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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02032420
Enrollment
35
Registered
2014-01-10
Start date
2012-10-31
Completion date
2013-12-31
Last updated
2017-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simulator-based Training of Ultrasound-guided Regional Anesthesia

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.

Detailed description

After watching the training video, each volunteer will be placed in front of a set up identical to the video seen. Adjacent to this set up, a single fellowship trained regional anesthesiologist known as the assessor is situated with a screen that allows real time viewing of the ultrasound screen seen by the volunteer. The assessor is blinded to the assignment of the volunteer. Also, the assessor does not have any visualization of the volunteer. This prevents visualizing hand or body movement that may cause a bias. The same assessor is used for the whole study to provide consistent assessment of the task. The task involves the volunteer directing an 80 mm echogenic Pajunk needle into 3 targets in a standardized homemade phantom. The targets simulate the nerve roots commonly found in the interscalene block. Thus, they are arranged diagonally to simulate the nerve root position commonly seen. Also, they are arranged on a tilt relative to the flat surface of the phantom to simulate the direction the nerve travels. This is important as the tilt of the target requires the volunteer to tilt the probe so that their incidental ultrasound wave is perpendicular to the target for the brightest reflection to occur. This phenomenon is known as anisotropy. This increases the realism of the task that cannot be imitated by commercially available phantoms. There are 3 goals that the volunteer must fulfill in performing their task. Firstly, they must direct the needle to the 12 o'clock position of the 3 targets. Secondly, they must achieve maximal ultrasound image brightness of the 3 targets at all times. Thirdly, the entire needle must be visualized at all times. If the needle is not in the correct position, the assessor will verbally inform the volunteer to redirect it to the correct position. If the target images are not at their brightest, the assessor will verbally inform the volunteer not to manipulate the needle towards the target until the targets are at their brightest. Clinically, this functions to prevent the needle being inserted inside the nerve as the targets are not clearly seen. Thirdly, if the needle is visualized entirely, the volunteer will be told to stop manipulating the needle towards the target until the needle is fully visualized by manipulating the probe. A timer records the cumulative time the needle is not in full visualization. Clinically, this functions to prevent the needle being inserted into a nerve or structure that it should not. After all 3 targets have been completed, the volunteer repeats the task a total of 3 times.

Interventions

BEHAVIORALSTAR
BEHAVIORALART

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy volunteers * Right handed * Aged 18 to 55

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Task Completion TimeImmediately after trainingMedian time taken to complete 3 iterations of the assigned task, across participants within a study arm

Secondary

MeasureTime frameDescription
Needle-not-seen TimeDuring attemptMedian percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm
Performer FatigueDuring taskSelf-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue

Countries

United States

Participant flow

Participants by arm

ArmCount
STAR Strategy
Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
18
ART Strategy
Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
17
Total35

Baseline characteristics

CharacteristicSTAR StrategyART StrategyTotal
Age, Continuous21 years21 years21 years
Gender
Female
7 Participants12 Participants19 Participants
Gender
Male
11 Participants5 Participants16 Participants
Plays video games7 participants8 participants15 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 180 / 17
serious
Total, serious adverse events
0 / 180 / 17

Outcome results

Primary

Task Completion Time

Median time taken to complete 3 iterations of the assigned task, across participants within a study arm

Time frame: Immediately after training

ArmMeasureValue (MEDIAN)
STAR StrategyTask Completion Time87 seconds
ART StrategyTask Completion Time343 seconds
p-value: <0.001Repeated-measures MANOVA
Secondary

Needle-not-seen Time

Median percentage of attempt time on 3 iterations in which the needle is not adequately visualized, across participants within a study arm

Time frame: During attempt

ArmMeasureValue (MEDIAN)
STAR StrategyNeedle-not-seen Time42.8 percentage of attempt time
ART StrategyNeedle-not-seen Time68.7 percentage of attempt time
p-value: 0.004Repeated-measures MANOVA
Secondary

Performer Fatigue

Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue

Time frame: During task

ArmMeasureValue (MEDIAN)
STAR StrategyPerformer Fatigue1 units on a scale
ART StrategyPerformer Fatigue4.5 units on a scale
p-value: 0.038Wilcoxon (Mann-Whitney)
Post Hoc

Inability to Complete Assigned Task at All in Three Attempts

Some participants found the task too difficult to complete.

Time frame: Immediately after training

ArmMeasureValue (NUMBER)
STAR StrategyInability to Complete Assigned Task at All in Three Attempts0 participants
ART StrategyInability to Complete Assigned Task at All in Three Attempts7 participants
p-value: 0.003Fisher Exact

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026