatigue
During task
Study Arms (2)
STAR
EXPERIMENTALIntroductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
ART
ACTIVE COMPARATORIntroductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
- Right handed
- Aged 18 to 55
You may not qualify if:
- Any person who has prior knowledge about ultrasound imaging or regional anesthesia
- Any person who has prior experience with laparoscopy or biopsy
- Any person who has problems with depth of field or simple hand eye co-ordination task
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of New Mexico Hospital
Albuquerque, New Mexico, 87106, United States
Results Point of Contact
- Title
- Dr. Nicholas Lam
- Organization
- University of New Mexico
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas Lam
University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Information Specialist
Study Record Dates
First Submitted
December 18, 2013
First Posted
January 10, 2014
Study Start
October 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 13, 2017
Results First Posted
February 13, 2017
Record last verified: 2016-12