The Effects of the STAR Maneuver on UGRA Training

NCT ID: NCT02032420

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-12-31

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.

Conditions

Simulator-based Training of Ultrasound-guided Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

STAR

Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.

Group Type: EXPERIMENTAL

STAR

Intervention Type: BEHAVIORAL

ART

Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.

Group Type: ACTIVE_COMPARATOR

ART

Intervention Type: BEHAVIORAL

Interventions

STAR

Intervention Type: BEHAVIORAL

ART

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of New Mexico

OTHER

Sponsor Role: lead

Responsible Party

Timothy R Petersen

Research Information Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Lam

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

University of New Mexico Hospital

Albuquerque, New Mexico, United States

Countries

United States

Other Identifiers

STAR vs. ART

Identifier Type: -

Identifier Source: org_study_id