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

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.

Study Overview

• Status: Completed
• Conditions: Simulator-based Training of Ultrasound-guided Regional Anesthesia
• Intervention / Treatment: Behavioral: STAR; Behavioral: ART

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAR; Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.	Behavioral: STAR
Active Comparator: ART; Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.	Behavioral: ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task Completion Time	Median time taken to complete 3 iterations of the assigned task, across participants within a study arm	Immediately after training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During attempt
Performer Fatigue	Self-reported trainee fatigue on a numerical rating scale (1= least fatigued; 10=most fatigued); lower scores indicate less fatigue	During task

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Nicholas Lam, University of New Mexico

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 18, 2013
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: STAR vs. ART